Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: belimumab 10mg/kg; placebo
Intervention description: belimumab 10mg/kg IV monthly; Normal Saline 250 ml
Intervention MeSH terms: Belimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: SLE Flare Index; SRI; belimumab; efficacy; safety; B lymphocyte; BLyS; SELENA SLEDAI; BILAG; Lupus; Systemic Lupus Erythematosus (SLE); PGA; Pharmacokinetics; placebo; PRINTO

Summary:

      This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of
      belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic
      lupus erythematosus
    

Eligibility criteria:

        Inclusion Criteria:

          -  5 years to 17 years of age at enrollment

          -  Have a clinical diagnosis of SLE according to the American College of Rheumatology
             (ACR) classification criteria.

          -  Have active SLE disease (SELENA SLEDAI score ≥ 6).

          -  Have positive anti-nuclear antibody (ANA) test results.

          -  Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days
             prior to Day 0.

          -  Females of childbearing age are willing to use appropriate contraception

          -  Subject age appropriate assent and parent or legal guardian informed consent to
             participate

        Exclusion Criteria:

          -  Pregnant or nursing.

          -  Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a
             registered trademark of the GSK group of companies.)

          -  Treatment with any B cell targeted therapy (for example, rituximab) or an
             investigational biological agent in the past year.

          -  Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or
             plasmapheresis within 90 days of Day 0.

          -  Have received high dose prednisone or equivalent (>1.5mg/kg/day) within 60 days of
             baseline.

          -  Have received intravenous (IV) cyclophosphamide within 60 days of Day 0.

          -  Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent
             within 60 days of baseline.

          -  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.

          -  History of malignant neoplasm within the last 5 years.

          -  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.

          -  Children in Care(CiC): a child who has been placed under the control or protection of
             an agency, organisation, institution or entity by the courts, the government or a
             government body, acting in accordance with powers conferred on them by law or
             regulation.