Conditions: Systemic Lupus Erythematosus
Keywords: SLEDAI Asia placebo BLys PGA BILAG systemic lupus erythematosus SELENA Lupus SRI efficacy B cell SLE Flare Index belimumab safety phase III B lymphocyte
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 709
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

Detailed description:
The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

Arms:
arm 1: 10mg/kg arm 2: placebo

Interventions: intervention 1: Belimumab intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study. intervention 2: Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Protocol document: