Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

Prior treatment

• 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 had a major organ transplant.
• Have a planned surgical procedure.
• Have current drug or alcohol abuse or dependence.

Other illness

• Have severe lupus kidney disease.
• Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
• History of malignant neoplasm within the last 5 years.
• Have required management of acute or chronic infections in the past 60 days.
• Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.

Lab values

• Have severe laboratory abnormalities.

Other

• Pregnant or nursing.
• Have active central nervous system (CNS) lupus.
• Have an IgA deficiency.
• 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.

• 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