At a glance
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An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies
In Brief
A Phase 4 clinical trial evaluating rituximab, Methotrexate, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 40 participants across 4 sites.
Detailed Summary
This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
1000 mg i.v. on Days 1 and 15
10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24
≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24
≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24