Resumen

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

Descripción detallada

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 (SELENA SLEDAI score ≥ 6). The study will consist of three phases: a 52-week randomized, placebo-controlled, double-blind phase; a long term open label continuation phase; and a long term safety follow up phase. The long term open label continuation and safety follow up periods will continue for at least 5 years and possibly up to 10 years from a subject's initial treatment with belimumab. Enrolment will be staggered by age cohorts to allow safety and PK interim analyses. Subjects will be randomized to belimumab 10mg/kg or placebo IV monthly dosing while continuing to receive background standard therapy throughout the study. An independent data monitoring committee (IDMC) will monitor the study as it progresses.

Elegibilidad

Edad mínima: 5 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

belimumab 10mg/kg

placebo

Ubicaciones

GSK Investigational Site

GSK Investigational Site

Patrocinadores