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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011137-26 | EudraCT Number | ||
| CTRI/2009/091/000883 | Registry Identifier | CTRI |
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Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.
Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC-GLM50 | Experimental | In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment. |
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| IV GLM 2 mg/kg + GLM50-SC | Experimental | After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment. |
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| GLM50-SC | Experimental | After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC golimumab | Biological | Subcutaneous golimumab at a dose of 50 mg administered once monthly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 | EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units | Month 6 |
| Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. | Start of Month 11, End of Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
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Inclusion Criteria:
For Part 1:
Age >=18 years, either sex, any race.
Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
Active disease despite DMARD treatment
Subject must be taking at least one of the allowed DMARDs, and must be able to continue with it during the trial.
Eligibility for anti tumor necrosis factor (TNF) use according to the following criteria:
For Part 2:
Participant must have completed Part 1 of this trial.
Participant must have:
Both the investigator and the subject must agree to switch the participant's treatment to IV administration as may be required in Part 2 of this trial.
The investigator must judge that no safety events (eg, serious adverse events [SAEs], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23740226 | Result | Combe B, Dasgupta B, Louw I, Pal S, Wollenhaupt J, Zerbini CA, Beaulieu AD, Schulze-Koops H, Durez P, Yao R, Vastesaeger N, Weng HH; GO-MORE Investigators. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study. Ann Rheum Dis. 2014 Aug;73(8):1477-86. doi: 10.1136/annrheumdis-2013-203229. Epub 2013 Jun 5. | |
| 28431485 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Golimumab 50 mg Subcutaneous (GLM50-SC) | Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1. |
| FG001 | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly. |
| FG002 | SC-GLM50 | Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Part 1 |
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| Study Part 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | GLM50-SC | Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 | EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units | The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation. | Posted | Number | Participants | Month 6 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Golimumab 50 mg Subcutaneous (GLM50-SC) | Participants received GLM50-SC once monthly for a period of 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| C529000 | golimumab |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| IV golimumab | Biological | Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight. |
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| Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Number of Participants Who Achieved DAS28-ESR EULAR Response | EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2. | Month 2, Month 4, Month 6 |
| Number of Participants Who Achieved DAS28-CRP EULAR Response | DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6. | Month 2, Month 4, Month 6 |
| Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6 | The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0. | Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Number of Participants Who Achieved Minimal or Absence of Functional Impairment | The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. | Month 2, Month 4, Month 6 |
| Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | Baseline, Month 2, Month 4, Month 6 |
| Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | Baseline, Month 2, Month 4, Month 6 |
| Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8 | The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS. | Month 2, Month 4, Month 6 |
| Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12 | The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time. The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale. | End of Month 6, End of Month 12 |
| Percentage of Participants Achieving Remission | Remission was defined as achievement of a DAS28-ESR < 2.6. | Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12 |
| Durez P, Vanthuyne M, Soyfoo MS, Hoffman I, Malaise M, Geusens P. Efficacy of golimumab in Belgian patients with active rheumatoid arthritis despite treatment with non-biologic disease-modifying anti-rheumatic drugs: sub-analysis of the GO-MORE study. Acta Clin Belg. 2017 Dec;72(6):424-428. doi: 10.1080/17843286.2017.1314079. Epub 2017 Apr 21. |
| 25664404 | Derived | Schulze-Koops H, Giacomelli R, Samborski W, Rednic S, Herold M, Yao R, Govoni M, Vastesaeger N, Weng HH. Factors influencing the patient evaluation of injection experience with the SmartJect autoinjector in rheumatoid arthritis. Clin Exp Rheumatol. 2015 Mar-Apr;33(2):201-8. Epub 2015 Jan 29. |
| 24839031 | Derived | Dasgupta B, Combe B, Louw I, Wollenhaupt J, Zerbini CA, Beaulieu A, Schulze-Koops H, Durez P, Wolff V, Yao R, Weng HH, Govoni M, Vastesaeger N. Patient and physician expectations of add-on treatment with golimumab for rheumatoid arthritis: relationships between expectations and clinical and quality of life outcomes. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1799-807. doi: 10.1002/acr.22371. |
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| Primary | Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. | Posted | Number | Participants | Start of Month 11, End of Month 12 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Swollen Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6 | The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Tender Joints | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mm/h | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR or at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] - 10 cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Number of Participants Who Achieved DAS28-ESR EULAR Response | EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Number | Participants | Month 2, Month 4, Month 6 |
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| Secondary | Number of Participants Who Achieved DAS28-CRP EULAR Response | DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. | Posted | Number | Participants | Month 2, Month 4, Month 6 |
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| Secondary | Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6 | The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. | Posted | Number | Participants | Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Number of Participants Who Achieved Minimal or Absence of Functional Impairment | The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. | Posted | Number | Participants | Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6 | Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst). | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6 | The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 2, Month 4, Month 6 |
