Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 378
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: rituximab [MabThera/Rituxan] intervention 3: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 500mg iv in days 1 and 15, and 500mg iv on days 168 and 182 intervention 2: 500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182 intervention 3: 1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182

Protocol document: