GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab; Placebo
Intervention description: 10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.; Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLEDAI; Asia; placebo; BLys; PGA; BILAG; systemic lupus erythematosus; SELENA; Lupus; SRI; efficacy; B cell; SLE Flare Index; belimumab; safety; phase III; B lymphocyte

Summary:

      The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to
      standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus
      erythematosus (SLE) over a 52 week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older.

          -  Have a clinical diagnosis of SLE according to the American College of Rheumatology
             (ACR) classification criteria.

          -  Have active SLE disease.

          -  Have positive anti-nuclear antibody (ANA) test results.

          -  Are on a stable SLE treatment regimen.

          -  Females of childbearing age are willing to use appropriate contraception

        Exclusion Criteria:

          -  Have received treatment with any B cell targeted therapy at any time.

          -  Have received a biologic investigational agent in the past year.

          -  Have received 3 or more courses of systemic corticosteroids in the past year.

          -  Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.

          -  Have severe lupus kidney disease.

          -  Have active central nervous system (CNS) lupus.

          -  Have had a major organ transplant.

          -  Have significant unstable or uncontrolled acute or chronic diseases or conditions not
             due to SLE.

          -  Have a planned surgical procedure.

          -  Cancer within the last 5 years, except for adequately treated skin cancer, or
             carcinoma in situ of the uterine cervix.

          -  Have required management of acute or chronic infections in the past 60 days.

          -  Have current drug or alcohol abuse or dependence.

          -  Have a historically positive test, or test positive at screening for HIV, Hepatitis B,
             or Hepatitis C.

          -  Have an IgA deficiency.

          -  Have severe laboratory Abnormalities.

          -  Have had anaphylactic reaction to X-ray contrast agents or biologic agents.

          -  Suicidal behavior or ideation.