At a glance
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An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
In Brief
A Phase 4 clinical trial evaluating rituximab [MabThera/Rituxan], methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 18 participants across 4 sites.
Detailed Summary
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50
Study Details
Timeline
Interventions
1000 mg iv infusion on days 1 and 15
10-25 mg weekly (oral or parenteral)
100 mg iv prior to each rituximab infusion