A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies

This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients, 18-80 years of age;
• rheumatoid arthritis for >=6 months;
• receiving outpatient treatment;
• an inadequate response to at least one anti-TNF therapy;
• stable methotrexate for >=12 weeks.

Exclusion Criteria:

• other rheumatic autoimmune disease or inflammatory joint disease;
• previous treatment with MabThera;
• concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.