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| Secondary | Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8 | The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS. | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. | Posted | Number | Participants | Month 2, Month 4, Month 6 |
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| Secondary | Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12 | The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time. The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale. | 8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively. | Posted | Mean | Standard Deviation | Units on a Scale | End of Month 6, End of Month 12 |
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| Secondary | Percentage of Participants Achieving Remission | Remission was defined as achievement of a DAS28-ESR < 2.6. | 8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12 |
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|
|
| 203 |
| 3,357 |
| 0 |
| 3,357 |
| EG001 | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly. | 17 | 245 | 28 | 245 |
| EG002 | SC-GLM50 | Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study. | 7 | 255 | 24 | 255 |
| Arthritis bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Tuberculosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Peritonsillar abcess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Rotavirus infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Abcess oral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Groin abcess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Herpes zoster oticus | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Listeria sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Ludwig angina | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Syphillis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Tracheitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lumbar spine stenosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Meniscal degeneration | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Polychondritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Ankle fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Diffuse large B-cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Appendix disorder | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lumbar hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oesophageal varicies hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Small intestine obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lung cyst | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial fibriliation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Calcinosis | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nephrolithiases | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal amyloidosis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arterial bypass operation | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Lymphadenectomy | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Open angle glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conductive deafness | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
Investigator is granted the right to use the results of all work under this study including but not limited to, the results of tests and any raw data and statistical data generated for investigator's own teaching, research, and publication purposes only. Investigator/Institution agrees, on behalf of itself and its employees, officers, trustees, and agents, not to cause said results to be knowingly used for any commercial purpose whatsoever except as authorized by the sponsor in writing.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1995) |
|
| High MTX Dose - Month 4 (n=1995) |
|
| High MTX Dose - Month 6 (n=1995) |
|
|
| DMARD Combination 2 - Month 2 (n=433) |
|
| DMARD Combination 2 - Month 4 (n=433) |
|
| DMARD Combination 2 - Month 6 (n=433) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=106) |
|
| DMARD Combination 5 - Month 4 (n=106) |
|
| DMARD Combination 5 - Month 6 (n=106) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2078) |
|
| Received Corticosteroids - Month 4 (n=2078) |
|
| Received Corticosteroids - Month 6 (n=2078) |
|
|
| Failed 2 DMARDs - Month 2 (n=1176) |
|
| Failed 2 DMARDs - Month 4 (n=1176) |
|
| Failed 2 DMARDs - Month 6 (n=1176) |
|
| Failed >=3 DMARDs - Month 2 (n=974) |
|
| Failed >=3 DMARDs - Month 4 (n=974) |
|
| Failed >=3 DMARDs - Month 6 (n=974) |
|
|
| Duration 2 to <5 years - Month 2 (n=764) |
|
| Duration 2 to <5 years - Month 4 (n=764) |
|
| Duration 2 to <5 years - Month 6 (n=764) |
|
| Duration 5 to 10 years - Month 2 (n=692) |
|
| Duration 5 to 10 years - Month 4 (n=692) |
|
| Duration 5 to 10 years - Month 6 (n=692) |
|
| Duration > 10 years - Month 2 (n=924) |
|
| Duration > 10 years - Month 4 (n=924) |
|
| Duration > 10 years - Month 6 (n=924) |
|
|
| DAS28 > 5.1 - Month 2 (n=2572) |
|
| DAS28 > 5.1 - Month 4 (n=2572) |
|
| DAS28 > 5.1 - Month 6 (n=2572) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1081) |
|
| RF >146 IU/mL - Month 2 (n=1127) |
|
| RF >146 IU/mL - Month 4 (n=1127) |
|
| RF >146 IU/mL - Month 6 (n=1127) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1075) |
|
| Title | Measurements |
|---|---|
|
| Smoking history >=20 years - Month 2 (n=324) |
|
| Smoking history >=20 years - Month 4 (n=324) |
|
| Smoking history >=20 years - Month 6 (n=324) |
|
| Smoking history <20 years - Month 2 (n=314) |
|
| Smoking history <20 years - Month 4 (n=314) |
|
| Smoking history <20 years - Month 6 (n=314) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=397) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=423) |
|
| Pack years <7.5 - Month 4 (n=423) |
|
| Pack years <7.5 - Month 6 (n=423) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=454) |
|
| Pack years >20.5 - Month 2 (n=418) |
|
| Pack years >20.5 - Month 4 (n=418) |
|
| Pack years >20.5 - Month 6 (n=418) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3174) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1009) |
|
| >1.5 to 1.86 - Month 4 (n=1009) |
|
| >1.5 to 1.86 - Month 6 (n=1009) |
|
| >=1.86 - Month 2 (n=1054) |
|
| >=1.86 - Month 4 (n=1054) |
|
| >=1.86 - Month 6 (n=1054) |
|
| Title | Measurements |
|---|---|
|
| >10 to 20 years - Month 2 (n=1105) |
|
| >10 to 20 years - Month 4 (n=1105) |
|
| >10 to 20 years - Month 6 (n=1105) |
|
| >20 years - Month 2 (n=850) |
|
| >20 years - Month 4 (n=850) |
|
| >20 years - Month 6 (n=850) |
|
|
| 6 to 10 years - Month 2 (n=1745) |
|
| 6 to 10 years - Month 4 (n=1745) |
|
| 6 to 10 years - Month 6 (n=1745) |
|
| >10 years - Month 2 (n=355) |
|
| >10 years - Month 4 (n=355) |
|
| >10 years - Month 6 (n=355) |
|
|
| 18-34 patients in prior month - Month 2 (n=1061) |
|
| 18-34 patients in prior month - Month 4 (n=1061) |
|
| 18-34 patients in prior month - Month 6 (n=1061) |
|
| >=35 patients in prior month - Month 2 (n=1097) |
|
| >=35 patients in prior month - Month 4 (n=1097) |
|
| >=35 patients in prior month - Month 6 (n=1097) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1932) |
|
| Low disease activity - Month 4 (n=1932) |
|
| Low disease activity - Month 6 (n=1932) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1995) |
|
| High MTX Dose - Month 4 (n=1995) |
|
| High MTX Dose - Month 6 (n=1995) |
|
|
| DMARD Combination 2 - Month 2 (n=433) |
|
