Conditions: Systemic Lupus Erythematosus
Keywords: Lupus Monoclonal antibody B-Cell immunotherapy Epratuzumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1250
Healthy volunteers: no

Brief summary:
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Detailed description:
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

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

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

Protocol document: