A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, 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;

• RA for >=6 months;

• receiving outpatient treatment;

• inadequate response to methotrexate, having received and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.

Exclusion Criteria:

• rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;

• inflammatory joint disease other than RA, or other systemic autoimmune disorder;

• diagnosis of juvenile arthritis, or RA before the age of 16;

• previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.