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Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Background Therapy | Placebo Comparator | Background therapy including DMARD(s) approved by protocol |
|
| BIIB057 Dose 1 + Background Therapy | Experimental | Background therapy including DMARD(s) approved by protocol |
|
| BIIB057 Dose 2 + Background Therapy | Experimental | Background therapy including DMARD(s) approved by protocol |
|
| BIIB057 Dose 3 + Background Therapy | Experimental | Background therapy including DMARD(s) approved by protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB057 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study | Up to 16 weeks | |
| Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Winnipeg | Manitoba | R3C 3J5 | Canada | ||
| Research Site |
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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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| Placebo | Drug | Oral |
|
| Week 12 |
| Proportion of subjects achieving ACR50 and ACR70 response | Week 12 |
| Quispamsis |
| New Brunswick |
| E2E 4J8 |
| Canada |
| Research Site | Toronto | Ontario | M9W 4L6 | Canada |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |