At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of RA for at least 6 months
- ✓Inadequate response to methotrexate
- ✓Currently using folate supplementation
- ✓If female and childbearing potential, negative serum pregnancy test within 8 weeks of first infusion
- ✕Diagnosis before age 16 or juvenile idiopathic arthritis (juvenile RA)
- ✕Inflammatory arthritis other than RA (e.g., IBD, SLE, psoriatic arthritis)
- ✕Functional Class IV per ACR classification
- ✕Previous rituximab treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate
In Brief
A Phase 2 clinical trial evaluating folate, methotrexate, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 42 participants.
Detailed Summary
This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).
Study Details
Timeline
Interventions
Minimum of 1 mg/day oral (or folinic acid 5 mg/week)
15-25 mg/week oral or parenteral (10-14 mg/week if intolerant)
100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion)
To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.
500 mg or 1000 mg IV\*2.