| DMARD Combination 2 - Month 4 (n=433) |
|
| DMARD Combination 2 - Month 6 (n=433) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=106) |
|
| DMARD Combination 5 - Month 4 (n=106) |
|
| DMARD Combination 5 - Month 6 (n=106) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2078) |
|
| Received Corticosteroids - Month 4 (n=2078) |
|
| Received Corticosteroids - Month 6 (n=2078) |
|
|
| Failed 2 DMARDs - Month 2 (n=1176) |
|
| Failed 2 DMARDs - Month 4 (n=1176) |
|
| Failed 2 DMARDs - Month 6 (n=1176) |
|
| Failed >=3 DMARDs - Month 2 (n=974) |
|
| Failed >=3 DMARDs - Month 4 (n=974) |
|
| Failed >=3 DMARDs - Month 6 (n=974) |
|
|
| Duration 2 to <5 years - Month 2 (n=764) |
|
| Duration 2 to <5 years - Month 4 (n=764) |
|
| Duration 2 to <5 years - Month 6 (n=764) |
|
| Duration 5 to 10 years - Month 2 (n=692) |
|
| Duration 5 to 10 years - Month 4 (n=692) |
|
| Duration 5 to 10 years - Month 6 (n=692) |
|
| Duration > 10 years - Month 2 (n=924) |
|
| Duration > 10 years - Month 4 (n=924) |
|
| Duration > 10 years - Month 6 (n=924) |
|
|
| DAS28 > 5.1 - Month 2 (n=2572) |
|
| DAS28 > 5.1 - Month 4 (n=2572) |
|
| DAS28 > 5.1 - Month 6 (n=2572) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1081) |
|
| RF >146 IU/mL - Month 2 (n=1127) |
|
| RF >146 IU/mL - Month 4 (n=1127) |
|
| RF >146 IU/mL - Month 6 (n=1127) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1075) |
|
| Title | Measurements |
|---|---|
|
| Smoking history >=20 years - Month 2 (n=324) |
|
| Smoking history >=20 years - Month 4 (n=324) |
|
| Smoking history >=20 years - Month 6 (n=324) |
|
| Smoking history <20 years - Month 2 (n=314) |
|
| Smoking history <20 years - Month 4 (n=314) |
|
| Smoking history <20 years - Month 6 (n=314) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=397) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=423) |
|
| Pack years <7.5 - Month 4 (n=423) |
|
| Pack years <7.5 - Month 6 (n=423) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=454) |
|
| Pack years >20.5 - Month 2 (n=418) |
|
| Pack years >20.5 - Month 4 (n=418) |
|
| Pack years >20.5 - Month 6 (n=418) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3174) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1009) |
|
| >1.5 to 1.86 - Month 4 (n=1009) |
|
| >1.5 to 1.86 - Month 6 (n=1009) |
|
| >=1.86 - Month 2 (n=1054) |
|
| >=1.86 - Month 4 (n=1054) |
|
| >=1.86 - Month 6 (n=1054) |
|
| Title | Measurements |
|---|---|
|
| >10 to 20 years - Month 2 (n=1105) |
|
| >10 to 20 years - Month 4 (n=1105) |
|
| >10 to 20 years - Month 6 (n=1105) |
|
| >20 years - Month 2 (n=850) |
|
| >20 years - Month 4 (n=850) |
|
| >20 years - Month 6 (n=850) |
|
|
| 6 to 10 years - Month 2 (n=1745) |
|
| 6 to 10 years - Month 4 (n=1745) |
|
| 6 to 10 years - Month 6 (n=1745) |
|
| >10 years - Month 2 (n=355) |
|
| >10 years - Month 4 (n=355) |
|
| >10 years - Month 6 (n=355) |
|
|
| 18-34 patients in prior month - Month 2 (n=1061) |
|
| 18-34 patients in prior month - Month 4 (n=1061) |
|
| 18-34 patients in prior month - Month 6 (n=1061) |
|
| >=35 patients in prior month - Month 2 (n=1097) |
|
| >=35 patients in prior month - Month 4 (n=1097) |
|
| >=35 patients in prior month - Month 6 (n=1097) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1932) |
|
| Low disease activity - Month 4 (n=1932) |
|
| Low disease activity - Month 6 (n=1932) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1995) |
|
| High MTX Dose - Month 4 (n=1995) |
|
| High MTX Dose - Month 6 (n=1995) |
|
|
| DMARD Combination 2 - Month 2 (n=433) |
|
| DMARD Combination 2 - Month 4 (n=433) |
|
| DMARD Combination 2 - Month 6 (n=433) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=106) |
|
| DMARD Combination 5 - Month 4 (n=106) |
|
| DMARD Combination 5 - Month 6 (n=106) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2078) |
|
| Received Corticosteroids - Month 4 (n=2078) |
|
| Received Corticosteroids - Month 6 (n=2078) |
|
|
| Failed 2 DMARDs - Month 2 (n=1176) |
|
| Failed 2 DMARDs - Month 4 (n=1176) |
|
| Failed 2 DMARDs - Month 6 (n=1176) |
|
| Failed >=3 DMARDs - Month 2 (n=974) |
|
| Failed >=3 DMARDs - Month 4 (n=974) |
|
| Failed >=3 DMARDs - Month 6 (n=974) |
|
|
| Duration 2 to <5 years - Month 2 (n=764) |
|
| Duration 2 to <5 years - Month 4 (n=764) |
|
| Duration 2 to <5 years - Month 6 (n=764) |
|
| Duration 5 to 10 years - Month 2 (n=692) |
|
| Duration 5 to 10 years - Month 4 (n=692) |
|
| Duration 5 to 10 years - Month 6 (n=692) |
|
| Duration > 10 years - Month 2 (n=924) |
|
| Duration > 10 years - Month 4 (n=924) |
|
| Duration > 10 years - Month 6 (n=924) |
|
|
| DAS28 > 5.1 - Month 2 (n=2572) |
|
| DAS28 > 5.1 - Month 4 (n=2572) |
|
| DAS28 > 5.1 - Month 6 (n=2572) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1081) |
|
| RF >146 IU/mL - Month 2 (n=1127) |
|
| RF >146 IU/mL - Month 4 (n=1127) |
|
| RF >146 IU/mL - Month 6 (n=1127) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1075) |
|
|
| Smoking history >=20 years - Month 2 (n=324) |
|
| Smoking history >=20 years - Month 4 (n=324) |
|
| Smoking history >=20 years - Month 6 (n=324) |
|
| Smoking history <20 years - Month 2 (n=314) |
|
| Smoking history <20 years - Month 4 (n=314) |
|
| Smoking history <20 years - Month 6 (n=314) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=397) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=423) |
|
| Pack years <7.5 - Month 4 (n=423) |
|
| Pack years <7.5 - Month 6 (n=423) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=454) |
|
| Pack years >20.5 - Month 2 (n=418) |
|
| Pack years >20.5 - Month 4 (n=418) |
|
| Pack years >20.5 - Month 6 (n=418) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3174) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1009) |
|
| >1.5 to 1.86 - Month 4 (n=1009) |
|
| >1.5 to 1.86 - Month 6 (n=1009) |
|
| >=1.86 - Month 2 (n=1054) |
|
| >=1.86 - Month 4 (n=1054) |
|
| >=1.86 - Month 6 (n=1054) |
|
|
| >10 to 20 years - Month 2 (n=1105) |
|
| >10 to 20 years - Month 4 (n=1105) |
|
| >10 to 20 years - Month 6 (n=1105) |
|
| >20 years - Month 2 (n=850) |
|
| >20 years - Month 4 (n=850) |
|
| >20 years - Month 6 (n=850) |
|
|
| 6 to 10 years - Month 2 (n=1745) |
|
| 6 to 10 years - Month 4 (n=1745) |
|
| 6 to 10 years - Month 6 (n=1745) |
|
| >10 years - Month 2 (n=355) |
|
| >10 years - Month 4 (n=355) |
|
| >10 years - Month 6 (n=355) |
|
|
| 18-34 patients in prior month - Month 2 (n=1061) |
|
| 18-34 patients in prior month - Month 4 (n=1061) |
|
| 18-34 patients in prior month - Month 6 (n=1061) |
|
| >=35 patients in prior month - Month 2 (n=1097) |
|
| >=35 patients in prior month - Month 4 (n=1097) |
|
| >=35 patients in prior month - Month 6 (n=1097) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1932) |
|
| Low disease activity - Month 4 (n=1932) |
|
| Low disease activity - Month 6 (n=1932) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1995) |
|
| High MTX Dose - Month 4 (n=1995) |
|
| High MTX Dose - Month 6 (n=1995) |
|
|
| DMARD Combination 2 - Month 2 (n=433) |
|
| DMARD Combination 2 - Month 4 (n=433) |
|
| DMARD Combination 2 - Month 6 (n=433) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=106) |
|
| DMARD Combination 5 - Month 4 (n=106) |
|
| DMARD Combination 5 - Month 6 (n=106) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2078) |
|
| Received Corticosteroids - Month 4 (n=2078) |
|
| Received Corticosteroids - Month 6 (n=2078) |
|
|
| Failed 2 DMARDs - Month 2 (n=1176) |
|
| Failed 2 DMARDs - Month 4 (n=1176) |
