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| ID | Type | Description | Link |
|---|---|---|---|
| B1801119 |
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The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 | As per routinary clinical practice |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| As per clinical practice | Other | As per clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6. | Month 3 |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6. | Month 6 |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6. | Month 9 |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6. |
| Measure | Description | Time Frame |
|---|---|---|
| Direct Costs | Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability. | Baseline, Months 3, 6, 9 and 12 |
| Indirect Costs | Indirect costs represent the loss of resources as a consequence of work disability or unemployment. |
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Inclusion Criteria:
Eighteen years of age or older
Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:
Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
Patients naive to anti-TNF drugs
Outpatients
Exclusion Criteria:
Patients involved in controlled or interventional trials in the 12 previous months
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Roma | 00161 | Italy |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-tumor Necrosis Factor (Anti-TNF) Agents | Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-tumor Necrosis Factor (Anti-TNF) Agents | Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months. |
| 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, Customized | Number |
| 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 | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6. | Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication. | Posted | Number | Percentage of participants | Month 3 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Anti-tumor Necrosis Factor (Anti-TNF) Agents | Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Month 12 |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 3 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | Month 3 |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | Month 6 |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 9 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | Month 9 |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | Month 12 |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 3 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | Month 3 |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 6 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | Month 6 |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 9 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | Month 9 |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 12 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | Month 12 |
| Physician Global Assessment (PGA) of Disease Activity at Month 3 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | Month 3 |
| Physician Global Assessment (PGA) of Disease Activity at Month 6 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | Month 6 |
| Physician Global Assessment (PGA) of Disease Activity at Month 9 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | Month 9 |
| Physician Global Assessment (PGA) of Disease Activity at Month 12 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | Month 12 |
| Visual Analogue Scale for Pain (VAS-pain) at Month 3 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | Month 3 |
| Visual Analogue Scale for Pain (VAS-pain) at Month 6 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | Month 6 |
| Visual Analogue Scale for Pain (VAS-pain) at Month 9 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | Month 9 |
| Visual Analogue Scale for Pain (VAS-pain) at Month 12 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | Month 12 |
| C-reactive Protein (CRP) at Month 3 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | Month 3 |
| C-reactive Protein (CRP) at Month 6 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | Month 6 |
| C-reactive Protein (CRP) at Month 9 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | Month 9 |
| C-reactive Protein (CRP) at Month 12 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | Month 12 |
| Erythrocyte Sedimentation Rate (ESR) at Month 3 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | Month 3 |
| Erythrocyte Sedimentation Rate (ESR) at Month 6 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | Month 6 |
| Erythrocyte Sedimentation Rate (ESR) at Month 9 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | Month 9 |
| Erythrocyte Sedimentation Rate (ESR) at Month 12 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | Month 12 |
| Number of Participants With Rheumatoid Factor (RF) at Month 3 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | Month 3 |
| Number of Participants With Rheumatoid Factor (RF) at Month 6 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | Month 6 |
| Number of Participants With Rheumatoid Factor (RF) at Month 9 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | Month 9 |
| Number of Participants With Rheumatoid Factor (RF) at Month 12 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | Month 12 |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | Month 3 |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | Month 6 |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | Month 9 |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | Month 12 |
| Number of Participants With Anti-nuclear Antibodies at Month 3 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | Month 3 |
| Number of Participants With Anti-nuclear Antibodies at Month 6 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | Month 6 |
| Number of Participants With Anti-nuclear Antibodies at Month 9 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | Month 9 |
| Number of Participants With Anti-nuclear Antibodies at Month 12 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | Month 12 |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | Month 3 |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | Month 6 |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | Month 9 |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | Month 12 |
| Duration of Morning Stiffness at Month 3 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Month 3 |
| Duration of Morning Stiffness at Month 6 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Month 6 |
| Duration of Morning Stiffness at Month 9 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Month 9 |
