A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• rheumatoid arthritis >=6 months;

• lack of response to 1-5 DMARDs or biological agents;

• rheumatoid factor positive.

Exclusion Criteria:

• other chronic inflammatory articular disease or systemic rheumatic disease;

• joint or bone surgery during 8 weeks prior to randomization;

• previous treatment with any cell-depleting therapy.