Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Belimumab 1 mg/kg; Belimumab 4 mg/kg; Belimumab 10 mg/kg
Intervention description: 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.
Intervention MeSH terms: Belimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: SLE

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.
    

Eligibility criteria:

        Primary Inclusion Criteria

          -  Clinical diagnosis of SLE

          -  "Active" SLE disease

          -  On a stable SLE treatment regimen

          -  History of measurable autoantibodies

        Primary Exclusion Criteria

          -  Received a non-FDA approved investigational agent within last 28 days

          -  Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days

          -  Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or
             high-dose prednisone (> 100 mg/day) within last 90 days

          -  Active central nervous system (CNS) lupus requiring therapeutic intervention within
             last 60 days

          -  History of renal transplant

          -  History of chronic infection that has been active within last 6 months, herpes zoster
             within last 90 days or any infection requiring hospitalization or intravenous
             medication within last 60 days

          -  History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency

          -  Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C