| Duration of Morning Stiffness at Month 12 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Month 12 |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 3 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | Month 3 |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 6 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | Month 6 |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 9 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | Month 9 |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 12 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | Month 12 |
| 36-Item Short-Form Health Survey (SF-36) at Month 12 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Month 12 |
| Baseline, Months 3, 6, 9 and 12 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Percentage of participants with Disease Activity Score Based on 28-joints count (DAS28) remission | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the ESR and PtGA of disease activity. DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6. | Number | Percentage of participants |
|
| Disease Activity Score Based on 28-joints count (DAS28) | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR and PtGA of disease activity. DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Number of participants analyzed (N)=272 for this parameter. | Mean | Standard Deviation | Units on a scale |
|
| Patient Global Assessment (PtGA) | PtGA measured using a 10 cm Visual Analog Scale (VAS) ranging from 0 cm = very good to 10 cm = very bad. | Mean | Standard Deviation | centimeter (cm) |
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| Physician Global Assessment (PGA) | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | Mean | Standard Deviation | cm |
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| Visual Analogue Scale for Pain (VAS-pain) | 10 cm line (VAS) marked by participant. Intensity of pain range: 0 cm = no pain to 10 cm = worst possible pain. | Mean | Standard Deviation | cm |
|
| C-reactive Protein (CRP) | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. Number of participants analyzed (N) = 272 for this parameter. | Mean | Standard Deviation | milligram/deciliter (mg/dL) |
|
| Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | Mean | Standard Deviation | millimeter/hour (mm/hr) |
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| Rheumatoid Factor (RF) | RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 unit/milliliter (U/mL) is considered positive. | Number | Participants |
|
| Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | Number | Participants |
|
| Anti-nuclear antibodies | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | Number | Participants |
|
| Anti-deoxyribonucleic Acid (Anti-DNA) antibodies | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | Number | Participants |
|
| Duration of morning stiffness | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Mean | Standard Deviation | minutes |
|
| Stanford Health Assessment Questionnaire (HAQ) | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Average score range: 0 to 3. | Mean | Standard Deviation | Units on a scale |
|
| 36-Item Short-Form Health Survey (SF-36) | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Mean | Standard Deviation | Units on a Scale |
|
| Disease duration | Median | Inter-Quartile Range | Years |
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| Number of tender joints | The mean number of tender joints was evaluated based on the number of tender joints in a standard 28 joint count. | Mean | Standard Deviation | Tender joints |
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| Number of swollen joints (SJC) | The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 28 joint count. | Mean | Standard Deviation | Swollen joints |
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| Percentage of participants given Disease Modifying Anti-Rheumatoid Drugs (DMARD) | Number | Percentage of participants |
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| Primary | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Percentage of participants | Month 6 |
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| Primary | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Percentage of participants | Month 9 |
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| Primary | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF). | Posted | Number | Percentage of participants | Month 12 |
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| Primary | Disease Activity Score Based on 28-joints Count (DAS28) at Month 3 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Month 3 |
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| Primary | Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Month 6 |
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| Primary | Disease Activity Score Based on 28-joints Count (DAS28) at Month 9 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Month 9 |
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| Primary | Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | Units on a Scale | Month 12 |
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| Primary | Patient Global Assessment (PtGA) of Disease Activity Score at Month 3 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 3 |
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| Primary | Patient Global Assessment (PtGA) of Disease Activity Score at Month 6 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 6 |
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| Primary | Patient Global Assessment (PtGA) of Disease Activity Score at Month 9 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 9 |
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| Primary | Patient Global Assessment (PtGA) of Disease Activity Score at Month 12 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | cm | Month 12 |
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| Primary | Physician Global Assessment (PGA) of Disease Activity at Month 3 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 3 |
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| Primary | Physician Global Assessment (PGA) of Disease Activity at Month 6 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 6 |
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| Primary | Physician Global Assessment (PGA) of Disease Activity at Month 9 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 9 |
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| Primary | Physician Global Assessment (PGA) of Disease Activity at Month 12 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | cm | Month 12 |
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| Primary | Visual Analogue Scale for Pain (VAS-pain) at Month 3 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 3 |
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| Primary | Visual Analogue Scale for Pain (VAS-pain) at Month 6 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 6 |
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| Primary | Visual Analogue Scale for Pain (VAS-pain) at Month 9 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | cm | Month 9 |
