SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. 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: Rituximab

Criteria

Inclusion Criteria:

• Adult patients >18 years of age

• RA for >=6 months

• Receiving outpatient treatment

• Ongoing treatment with methotrexate for >=3 months, stable for >=1 month

• Inadequate response or intolerance to etanercept, infliximab or adalimumab

Exclusion Criteria:

• Previous treatment with MabThera

• Concurrent treatment with any anti TNF-alfa therapy or biologic therapy

• Previous treatment with any investigational cell-depleting therapies