A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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.