A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid
arthritis (RA), there is still a significant unmet medical need for the treatment of
subjects with this chronic disease to achieve a faster, more complete response, and higher
rates of remission. The aim of the current study is to compare the efficacy and safety of a
subcutaneous dose of mavrilimumab with a marketed treatment for RA (golimumab) in 120 adult
subjects with moderate-to-severe active RA who have had an inadequate response to one or two
anti-TNF agents with mavrilimumab
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of subjects who achieve American College of Rheumatology 20%/50%/70% improvement
Also included in the primary outcome measure are: disease activity score in 28 joints (DAS28) < 2.6, and Health Assessment Questionnaire Disability Index (HAQ-DI) improvement > 0.25
24 Weeks
No
United States: Food and Drug Administration
CD-IA-CAM-3001-1107
NCT01715896
March 2013
October 2015
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