At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of systemic lupus erythematosus (SLE)
- ✓Evidence of active disease at screening
- ✓Currently on stable dose of one immunosuppressive drug
- ✓Currently using an antimalarial drug
- ✕Active moderate to severe glomerulonephritis
- ✕Active severe CNS manifestations of SLE (retinitis, poorly controlled seizures, acute confusion, myelitis, stroke, cerebellar ataxia, or dementia)
- ✕HIV infection
- ✕Active infection of any kind (excluding fungal nail infections) or recent major infection requiring hospitalization or IV antibiotics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
In Brief
A Phase 3 clinical trial evaluating Rituximab, Placebo, and 3 other interventions for Lupus Erythematosus, Systemic. Completed, enrolled 262 participants across 65 sites in 2 countries.
Detailed Summary
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
Study Details
Timeline
Interventions
Rituximab will be supplied as a sterile liquid for IV administration.
Placebo will be supplied as a sterile liquid for IV administration.