Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of 3 different doses of
      belimumab, administered in addition to standard therapy, in patients with active SLE disease.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of three different doses of
      belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy,
      compared to placebo plus standard therapy in patients with active SLE disease. Patients were
      randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7
      versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy
      for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the
      remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week
      open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg
      at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
    

Intervention name(s): Placebo; Belimumab 1 mg/kg; Belimumab 4 mg/kg; Belimumab 10 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.; Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.; Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.; Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
Other intervention name(s): LymphoStat-B®; BENLYSTA®; LymphoStat-B®; BENLYSTA®; LymphoStat-B®; BENLYSTA®
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SLE