At a glance
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A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis
In Brief
A Phase 4 clinical trial evaluating rituximab, methotrexate, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 351 participants across 86 sites.
Detailed Summary
This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.
Study Details
Timeline
Interventions
1000 mg in 250 mL intravenous infusion
10 to 25 mg/week (oral or parenteral)
100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion
1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion