A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Belimumab 1 mg/kg; Belimumab 4 mg/kg; Belimumab 10 mg/kg
Intervention description: Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 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 RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 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 RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 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 RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of 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: 283.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: RA

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 rheumatoid
      arthritis (RA).
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Diagnosis of RA for at least 1 year

          -  Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or
             lack of efficacy. These drugs must include 1 or more of the following: methotrexate,
             parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα)
             inhibitors (infliximab, etanercept or adalimumab)

          -  Active RA disease of at least moderate disease activity

          -  Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on
             non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable
             dose for the last 30 days

        Primary Exclusion Criteria:

          -  Received a non-FDA approved investigational agent within the last 28 days

          -  Currently receiving or received within the last 60 days the following: TNFα-inhibitors
             (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)

          -  Currently receiving or received within the last 6 months the following: anti-CD20
             antibody (rituximab) or cyclophosphamide

          -  Steroid injection into any joint within the last 30 days

          -  History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency

          -  History of chronic infection that has been active within last 6 months, or herpes
             zoster within last 90 days, or any infection requiring hospitalization or intravenous
             medication within last 60 days

          -  Human immunodeficiency virus (HIV), Hepatitis-B, Hepatitis-C