A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

• Status: Completed
• Trial end date: 2007-11-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

Inclusion Criteria:

• adult patients, 18-80 years of age;

• rheumatoid arthritis after inadequate response to >=1 DMARD treatment;

• active disease;

• DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Exclusion Criteria:

• autoimmune disease other than rheumatoid arthritis;

• bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;

• concurrent treatment with any DMARD or antiTNF-alfa;

• intra-articular or parenteral corticosteroids within 4 weeks prior to screening.