A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Inclusion Criteria:

• adult patients, 18-80 years of age;
• rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
• active disease;
• DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Exclusion Criteria:

• autoimmune disease other than rheumatoid arthritis;
• bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
• concurrent treatment with any DMARD or antiTNF-alfa;
• intra-articular or parenteral corticosteroids within 4 weeks prior to screening.