At a glance
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A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
In Brief
A Phase 2 clinical trial evaluating Rituximab, Methotrexate, and 5 other interventions for Rheumatoid Arthritis. Completed, enrolled 103 participants across 34 sites.
Detailed Summary
This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
Study Details
Timeline
Interventions
Rituximab was supplied in single-use vials.
Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.
Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.
Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.
Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)