A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

• Status: Completed
• Trial end date: 2009-03-12
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients, 18-80 years of age

• Moderate to severe active rheumatoid arthritis

• Inadequate response to a single previous or current treatment with an anti-TNF agent

• Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

Exclusion Criteria:

• Previous treatment with MabThera

• Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)

• Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate

• Active infection, or history of serious or chronic infection