|
| Failed 2 DMARDs - Month 6 (n=1176) |
|
| Failed >=3 DMARDs - Month 2 (n=974) |
|
| Failed >=3 DMARDs - Month 4 (n=974) |
|
| Failed >=3 DMARDs - Month 6 (n=974) |
|
|
| Duration 2 to <5 years - Month 2 (n=764) |
|
| Duration 2 to <5 years - Month 4 (n=764) |
|
| Duration 2 to <5 years - Month 6 (n=764) |
|
| Duration 5 to 10 years - Month 2 (n=692) |
|
| Duration 5 to 10 years - Month 4 (n=692) |
|
| Duration 5 to 10 years - Month 6 (n=692) |
|
| Duration > 10 years - Month 2 (n=924) |
|
| Duration > 10 years - Month 4 (n=924) |
|
| Duration > 10 years - Month 6 (n=924) |
|
|
| DAS28 > 5.1 - Month 2 (n=2572) |
|
| DAS28 > 5.1 - Month 4 (n=2572) |
|
| DAS28 > 5.1 - Month 6 (n=2572) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1081) |
|
| RF >146 IU/mL - Month 2 (n=1127) |
|
| RF >146 IU/mL - Month 4 (n=1127) |
|
| RF >146 IU/mL - Month 6 (n=1127) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1075) |
|
|
| Smoking history >=20 years - Month 2 (n=324) |
|
| Smoking history >=20 years - Month 4 (n=324) |
|
| Smoking history >=20 years - Month 6 (n=324) |
|
| Smoking history <20 years - Month 2 (n=314) |
|
| Smoking history <20 years - Month 4 (n=314) |
|
| Smoking history <20 years - Month 6 (n=314) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=397) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=423) |
|
| Pack years <7.5 - Month 4 (n=423) |
|
| Pack years <7.5 - Month 6 (n=423) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=454) |
|
| Pack years >20.5 - Month 2 (n=418) |
|
| Pack years >20.5 - Month 4 (n=418) |
|
| Pack years >20.5 - Month 6 (n=418) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3174) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1009) |
|
| >1.5 to 1.86 - Month 4 (n=1009) |
|
| >1.5 to 1.86 - Month 6 (n=1009) |
|
| >=1.86 - Month 2 (n=1054) |
|
| >=1.86 - Month 4 (n=1054) |
|
| >=1.86 - Month 6 (n=1054) |
|
| Title | Measurements |
|---|---|
|
| >10 to 20 years - Month 2 (n=1105) |
|
| >10 to 20 years - Month 4 (n=1105) |
|
| >10 to 20 years - Month 6 (n=1105) |
|
| >20 years - Month 2 (n=850) |
|
| >20 years - Month 4 (n=850) |
|
| >20 years - Month 6 (n=850) |
|
|
| 6 to 10 years - Month 2 (n=1745) |
|
| 6 to 10 years - Month 4 (n=1745) |
|
| 6 to 10 years - Month 6 (n=1745) |
|
| >10 years - Month 2 (n=355) |
|
| >10 years - Month 4 (n=355) |
|
| >10 years - Month 6 (n=355) |
|
|
| 18-34 patients in prior month - Month 2 (n=1061) |
|
| 18-34 patients in prior month - Month 4 (n=1061) |
|
| 18-34 patients in prior month - Month 6 (n=1061) |
|
| >=35 patients in prior month - Month 2 (n=1097) |
|
| >=35 patients in prior month - Month 4 (n=1097) |
|
| >=35 patients in prior month - Month 6 (n=1097) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1932) |
|
| Low disease activity - Month 4 (n=1932) |
|
| Low disease activity - Month 6 (n=1932) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
|
| Medium MTX Dose - Month 2 (n=519) |
|
| Medium MTX Dose - Month 4 (n=519) |
|
| Medium MTX Dose - Month 6 (n=519) |
|
| High MTX Dose - Month 2 (n=1967) |
|
| High MTX Dose - Month 4 (n=1967) |
|
| High MTX Dose - Month 6 (n=1967) |
|
|
| DMARD Combination 2 - Month 2 (n=424) |
|
| DMARD Combination 2 - Month 4 (n=424) |
|
| DMARD Combination 2 - Month 6 (n=424) |
|
| DMARD Combination 3 - Month 2 (n=211) |
|
| DMARD Combination 3 - Month 4 (n=211) |
|
| DMARD Combination 3 - Month 6 (n=211) |
|
| DMARD Combination 4 - Month 2 (n=147) |
|
| DMARD Combination 4 -Month 4 (n=147) |
|
| DMARD Combination 4 - Month 6 (n=147) |
|
| DMARD Combination 5 - Month 2 (n=104) |
|
| DMARD Combination 5 - Month 4 (n=104) |
|
| DMARD Combination 5 - Month 6 (n=104) |
|
| DMARD Combination 6 - Month 2 (n=301) |
|
| DMARD Combination 6 - Month 4 (n=301) |
|
| DMARD Combination 6 - Month 6 (n=301) |
|
|
| Received Corticosteroids - Month 2 (n=2048) |
|
| Received Corticosteroids - Month 4 (n=2048) |
|
| Received Corticosteroids - Month 6 (n=2048) |
|
|
| Failed 2 DMARDs - Month 2 (n=1158) |
|
| Failed 2 DMARDs - Month 4 (n=1158) |
|
| Failed 2 DMARDs - Month 6 (n=1158) |
|
| Failed >=3 DMARDs - Month 2 (n=958) |
|
| Failed >=3 DMARDs - Month 4 (n=958) |
|
| Failed >=3 DMARDs - Month 6 (n=958) |
|
|
| Duration 2 to <5 years - Month 2 (n=756) |
|
| Duration 2 to <5 years - Month 4 (n=756) |
|
| Duration 2 to <5 years - Month 6 (n=756) |
|
| Duration 5 to 10 years - Month 2 (n=681) |
|
| Duration 5 to 10 years - Month 4 (n=681) |
|
| Duration 5 to 10 years - Month 6 (n=681) |
|
| Duration > 10 years - Month 2 (n=912) |
|
| Duration > 10 years - Month 4 (n=912) |
|
| Duration > 10 years - Month 6 (n=912) |
|
|
| DAS28 > 5.1 - Month 2 (n=2538) |
|
| DAS28 > 5.1 - Month 4 (n=2538) |
|
| DAS28 > 5.1 - Month 6 (n=2538) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1079) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1079) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1079) |
|
| RF >146 IU/mL - Month 2 (n=1125) |
|
| RF >146 IU/mL - Month 4 (n=1125) |
|
| RF >146 IU/mL - Month 6 (n=1125) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1101) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1101) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1101) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1070) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1070) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1070) |
|
|
| Smoking history >=20 years - Month 2 (n=318) |
|
| Smoking history >=20 years - Month 4 (n=318) |
|
| Smoking history >=20 years - Month 6 (n=318) |
|
| Smoking history <20 years - Month 2 (n=312) |
|
| Smoking history <20 years - Month 4 (n=312) |
|
| Smoking history <20 years - Month 6 (n=312) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=218) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=218) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=218) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=388) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=388) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=388) |
|
| Currently smokes >1 packs/day - Month 2 (n=58) |
|
| Currently smokes >1 packs/day - Month 4 (n=58) |
|
| Currently smokes >1 packs/day - Month 6 (n=58) |
|
| Pack years <7.5 - Month 2 (n=418) |
|
| Pack years <7.5 - Month 4 (n=418) |
|
| Pack years <7.5 - Month 6 (n=418) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=450) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=450) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=450) |
|
| Pack years >20.5 - Month 2 (n=405) |
|
| Pack years >20.5 - Month 4 (n=405) |
|
| Pack years >20.5 - Month 6 (n=405) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3130) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3130) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3130) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=995) |
|
| >1.5 to 1.86 - Month 4 (n=995) |
|
| >1.5 to 1.86 - Month 6 (n=995) |
|
| >=1.86 - Month 2 (n=1034) |
|
| >=1.86 - Month 4 (n=1034) |
|
| >=1.86 - Month 6 (n=1034) |
|
|
| >10 to 20 years - Month 2 (n=1094) |
|
| >10 to 20 years - Month 4 (n=1094) |
|
| >10 to 20 years - Month 6 (n=1094) |
|
| >20 years - Month 2 (n=837) |
|
| >20 years - Month 4 (n=837) |
|
| >20 years - Month 6 (n=837) |
|
|
| 6 to 10 years - Month 2 (n=1717) |
|
| 6 to 10 years - Month 4 (n=1717) |
|
| 6 to 10 years - Month 6 (n=1717) |
|
| >10 years - Month 2 (n=351) |
|
| >10 years - Month 4 (n=351) |
|
| >10 years - Month 6 (n=351) |
|
|
| 18-34 patients in prior month - Month 2 (n=1049) |
