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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. 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. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate; Rituximab

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• active rheumatoid arthritis;

• receiving outpatient treatment;

• an inadequate response, or intolerance, to >=1 anti-TNF agent.

Exclusion Criteria:

• other rheumatic autoimmune disease or inflammatory joint disease;

• concurrent treatment with any anti-TNF-alpha therapy;

• joint or osseous surgery during 8 weeks prior to recruitment.