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A phase III, multi-center, multi-national, randomized withdrawal study to evaluate the safety and efficacy of BMS-188667 [abatacept] in children and adolescents with active polyarticular juvenile rheumatoid arthritis.

Trial Profile

A phase III, multi-center, multi-national, randomized withdrawal study to evaluate the safety and efficacy of BMS-188667 [abatacept] in children and adolescents with active polyarticular juvenile rheumatoid arthritis.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2022

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At a glance

  • Drugs Abatacept (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms AWAKEN; JIA-1
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 04 Jun 2022 Results (n=347) of an analysis assessing predictors of clinical response to abatacept in children with polyarticular juvenile idiopathic arthritis; using data from two phase 3 clinical studies: JIA-1 (2-17years; SC administration) and JIA-2 (6-17years; IV administration) presented at the 23rd Annual Congress of the European League Against Rheumatism
    • 15 Jan 2021 Results assessing the relationship between infection risk and abatacept exposure levels in patients with polyarticular-course juvenile idiopathic arthritis (pJIA) following treatment with subcutaneous and intravenous abatacept published in The Journal of Rheumatology
    • 16 Jun 2018 Results presented at the 19th Annual Congress of the European League Against Rheumatism
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