|
| 18-34 patients in prior month - Month 4 (n=1049) |
|
| 18-34 patients in prior month - Month 6 (n=1049) |
|
| >=35 patients in prior month - Month 2 (n=1077) |
|
| >=35 patients in prior month - Month 4 (n=1077) |
|
| >=35 patients in prior month - Month 6 (n=1077) |
|
|
| Moderate disease activity - Month 2 (n=313) |
|
| Moderate disease activity - Month 4 (n=313) |
|
| Moderate disease activity - Month 6 (n=313) |
|
| Low disease activity - Month 2 (n=1906) |
|
| Low disease activity - Month 4 (n=1906) |
|
| Low disease activity - Month 6 (n=1906) |
|
| Remission - Month 2 (n=959) |
|
| Remission - Month 4 (n=959) |
|
| Remission - Month 6 (n=959) |
|
|
| Medium MTX Dose - Month 2 (n=523) |
|
| Medium MTX Dose - Month 4 (n=523) |
|
| Medium MTX Dose - Month 6 (n=523) |
|
| High MTX Dose - Month 2 (n=1987) |
|
| High MTX Dose - Month 4 (n=1987) |
|
| High MTX Dose - Month 6 (n=1987) |
|
|
| DMARD Combination 2 - Month 2 (n=432) |
|
| DMARD Combination 2 - Month 4 (n=432) |
|
| DMARD Combination 2 - Month 6 (n=432) |
|
| DMARD Combination 3 - Month 2 (n=215) |
|
| DMARD Combination 3 - Month 4 (n=215) |
|
| DMARD Combination 3 - Month 6 (n=215) |
|
| DMARD Combination 4 - Month 2 (n=149) |
|
| DMARD Combination 4 -Month 4 (n=149) |
|
| DMARD Combination 4 - Month 6 (n=149) |
|
| DMARD Combination 5 - Month 2 (n=105) |
|
| DMARD Combination 5 - Month 4 (n=105) |
|
| DMARD Combination 5 - Month 6 (n=105) |
|
| DMARD Combination 6 - Month 2 (n=302) |
|
| DMARD Combination 6 - Month 4 (n=302) |
|
| DMARD Combination 6 - Month 6 (n=302) |
|
|
| Received Corticosteroids - Month 2 (n=2069) |
|
| Received Corticosteroids - Month 4 (n=2069) |
|
| Received Corticosteroids - Month 6 (n=2069) |
|
|
| Failed 2 DMARDs - Month 2 (n=1171) |
|
| Failed 2 DMARDs - Month 4 (n=1171) |
|
| Failed 2 DMARDs - Month 6 (n=1171) |
|
| Failed >=3 DMARDs - Month 2 (n=970) |
|
| Failed >=3 DMARDs - Month 4 (n=970) |
|
| Failed >=3 DMARDs - Month 6 (n=970) |
|
|
| Duration 2 to <5 years - Month 2 (n=761) |
|
| Duration 2 to <5 years - Month 4 (n=761) |
|
| Duration 2 to <5 years - Month 6 (n=761) |
|
| Duration 5 to 10 years - Month 2 (n=688) |
|
| Duration 5 to 10 years - Month 4 (n=688) |
|
| Duration 5 to 10 years - Month 6 (n=688) |
|
| Duration > 10 years - Month 2 (n=921) |
|
| Duration > 10 years - Month 4 (n=921) |
|
| Duration > 10 years - Month 6 (n=921) |
|
|
| DAS28 > 5.1 - Month 2 (n=2560) |
|
| DAS28 > 5.1 - Month 4 (n=2560) |
|
| DAS28 > 5.1 - Month 6 (n=2560) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1077) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1077) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1077) |
|
| RF >146 IU/mL - Month 2 (n=1120) |
|
| RF >146 IU/mL - Month 4 (n=1120) |
|
| RF >146 IU/mL - Month 6 (n=1120) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1105) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1105) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1105) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1071) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1071) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1071) |
|
|
| Smoking history >=20 years - Month 2 (n=323) |
|
| Smoking history >=20 years - Month 4 (n=323) |
|
| Smoking history >=20 years - Month 6 (n=323) |
|
| Smoking history <20 years - Month 2 (n=313) |
|
| Smoking history <20 years - Month 4 (n=313) |
|
| Smoking history <20 years - Month 6 (n=313) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=222) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=222) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=222) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=395) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=395) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=395) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=422) |
|
| Pack years <7.5 - Month 4 (n=422) |
|
| Pack years <7.5 - Month 6 (n=422) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=451) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=451) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=451) |
|
| Pack years >20.5 - Month 2 (n=417) |
|
| Pack years >20.5 - Month 4 (n=417) |
|
| Pack years >20.5 - Month 6 (n=417) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3161) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3161) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3161) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1005) |
|
| >1.5 to 1.86 - Month 4 (n=1005) |
|
| >1.5 to 1.86 - Month 6 (n=1005) |
|
| >=1.86 - Month 2 (n=1049) |
|
| >=1.86 - Month 4 (n=1049) |
|
| >=1.86 - Month 6 (n=1049) |
|
|
| >10 to 20 years - Month 2 (n=1101) |
|
| >10 to 20 years - Month 4 (n=1101) |
|
| >10 to 20 years - Month 6 (n=1101) |
|
| >20 years - Month 2 (n=846) |
|
| >20 years - Month 4 (n=846) |
|
| >20 years - Month 6 (n=846) |
|
|
| 6 to 10 years - Month 2 (n=1740) |
|
| 6 to 10 years - Month 4 (n=1740) |
|
| 6 to 10 years - Month 6 (n=1740) |
|
| >10 years - Month 2 (n=353) |
|
| >10 years - Month 4 (n=353) |
|
| >10 years - Month 6 (n=353) |
|
|
| 18-34 patients in prior month - Month 2 (n=1060) |
|
| 18-34 patients in prior month - Month 4 (n=1060) |
|
| 18-34 patients in prior month - Month 6 (n=1060) |
|
| >=35 patients in prior month - Month 2 (n=1095) |
|
| >=35 patients in prior month - Month 4 (n=1095) |
|
| >=35 patients in prior month - Month 6 (n=1095) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1927) |
|
| Low disease activity - Month 4 (n=1927) |
|
| Low disease activity - Month 6 (n=1927) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1995) |
|
| High MTX Dose - Month 4 (n=1995) |
|
| High MTX Dose - Month 6 (n=1995) |
|
|
| DMARD Combination 2 - Month 2 (n=433) |
|
| DMARD Combination 2 - Month 4 (n=433) |
|
| DMARD Combination 2 - Month 6 (n=433) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=106) |
|
| DMARD Combination 5 - Month 4 (n=106) |
|
| DMARD Combination 5 - Month 6 (n=106) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2078) |
|
| Received Corticosteroids - Month 4 (n=2078) |
|
| Received Corticosteroids - Month 6 (n=2078) |
|
|
| Failed 2 DMARDs - Month 2 (n=1176) |
|
| Failed 2 DMARDs - Month 4 (n=1176) |
|
| Failed 2 DMARDs - Month 6 (n=1176) |
|
| Failed >=3 DMARDs - Month 2 (n=974) |
|
| Failed >=3 DMARDs - Month 4 (n=974) |
|
| Failed >=3 DMARDs - Month 6 (n=974) |
|
|
| Duration 2 to <5 years - Month 2 (n=764) |
|
| Duration 2 to <5 years - Month 4 (n=764) |
|
| Duration 2 to <5 years - Month 6 (n=764) |
|
| Duration 5 to 10 years - Month 2 (n=692) |
|
| Duration 5 to 10 years - Month 4 (n=692) |
|
| Duration 5 to 10 years - Month 6 (n=692) |
|
| Duration > 10 years - Month 2 (n=924) |
|
| Duration > 10 years - Month 4 (n=924) |
|
| Duration > 10 years - Month 6 (n=924) |
|
|
| DAS28 > 5.1 - Month 2 (n=2572) |
|
| DAS28 > 5.1 - Month 4 (n=2572) |
|
| DAS28 > 5.1 - Month 6 (n=2572) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1081) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1081) |
|
| RF >146 IU/mL - Month 2 (n=1127) |
|
| RF >146 IU/mL - Month 4 (n=1127) |
|
| RF >146 IU/mL - Month 6 (n=1127) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1075) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1075) |
|
|
| Smoking history >=20 years - Month 2 (n=324) |
|
| Smoking history >=20 years - Month 4 (n=324) |
|
| Smoking history >=20 years - Month 6 (n=324) |
|
| Smoking history <20 years - Month 2 (n=314) |
|
| Smoking history <20 years - Month 4 (n=314) |
|
| Smoking history <20 years - Month 6 (n=314) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=397) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=423) |
|
| Pack years <7.5 - Month 4 (n=423) |
|
| Pack years <7.5 - Month 6 (n=423) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=454) |
|
| Pack years >20.5 - Month 2 (n=418) |
|
| Pack years >20.5 - Month 4 (n=418) |
|
| Pack years >20.5 - Month 6 (n=418) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3174) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3174) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1009) |
|
| >1.5 to 1.86 - Month 4 (n=1009) |
|
| >1.5 to 1.86 - Month 6 (n=1009) |
|
| >=1.86 - Month 2 (n=1054) |
|
| >=1.86 - Month 4 (n=1054) |
|
| >=1.86 - Month 6 (n=1054) |
|
|
| >10 to 20 years - Month 2 (n=1105) |
|
| >10 to 20 years - Month 4 (n=1105) |
|
| >10 to 20 years - Month 6 (n=1105) |
|
| >20 years - Month 2 (n=850) |
|
| >20 years - Month 4 (n=850) |
|
| >20 years - Month 6 (n=850) |
|
|
| 6 to 10 years - Month 2 (n=1745) |
|
| 6 to 10 years - Month 4 (n=1745) |
|
| 6 to 10 years - Month 6 (n=1745) |
|
| >10 years - Month 2 (n=355) |
|
| >10 years - Month 4 (n=355) |
|
| >10 years - Month 6 (n=355) |
|
|
| 18-34 patients in prior month - Month 2 (n=1061) |
|
| 18-34 patients in prior month - Month 4 (n=1061) |
|
| 18-34 patients in prior month - Month 6 (n=1061) |
|
| >=35 patients in prior month - Month 2 (n=1097) |
|
| >=35 patients in prior month - Month 4 (n=1097) |
|
| >=35 patients in prior month - Month 6 (n=1097) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1932) |
|
| Low disease activity - Month 4 (n=1932) |
|
| Low disease activity - Month 6 (n=1932) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
|
| Medium MTX Dose - Month 2 (n=519) |
|
| Medium MTX Dose - Month 4 (n=519) |
|
| Medium MTX Dose - Month 6 (n=519) |
|
| High MTX Dose - Month 2 (n=1967) |
|
| High MTX Dose - Month 4 (n=1967) |
|
| High MTX Dose - Month 6 (n=1967) |
|
|
| DMARD Combination 2 - Month 2 (n=424) |
|
| DMARD Combination 2 - Month 4 (n=424) |
|
| DMARD Combination 2 - Month 6 (n=424) |
|
| DMARD Combination 3 - Month 2 (n=211) |
|
| DMARD Combination 3 - Month 4 (n=211) |
|
| DMARD Combination 3 - Month 6 (n=211) |
|
| DMARD Combination 4 - Month 2 (n=147) |
|
| DMARD Combination 4 -Month 4 (n=147) |
|
| DMARD Combination 4 - Month 6 (n=147) |
|
| DMARD Combination 5 - Month 2 (n=104) |
|
| DMARD Combination 5 - Month 4 (n=104) |
|
| DMARD Combination 5 - Month 6 (n=104) |
|
| DMARD Combination 6 - Month 2 (n=301) |
|
| DMARD Combination 6 - Month 4 (n=301) |
|
| DMARD Combination 6 - Month 6 (n=301) |
|
|
| Received Corticosteroids - Month 2 (n=2048) |
|
| Received Corticosteroids - Month 4 (n=2048) |
|
| Received Corticosteroids - Month 6 (n=2048) |
|
|
| Failed 2 DMARDs - Month 2 (n=1158) |
|
| Failed 2 DMARDs - Month 4 (n=1158) |
|
| Failed 2 DMARDs - Month 6 (n=1158) |
|
| Failed >=3 DMARDs - Month 2 (n=958) |
|
| Failed >=3 DMARDs - Month 4 (n=958) |
|
| Failed >=3 DMARDs - Month 6 (n=958) |
|
|
| Duration 2 to <5 years - Month 2 (n=756) |
|
| Duration 2 to <5 years - Month 4 (n=756) |
|
| Duration 2 to <5 years - Month 6 (n=756) |
|
| Duration 5 to 10 years - Month 2 (n=681) |
|
| Duration 5 to 10 years - Month 4 (n=681) |
|
| Duration 5 to 10 years - Month 6 (n=681) |
|
| Duration > 10 years - Month 2 (n=912) |
|
| Duration > 10 years - Month 4 (n=912) |
|
| Duration > 10 years - Month 6 (n=912) |
|
|
| DAS28 > 5.1 - Month 2 (n=2538) |
|
| DAS28 > 5.1 - Month 4 (n=2538) |
|
| DAS28 > 5.1 - Month 6 (n=2538) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1079) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1079) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1079) |
|
| RF >146 IU/mL - Month 2 (n=1125) |
|
| RF >146 IU/mL - Month 4 (n=1125) |
|
| RF >146 IU/mL - Month 6 (n=1125) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1101) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1101) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1101) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1070) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1070) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1070) |
|
|
| Smoking history >=20 years - Month 2 (n=318) |
|
| Smoking history >=20 years - Month 4 (n=318) |
|
| Smoking history >=20 years - Month 6 (n=318) |
|
| Smoking history <20 years - Month 2 (n=312) |
|
| Smoking history <20 years - Month 4 (n=312) |
|
| Smoking history <20 years - Month 6 (n=312) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=218) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=218) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=218) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=388) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=388) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=388) |
|
| Currently smokes >1 packs/day - Month 2 (n=58) |
|
| Currently smokes >1 packs/day - Month 4 (n=58) |
|
| Currently smokes >1 packs/day - Month 6 (n=58) |
|
| Pack years <7.5 - Month 2 (n=418) |
|
| Pack years <7.5 - Month 4 (n=418) |
|
| Pack years <7.5 - Month 6 (n=418) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=450) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=450) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=450) |
|
| Pack years >20.5 - Month 2 (n=405) |
|
| Pack years >20.5 - Month 4 (n=405) |
|
| Pack years >20.5 - Month 6 (n=405) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3130) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3130) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3130) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=995) |
|
| >1.5 to 1.86 - Month 4 (n=995) |
|
| >1.5 to 1.86 - Month 6 (n=995) |
|
| >=1.86 - Month 2 (n=1034) |
|
| >=1.86 - Month 4 (n=1034) |
|
| >=1.86 - Month 6 (n=1034) |
|
|
| >10 to 20 years - Month 2 (n=1094) |
|
| >10 to 20 years - Month 4 (n=1094) |
|
| >10 to 20 years - Month 6 (n=1094) |
|
| >20 years - Month 2 (n=837) |
|
| >20 years - Month 4 (n=837) |
|
| >20 years - Month 6 (n=837) |
|
|
| 6 to 10 years - Month 2 (n=1717) |
|
| 6 to 10 years - Month 4 (n=1717) |
|
| 6 to 10 years - Month 6 (n=1717) |
|
| >10 years - Month 2 (n=351) |
|
| >10 years - Month 4 (n=351) |
|
| >10 years - Month 6 (n=351) |
|
|
| 18-34 patients in prior month - Month 2 (n=1049) |
|
| 18-34 patients in prior month - Month 4 (n=1049) |
|
| 18-34 patients in prior month - Month 6 (n=1049) |
|
| >=35 patients in prior month - Month 2 (n=1077) |
|
| >=35 patients in prior month - Month 4 (n=1077) |
|
| >=35 patients in prior month - Month 6 (n=1077) |
|
|
| Moderate disease activity - Month 2 (n=313) |
|
| Moderate disease activity - Month 4 (n=313) |
|
| Moderate disease activity - Month 6 (n=313) |
|
| Low disease activity - Month 2 (n=1906) |
|
| Low disease activity - Month 4 (n=1906) |
|
| Low disease activity - Month 6 (n=1906) |
|
| Remission - Month 2 (n=959) |
|
| Remission - Month 4 (n=959) |
|
| Remission - Month 6 (n=959) |
|
|
| Medium MTX Dose - Month 2 (n=516) |
|
| Medium MTX Dose - Month 4 (n=516) |
|
| Medium MTX Dose - Month 6 (n=516) |
|
| High MTX Dose - Month 2 (n=1959) |
|
| High MTX Dose - Month 4 (n=1959) |
|
| High MTX Dose - Month 6 (n=1959) |
|
|
| DMARD Combination 2 - Month 2 (n=423) |
|
| DMARD Combination 2 - Month 4 (n=423) |
|
| DMARD Combination 2 - Month 6 (n=423) |
|
| DMARD Combination 3 - Month 2 (n=210) |
|
| DMARD Combination 3 - Month 4 (n=210) |
