At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with RA for at least 1 year
- ✓Failed at least 1 DMARD (methotrexate, parenteral gold, sulfasalazine, leflunomide, or TNFα inhibitor) due to toxicity or lack of efficacy
- ✓Active RA with at least moderate disease activity
- ✓On stable RA treatment regimen for ≥60 days (DMARDs) or ≥30 days (NSAIDs/steroids)
- ✕Received non-FDA approved investigational agent within 28 days
- ✕Currently receiving or received TNFα inhibitors or anakinra within 60 days
- ✕Currently receiving or received anti-CD20 antibody (rituximab) or cyclophosphamide within 6 months
- ✕Steroid injection into any joint within 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
In Brief
A Phase 2 clinical trial evaluating Placebo, Belimumab 1 mg/kg, and 2 other interventions for Arthritis, Rheumatoid. Completed, enrolled 283 participants across 63 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).
Study Details
Timeline
Interventions
Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.