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Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

NCT01649765

CompletedPhase 2

Sponsor: GlaxoSmithKline

Conditions: Systemic Lupus Erythematosus

Interventions: Belimumab 10 mg/kg, Placebo

Countries: United States, Argentina, Canada, Japan, Mexico, Peru, Poland, Russia

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 overview

Sex: ALL

Age: 5 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (32)
  • Phoenix, Arizona, United States
  • Washington D.C., District of Columbia, United States
  • Augusta, Georgia, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Cincinnati, Ohio, United States
  • Buenos Aires, Argentina
  • Rosario, Argentina
  • Santa Fe, Argentina
  • Calgary, Alberta, Canada
  • Toronto, Ontario, Canada
  • Aichi, Japan
  • Kagoshima, Japan
  • Miyagi, Japan
  • Tokyo, Japan
  • San Luis Potosí City, Mexico
  • Lima, Peru
  • Lima, Peru
  • Surco, Peru
  • Lodz, Poland
  • Warsaw, Poland
  • Moscow, Russia
  • Saint Petersburg, Russia
  • Tolyatti, Russia
  • Espluges de Llobregat, Spain
  • Madrid, Spain
  • Valencia, Spain
  • Bristol, United Kingdom
  • Liverpool, United Kingdom
  • + 2 more on CT.gov