|
| DMARD Combination 3 - Month 6 (n=210) |
|
| DMARD Combination 4 - Month 2 (n=146) |
|
| DMARD Combination 4 -Month 4 (n=146) |
|
| DMARD Combination 4 - Month 6 (n=146) |
|
| DMARD Combination 5 - Month 2 (n=103) |
|
| DMARD Combination 5 - Month 4 (n=103) |
|
| DMARD Combination 5 - Month 6 (n=103) |
|
| DMARD Combination 6 - Month 2 (n=300) |
|
| DMARD Combination 6 - Month 4 (n=300) |
|
| DMARD Combination 6 - Month 6 (n=300) |
|
|
| Received Corticosteroids - Month 2 (n=2039) |
|
| Received Corticosteroids - Month 4 (n=2039) |
|
| Received Corticosteroids - Month 6 (n=2039) |
|
|
| Failed 2 DMARDs - Month 2 (n=1153) |
|
| Failed 2 DMARDs - Month 4 (n=1153) |
|
| Failed 2 DMARDs - Month 6 (n=1153) |
|
| Failed >=3 DMARDs - Month 2 (n=954) |
|
| Failed >=3 DMARDs - Month 4 (n=954) |
|
| Failed >=3 DMARDs - Month 6 (n=954) |
|
|
| Duration 2 to <5 years - Month 2 (n=753) |
|
| Duration 2 to <5 years - Month 4 (n=753) |
|
| Duration 2 to <5 years - Month 6 (n=753) |
|
| Duration 5 to 10 years - Month 2 (n=677) |
|
| Duration 5 to 10 years - Month 4 (n=677) |
|
| Duration 5 to 10 years - Month 6 (n=677) |
|
| Duration > 10 years - Month 2 (n=909) |
|
| Duration > 10 years - Month 4 (n=909) |
|
| Duration > 10 years - Month 6 (n=909) |
|
|
| DAS28 > 5.1 - Month 2 (n=2526) |
|
| DAS28 > 5.1 - Month 4 (n=2526) |
|
| DAS28 > 5.1 - Month 6 (n=2526) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1075) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1075) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1075) |
|
| RF >146 IU/mL - Month 2 (n=1118) |
|
| RF >146 IU/mL - Month 4 (n=1118) |
|
| RF >146 IU/mL - Month 6 (n=1118) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1094) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1094) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1094) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1066) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1066) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1066) |
|
|
| Smoking history >=20 years - Month 2 (n=317) |
|
| Smoking history >=20 years - Month 4 (n=317) |
|
| Smoking history >=20 years - Month 6 (n=317) |
|
| Smoking history <20 years - Month 2 (n=311) |
|
| Smoking history <20 years - Month 4 (n=311) |
|
| Smoking history <20 years - Month 6 (n=311) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=217) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=217) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=217) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=386) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=386) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=386) |
|
| Currently smokes >1 packs/day - Month 2 (n=58) |
|
| Currently smokes >1 packs/day - Month 4 (n=58) |
|
| Currently smokes >1 packs/day - Month 6 (n=58) |
|
| Pack years <7.5 - Month 2 (n=417) |
|
| Pack years <7.5 - Month 4 (n=417) |
|
| Pack years <7.5 - Month 6 (n=417) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=447) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=447) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=447) |
|
| Pack years >20.5 - Month 2 (n=404) |
|
| Pack years >20.5 - Month 4 (n=404) |
|
| Pack years >20.5 - Month 6 (n=404) |
|
|
| Anti-TNF treatment Eligible- Month 2 (n=3117) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3117) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3117) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=991) |
|
| >1.5 to 1.86 - Month 4 (n=991) |
|
| >1.5 to 1.86 - Month 6 (n=991) |
|
| >=1.86 - Month 2 (n=1029) |
|
| >=1.86 - Month 4 (n=1029) |
|
| >=1.86 - Month 6 (n=1029) |
|
|
| >10 to 20 years - Month 2 (n=1090) |
|
| >10 to 20 years - Month 4 (n=1090) |
|
| >10 to 20 years - Month 6 (n=1090) |
|
| >20 years - Month 2 (n=833) |
|
| >20 years - Month 4 (n=833) |
|
| >20 years - Month 6 (n=833) |
|
|
| 6 to 10 years - Month 2 (n=1712) |
|
| 6 to 10 years - Month 4 (n=1712) |
|
| 6 to 10 years - Month 6 (n=1712) |
|
| >10 years - Month 2 (n=349) |
|
| >10 years - Month 4 (n=349) |
|
| >10 years - Month 6 (n=349) |
|
|
| 18-34 patients in prior month - Month 2 (n=1048) |
|
| 18-34 patients in prior month - Month 4 (n=1048) |
|
| 18-34 patients in prior month - Month 6 (n=1048) |
|
| >=35 patients in prior month - Month 2 (n=1075) |
|
| >=35 patients in prior month - Month 4 (n=1075) |
|
| >=35 patients in prior month - Month 6 (n=1075) |
|
|
| Moderate disease activity - Month 2 (n=313) |
|
| Moderate disease activity - Month 4 (n=313) |
|
| Moderate disease activity - Month 6 (n=313) |
|
| Low disease activity - Month 2 (n=1901) |
|
| Low disease activity - Month 4 (n=1901) |
|
| Low disease activity - Month 6 (n=1901) |
|
| Remission - Month 2 (n=959) |
|
| Remission - Month 4 (n=959) |
|
| Remission - Month 6 (n=959) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Low Disease Activity by DAS28-CRP - Month 2 |
|
| Low Disease Activity by DAS28-CRP - Month 4 |
|
| Low Disease Activity by DAS28-CRP - Month 6 |
|
| Low Disease Activity by SDAI - Month 2 |
|
| Low Disease Activity by SDAI - Month 4 |
|
| Low Disease Activity by SDAI - Month 6 |
|
| Remission by DAS28-ESR - Month 2 |
|
| Remission by DAS28-ESR - Month 4 |
|
| Remission by DAS28-ESR - Month 6 |
|
| Remission by DAS28-CRP - Month 2 |
|
| Remission by DAS28-CRP - Month 4 |
|
| Remission by DAS28-CRP - Month 6 |
|
| Remission by SDAI - Month 2 |
|
| Remission by SDAI - Month 4 |
|
| Remission by SDAI - Month 6 |
|
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1993) |
|
| High MTX Dose - Month 4 (n=1993) |
|
| High MTX Dose - Month 6 (n=1993) |
|
|
| DMARD Combination 2 - Month 2 (n=433) |
|
| DMARD Combination 2 - Month 4 (n=433) |
|
| DMARD Combination 2 - Month 6 (n=433) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=106) |
|
| DMARD Combination 5 - Month 4 (n=106) |
|
| DMARD Combination 5 - Month 6 (n=106) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2076) |
|
| Received Corticosteroids - Month 4 (n=2076) |
|
| Received Corticosteroids - Month 6 (n=2076) |
|
|
| Failed 2 DMARDs - Month 2 (n=1175) |
|
| Failed 2 DMARDs - Month 4 (n=1175) |
|
| Failed 2 DMARDs - Month 6 (n=1175) |
|
| Failed >=3 DMARDs - Month 2 (n=973) |
|
| Failed >=3 DMARDs - Month 4 (n=973) |
|
| Failed >=3 DMARDs - Month 6 (n=973) |
|
|
| Duration 2 to <5 years - Month 2 (n=763) |
|
| Duration 2 to <5 years - Month 4 (n=763) |
|
| Duration 2 to <5 years - Month 6 (n=763) |
|
| Duration 5 to 10 years - Month 2 (n=692) |
|
| Duration 5 to 10 years - Month 4 (n=692) |
|
| Duration 5 to 10 years - Month 6 (n=692) |
|
| Duration > 10 years - Month 2 (n=924) |
|
| Duration > 10 years - Month 4 (n=924) |
|
| Duration > 10 years - Month 6 (n=924) |
|
|
| DAS28 > 5.1 - Month 2 (n=2570) |
|
| DAS28 > 5.1 - Month 4 (n=2570) |
|
| DAS28 > 5.1 - Month 6 (n=2570) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1080) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1080) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1080) |
|
| RF >146 IU/mL - Month 2 (n=1126) |
|
| RF >146 IU/mL - Month 4 (n=1126) |
|
| RF >146 IU/mL - Month 6 (n=1126) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1112) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1112) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1074) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1074) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1074) |
|
|
| Smoking history >=20 years - Month 2 (n=324) |
|
| Smoking history >=20 years - Month 4 (n=324) |