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| Primary | Visual Analogue Scale for Pain (VAS-pain) at Month 12 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | cm | Month 12 |
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| Primary | C-reactive Protein (CRP) at Month 3 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | mg/dL | Month 3 |
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| Primary | C-reactive Protein (CRP) at Month 6 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | mg/dL | Month 6 |
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| Primary | C-reactive Protein (CRP) at Month 9 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | mg/dL | Month 9 |
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| Primary | C-reactive Protein (CRP) at Month 12 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | mg/dL | Month 12 |
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| Primary | Erythrocyte Sedimentation Rate (ESR) at Month 3 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | mm/hr | Month 3 |
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| Primary | Erythrocyte Sedimentation Rate (ESR) at Month 6 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | mm/hr | Month 6 |
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| Primary | Erythrocyte Sedimentation Rate (ESR) at Month 9 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | mm/hr | Month 9 |
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| Primary | Erythrocyte Sedimentation Rate (ESR) at Month 12 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | mm/hr | Month 12 |
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| Primary | Number of Participants With Rheumatoid Factor (RF) at Month 3 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 3 |
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| Primary | Number of Participants With Rheumatoid Factor (RF) at Month 6 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 6 |
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| Primary | Number of Participants With Rheumatoid Factor (RF) at Month 9 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 9 |
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| Primary | Number of Participants With Rheumatoid Factor (RF) at Month 12 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Number | Participants | Month 12 |
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| Primary | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 3 |
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| Primary | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 6 |
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| Primary | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 9 |
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| Primary | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Number | Participants | Month 12 |
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| Primary | Number of Participants With Anti-nuclear Antibodies at Month 3 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 3 |
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| Primary | Number of Participants With Anti-nuclear Antibodies at Month 6 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 6 |
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| Primary | Number of Participants With Anti-nuclear Antibodies at Month 9 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 9 |
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| Primary | Number of Participants With Anti-nuclear Antibodies at Month 12 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Number | Participants | Month 12 |
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| Primary | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 3 |
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| Primary | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 6 |
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| Primary | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Number | Participants | Month 9 |
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| Primary | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Number | Participants | Month 12 |
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| Primary | Duration of Morning Stiffness at Month 3 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | minutes | Month 3 |
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| Primary | Duration of Morning Stiffness at Month 6 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | minutes | Month 6 |
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| Primary | Duration of Morning Stiffness at Month 9 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | minutes | Month 9 |
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| Primary | Duration of Morning Stiffness at Month 12 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | minutes | Month 12 |
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| Primary | Stanford Health Assessment Questionnaire (HAQ) Score at Month 3 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Month 3 |
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| Primary | Stanford Health Assessment Questionnaire (HAQ) Score at Month 6 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Month 6 |
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| Primary | Stanford Health Assessment Questionnaire (HAQ) Score at Month 9 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | ITT population included all participants who received at least 1 dose of the study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Month 9 |
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| Primary | Stanford Health Assessment Questionnaire (HAQ) Score at Month 12 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | Units on a Scale | Month 12 |
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| Primary | 36-Item Short-Form Health Survey (SF-36) at Month 12 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF. | Posted | Mean | Standard Deviation | Units on a Scale | Month 12 |
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| Secondary | Direct Costs | Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability. | There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure. | Posted | Baseline, Months 3, 6, 9 and 12 |
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| Secondary | Indirect Costs | Indirect costs represent the loss of resources as a consequence of work disability or unemployment. | There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure. | Posted | Baseline, Months 3, 6, 9 and 12 |
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| 0 |
| 272 |
| 21 |
| 272 |
| Bronchopulmonary infection | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Blood pressure high | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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