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This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra] | Drug | tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death | Baseline, every 4 weeks through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28) | DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; 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 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sfax | 3000 | Tunisia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the European League Against Rheumatism (EULAR) category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Phase |
|
| ||||||||||||||||||||||||
| Extension Phase |
|
Safety population: All participants who received at least one dose of medication and for whom at least one post baseline safety measurement was available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28) | DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; 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 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement. | Safety population; number (n)= number of participants analyzed at a specific visit | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
AEs were recorded from the date of first infusion until the end of study at 52 weeks.
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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 | Tocilizumab | Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusional syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral ulcer | Infections and infestations | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
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| Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Percentage of Participants Achieving LDA Assessed Using DAS28 | DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA. | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Percentage of Participants Achieving Remission Assessed Using DAS28 | DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) | The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit. | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Time To Achieve ACR20/ACR50/ACR70 | The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates. | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| SJC and TJC | 28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Assessment of Pain by the Participant Using Visual Analog Scale (VAS) | The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to their level of pain and the distance from the left edge was measured. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Assessment of Global Disease by the Participant Using VAS | The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS) | The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Assessment of Physical Function Using Health Assessment Questionnaire (HAQ) | Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Mean C-Reactive Protein (CRP) Levels | CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L). | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Mean Erythrocyte Sedimentation Rate (ESR) Levels | ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
| Percentage of Participants Experiencing Fatigue | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
| Number of Participants Who Discontinued Tocilizumab | Week 52 |
| Sousse |
| 4000 |
| Tunisia |
| Tunis | 1007 | Tunisia |
| Tunis | 1008 | Tunisia |
| Tunis | 2010 | Tunisia |
| Tunis | 2046 | Tunisia |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Tocilizumab |
Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks. |
|
|
| Secondary | Percentage of Participants Achieving LDA Assessed Using DAS28 | DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA. | Safety population; n=number of participants analyzed at a specific visit | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Percentage of Participants Achieving Remission Assessed Using DAS28 | DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6. | Safety population; n=number of participants analyzed at a specific visit | Posted | Number | percentage of participants | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) | The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit. | Safety population | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Time To Achieve ACR20/ACR50/ACR70 | The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates. | Safety population | Posted | Median | Inter-Quartile Range | weeks | Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | SJC and TJC | 28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each. | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | joints | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Assessment of Pain by the Participant Using Visual Analog Scale (VAS) | The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to their level of pain and the distance from the left edge was measured. | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | mm | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Assessment of Global Disease by the Participant Using VAS | The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured. | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | mm | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS) | The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured. | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | mm | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Assessment of Physical Function Using Health Assessment Questionnaire (HAQ) | Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities. | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Mean C-Reactive Protein (CRP) Levels | CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L). | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | mg/L | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Mean Erythrocyte Sedimentation Rate (ESR) Levels | ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour. | Safety population; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | Mean | 95% Confidence Interval | mm/hour | Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52 |