|
| Smoking history >=20 years - Month 6 (n=324) |
|
| Smoking history <20 years - Month 2 (n=314) |
|
| Smoking history <20 years - Month 4 (n=314) |
|
| Smoking history <20 years - Month 6 (n=314) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=397) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=397) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=423) |
|
| Pack years <7.5 - Month 4 (n=423) |
|
| Pack years <7.5 - Month 6 (n=423) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=454) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=454) |
|
| Pack years >20.5 - Month 2 (n=418) |
|
| Pack years >20.5 - Month 4 (n=418) |
|
| Pack years >20.5 - Month 6 (n=418) |
|
|
| Anti-TNF treatment Eligible- Month 2 (n=3171) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3171) |
|
| EligAnti-TNF treatment Eligible - Month 6 (n=3171) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1009) |
|
| >1.5 to 1.86 - Month 4 (n=1009) |
|
| >1.5 to 1.86 - Month 6 (n=1009) |
|
| >=1.86 - Month 2 (n=1053) |
|
| >=1.86 - Month 4 (n=1053) |
|
| >=1.86 - Month 6 (n=1053) |
|
|
| >10 to 20 years - Month 2 (n=1104) |
|
| >10 to 20 years - Month 4 (n=1104) |
|
| >10 to 20 years - Month 6 (n=1104) |
|
| >20 years - Month 2 (n=850) |
|
| >20 years - Month 4 (n=850) |
|
| >20 years - Month 6 (n=850) |
|
|
| 6 to 10 years - Month 2 (n=1744) |
|
| 6 to 10 years - Month 4 (n=1744) |
|
| 6 to 10 years - Month 6 (n=1744) |
|
| >10 years - Month 2 (n=354) |
|
| >10 years - Month 4 (n=354) |
|
| >10 years - Month 6 (n=354) |
|
|
| 18-34 patients in prior month - Month 2 (n=1060) |
|
| 18-34 patients in prior month - Month 4 (n=1060) |
|
| 18-34 patients in prior month - Month 6 (n=1060) |
|
| >=35 patients in prior month - Month 2 (n=1097) |
|
| >=35 patients in prior month - Month 4 (n=1097) |
|
| >=35 patients in prior month - Month 6 (n=1097) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1930) |
|
| Low disease activity - Month 4 (n=1930) |
|
| Low disease activity - Month 6 (n=1930) |
|
| Remission - Month 2 (n=966) |
|
| Remission - Month 4 (n=966) |
|
| Remission - Month 6 (n=966) |
|
| Title | Measurements |
|---|---|
|
|
| Medium MTX Dose - Month 2 (n=526) |
|
| Medium MTX Dose - Month 4 (n=526) |
|
| Medium MTX Dose - Month 6 (n=526) |
|
| High MTX Dose - Month 2 (n=1985) |
|
| High MTX Dose - Month 4 (n=1985) |
|
| High MTX Dose - Month 6 (n=1985) |
|
|
| DMARD Combination 2 - Month 2 (n=432) |
|
| DMARD Combination 2 - Month 4 (n=432) |
|
| DMARD Combination 2 - Month 6 (n=432) |
|
| DMARD Combination 3 - Month 2 (n=216) |
|
| DMARD Combination 3 - Month 4 (n=216) |
|
| DMARD Combination 3 - Month 6 (n=216) |
|
| DMARD Combination 4 - Month 2 (n=150) |
|
| DMARD Combination 4 -Month 4 (n=150) |
|
| DMARD Combination 4 - Month 6 (n=150) |
|
| DMARD Combination 5 - Month 2 (n=105) |
|
| DMARD Combination 5 - Month 4 (n=105) |
|
| DMARD Combination 5 - Month 6 (n=105) |
|
| DMARD Combination 6 - Month 2 (n=303) |
|
| DMARD Combination 6 - Month 4 (n=303) |
|
| DMARD Combination 6 - Month 6 (n=303) |
|
|
| Received Corticosteroids - Month 2 (n=2069) |
|
| Received Corticosteroids - Month 4 (n=2069) |
|
| Received Corticosteroids - Month 6 (n=2069) |
|
|
| Failed 2 DMARDs - Month 2 (n=1173) |
|
| Failed 2 DMARDs - Month 4 (n=1173) |
|
| Failed 2 DMARDs - Month 6 (n=1173) |
|
| Failed >=3 DMARDs - Month 2 (n=970) |
|
| Failed >=3 DMARDs - Month 4 (n=970) |
|
| Failed >=3 DMARDs - Month 6 (n=970) |
|
|
| Duration 2 to <5 years - Month 2 (n=760) |
|
| Duration 2 to <5 years - Month 4 (n=760) |
|
| Duration 2 to <5 years - Month 6 (n=760) |
|
| Duration 5 to 10 years - Month 2 (n=691) |
|
| Duration 5 to 10 years - Month 4 (n=691) |
|
| Duration 5 to 10 years - Month 6 (n=691) |
|
| Duration > 10 years - Month 2 (n=923) |
|
| Duration > 10 years - Month 4 (n=923) |
|
| Duration > 10 years - Month 6 (n=923) |
|
|
| DAS28 > 5.1 - Month 2 (n=2563) |
|
| DAS28 > 5.1 - Month 4 (n=2563) |
|
| DAS28 > 5.1 - Month 6 (n=2563) |
|
|
| RF >22 to <=146 IU/mL - Month 2 (n=1079) |
|
| RF >22 to <=146 IU/mL - Month 4 (n=1079) |
|
| RF >22 to <=146 IU/mL - Month 6 (n=1079) |
|
| RF >146 IU/mL - Month 2 (n=1123) |
|
| RF >146 IU/mL - Month 4 (n=1123) |
|
| RF >146 IU/mL - Month 6 (n=1123) |
|
|
| Anti-CCP >40 to <=380 U/mL - Month 2 (n=1109) |
|
| Anti-CCP >40 to <=380 U/mL - Month 4 (n=1109) |
|
| Anti-CCP >40 to <=380 U/mL - Month 6 (n=1109) |
|
| Anti-CCP >380 U/mL - Month 2 (n=1071) |
|
| Anti-CCP >380 U/mL - Month 4 (n=1071) |
|
| Anti-CCP >380 U/mL - Month 6 (n=1071) |
|
| Title | Measurements |
|---|---|
|
| Smoking history >=20 years - Month 2 (n=322) |
|
| Smoking history >=20 years - Month 4 (n=322) |
|
| Smoking history >=20 years - Month 6 (n=322) |
|
| Smoking history <20 years - Month 2 (n=312) |
|
| Smoking history <20 years - Month 4 (n=312) |
|
| Smoking history <20 years - Month 6 (n=312) |
|
| Currently smokes <0.5 packs/day - Month 2 (n=223) |
|
| Currently smokes <0.5 packs/day - Month 4 (n=223) |
|
| Currently smokes <0.5 pack/day - Month 6 (n=223) |
|
| Currently smokes 0.5-1 pack/day - Month 2 (n=395) |
|
| Currently smokes 0.5-1 pack/day - Month 4 (n=395) |
|
| Currently smokes 0.5-1 pack/day - Month 6 (n=395) |
|
| Currently smokes >1 packs/day - Month 2 (n=59) |
|
| Currently smokes >1 packs/day - Month 4 (n=59) |
|
| Currently smokes >1 packs/day - Month 6 (n=59) |
|
| Pack years <7.5 - Month 2 (n=421) |
|
| Pack years <7.5 - Month 4 (n=421) |
|
| Pack years <7.5 - Month 6 (n=421) |
|
| Pack years 7.5 to 20.5 - Month 2 (n=453) |
|
| Pack years 7.5 to 20.5 - Month 4 (n=453) |
|
| Pack years 7.5 to 20.5 - Month 6 (n=453) |
|
| Pack years >20.5 - Month 2 (n=415) |
|
| Pack years >20.5 - Month 4 (n=415) |
|
| Pack years >20.5 - Month 6 (n=415) |
|
|
| Anti-TNF treatment Eligible - Month 2 (n=3162) |
|
| Anti-TNF treatment Eligible - Month 4 (n=3162) |
|
| Anti-TNF treatment Eligible - Month 6 (n=3162) |
|
| Title | Measurements |
|---|---|
|
| >1.5 to 1.86 - Month 2 (n=1006) |
|
| >1.5 to 1.86 - Month 4 (n=1006) |
|
| >1.5 to 1.86 - Month 6 (n=1006) |
|
| >=1.86 - Month 2 (n=1050) |
|
| >=1.86 - Month 4 (n=1050) |
|
| >=1.86 - Month 6 (n=1050) |
|
| Title | Measurements |
|---|---|
|
| >10 to 20 years - Month 2 (n=1103) |
|
| >10 to 20 years - Month 4 (n=1103) |
|
| >10 to 20 years - Month 6 (n=1103) |
|
| >20 years - Month 2 (n=847) |
|
| >20 years - Month 4 (n=847) |
|
| >20 years - Month 6 (n=847) |
|
|
| 6 to 10 years - Month 2 (n=1743) |
|
| 6 to 10 years - Month 4 (n=1743) |
|
| 6 to 10 years - Month 6 (n=1743) |
|
| >10 years - Month 2 (n=353) |
|
| >10 years - Month 4 (n=353) |
|
| >10 years - Month 6 (n=353) |
|
|
| 18-34 patients in prior month - Month 2 (n=1059) |
|
| 18-34 patients in prior month - Month 4 (n=1059) |
|
| 18-34 patients in prior month - Month 6 (n=1059) |
|
| >=35 patients in prior month - Month 2 (n=1093) |
|
| >=35 patients in prior month - Month 4 (n=1093) |
|
| >=35 patients in prior month - Month 6 (n=1093) |
|
|
| Moderate disease activity - Month 2 (n=325) |
|
| Moderate disease activity - Month 4 (n=325) |
|
| Moderate disease activity - Month 6 (n=325) |
|
| Low disease activity - Month 2 (n=1926) |
|
| Low disease activity - Month 4 (n=1926) |
|
| Low disease activity - Month 6 (n=1926) |
|
| Remission - Month 2 (n=964) |
|
| Remission - Month 4 (n=964) |
|
| Remission - Month 6 (n=964) |
|
| Title | Measurements |
|---|---|
|
| Start of Month 10 |
|
| Start of Month 11 |
|
| End of Month 12 |
|