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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Research Site
Winnipeg, Manitoba, Canada
Research Site
Quispamsis, New Brunswick, Canada
Research Site
Toronto, Ontario, Canada
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
Time frame: Week 12
Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study
Time frame: 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
Time frame: Week 12
Proportion of subjects achieving ACR50 and ACR70 response
Time frame: Week 12
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