|
|
|
| Secondary | Percentage of Participants Experiencing Fatigue | Safety population; n=number of participants analyzed for the given parameter at the specified visit | Posted | Number | percentage of participants | Baseline and Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Primary | Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death | Safety population | Posted | Number | percentage of participants | Baseline, every 4 weeks through Week 52 |
|
|
|
| Secondary | Number of Participants Who Discontinued Tocilizumab | Safety population | Posted | Number | participants | Week 52 |
|
|
|
| 3 |
| 51 |
| 39 |
| 51 |
| Whitlows of the toe | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Pleural-pneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Acute appendicitis | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Osteoarticular fracture (fifth metatarsal) | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteomalacia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin and subcutaneous lesions | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Flu syndrome | General disorders | MedDRA | Non-systematic Assessment |
|
| Urinary infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
|
| Increased ALT/AST | Investigations | MedDRA | Non-systematic Assessment |
|
| Hypercholesterolemia | Investigations | MedDRA | Non-systematic Assessment |
|
| Hypertriglyceridemia | Investigations | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Investigations | MedDRA | Non-systematic Assessment |
|
| Cytolysis | Investigations | MedDRA | Non-systematic Assessment |
|
| Reticulocytosis | Investigations | MedDRA | Non-systematic Assessment |
|
| Oral thrush | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Headache | General disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Erythematous plaque of Elbows | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hiatal hernia esopahgitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Erythematous purpuric lesions | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Papular skin lesions | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hyperbilirubinemai | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Lower gastrointestinal bleeding - Hemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vasodilation of feet | General disorders | MedDRA | Non-systematic Assessment |
|
| Hyperisonophilia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Hypokalemia | General disorders | MedDRA | Non-systematic Assessment |
|
| Hallux Abscess | General disorders | MedDRA | Non-systematic Assessment |
|
| Bronchial Infectious syndrome | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Week 16 (n=47) |
|
| Week 20 (n=46) |
|
| Week 24 (n=46) |
|
| Week 36 (n=43) |
|
| Week 48 (n=41) |
|
| Week 52 (n=42) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=47) |
|
| Week 20 (n=46) |
|
| Week 24 (n=46) |
|
| Week 36 (n=43) |
|
| Week 48 (n=41) |
|
| Week 52 (n=42) |
|
| Title | Measurements |
|---|---|
|
| Week 8 ACR20 |
|
| Week 8 ACR50 |
|
| Week 8 ACR70 |
|
| Week 12 ACR20 |
|
| Week 12 ACR50 |
|
| Week 12 ACR70 |
|
| Week 16 ACR20 |
|
| Week 16 ACR50 |
|
| Week 16 ACR70 |
|
| Week 20 ACR20 |
|
| Week 20 ACR50 |
|
| Week 20 ACR70 |
|
| Week 24 ACR20 |
|
| Week 24 ACR50 |
|
| Week 24 ACR70 |
|
| Week 36 ACR20 |
|
| Week 36 ACR50 |
|
| Week 36 ACR70 |
|
| Week 48 ACR20 |
|
| Week 48 ACR50 |
|
| Week 48 ACR70 |
|
| Week 52 ACR20 |
|
| Week 52 ACR50 |
|
| Week 52 ACR70 |
|
|
| Title | Measurements |
|---|---|
|
| Week 4 SJC (n=51) |
|
| Week 8 TJC (n=46) |
|
| Week 8 SJC (n=49) |
|
| Week 12 TJC (n=47) |
|
| Week 12 SJC (n=47) |
|
| Week 16 TJC (n=47) |
|
| Week 16 SJC (n=47) |
|
| Week 20 TJC (n=46) |
|
| Week 20 SJC (n=46) |
|
| Week 24 TJC (n=46) |
|
| Week 24 SJC (n=46) |
|
| Week 28 TJC (n=34) |
|
| Week 28 SJC (n=34) |
|
| Week 32 TJC (n=34) |
|
| Week 32 SJC (n=34) |
|
| Week 36 TJC (n=41) |
|
| Week 36 SJC (n=41) |
|
| Week 40 TJC (n=33) |
|
| Week 40 SJC (n=33) |
|
| Week 44 TJC (n=34) |
|
| Week 44 SJC (n=34) |
|
| Week 48 TJC (n=39) |
|
| Week 48 SJC (n=39) |
|
| Week 52 TJC (n=40) |
|
| Week 52 SJC (n=40) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=48) |
|
| Week 20 (n=45) |
|
| Week 24 (n=46) |
|
| Week 36 (n=44) |
|
| Week 48 (n=41) |
|
| Week 52 (n=40) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=48) |
|
| Week 20 (n=45) |
|
| Week 24 (n=46) |
|
| Week 36 (n=44) |
|
| Week 48 (n=41) |
|
| Week 52 (n=41) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=48) |
|
| Week 20 (n=45) |
|
| Week 24 (n=46) |
|
| Week 36 (n=44) |
|
| Week 48 (n=41) |
|
| Week 52 (n=40) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=48) |
|
| Week 20 (n=46) |
|
| Week 24 (n=46) |
|
| Week 36 (n=40) |
|
| Week 48 (n=37) |
|
| Week 52 (n=38) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=46) |
|
| Week 20 (n=46) |
|
| Week 24 (n=44) |
|
| Week 36 (n=43) |
|
| Week 48 (n=42) |
|
| Week 52 (n=40) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=47) |
|
| Week 16 (n=47) |
|
| Week 20 (n=46) |
|
| Week 24 (n=46) |
|
| Week 36 (n=43) |
|
| Week 48 (n=42) |
|
| Week 52 (n=42) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=45) |
|
| Week 16 (n=47) |
|
| Week 20 (n=44) |
|
| Week 24 (n=46) |
|
| Title | Measurements |
|---|
|
| Discontinuation due to AE |
|
| Death |
|