Conditions: Systemic Lupus Erythematosus
Keywords: Autoimmune Diseases Lupus SLE Systemic Lupus Erythematosus Belimumab Antibodies
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 865
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 Week 48. intervention 2: Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48. intervention 3: Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.

Protocol document: