Conditions: Lupus Erythematosus, Systemic
Keywords: Rituxan SLE Lupus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 262
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. arm 2: Participants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.

Interventions: intervention 1: Rituximab intervention 2: Placebo intervention 3: Prednisone intervention 4: Acetaminophen intervention 5: Diphenhydramine
Intervention descriptions: intervention 1: Rituximab will be supplied as a sterile liquid for IV administration. intervention 2: Placebo will be supplied as a sterile liquid for IV administration. intervention 3: None intervention 4: None intervention 5: None

Protocol document: