Conditions: Rheumatoid Arthritis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 341
Healthy volunteers: no

Brief summary:
This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: methotrexate intervention 2: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: a 10-25 mg stable dose given orally or parenterally throughout study intervention 2: 1 g given by intravenous infusion on Days 1 and 15 of each treatment course

Protocol document: