At a glance
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A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate
In Brief
A Phase 3 clinical trial evaluating Rituximab, Placebo, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 185 participants across 60 sites in 19 countries.
Detailed Summary
This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.
Study Details
Timeline
Interventions
Rituximab was supplied as a sterile liquid for iv administration.
Placebo was supplied as a sterile liquid in single-use vials for iv administration.