Conditions: Systemic Lupus Erythematosus
Keywords: Lupus Monoclonal antibody B-Cell immunotherapy Epratuzumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 791
Healthy volunteers: no

Brief summary:
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Detailed description:

Arms:
arm 1: Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles arm 2: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles arm 3: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles

Interventions: intervention 1: Placebo intervention 2: Epratuzumab intervention 3: Epratuzumab
Intervention descriptions: intervention 1: Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles intervention 2: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles intervention 3: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Protocol document: