Conditions: Systemic Lupus Erythematosus
Keywords: Antibodies Autoimmune Diseases Systemic Lupus Erythematosus SLE Belimumab Lupus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 819
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Detailed description:

Arms:
arm 1: Placebo arm 2: Belimumab 1 mg/kg arm 3: Belimumab 10 mg/kg

Interventions: intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 10 mg/kg
Intervention descriptions: intervention 1: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. intervention 3: Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Protocol document: