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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.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2018

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

    • 31 Aug 2018 Biomarkers information updated
    • 16 Jun 2018 Results presented at the 19th Annual Congress of the European League Against Rheumatism
    • 23 Feb 2018 According to a Bristol-Myers Squibb media release, Orencia for Intravenous Infusion 250 mg (abatacept) has been approved for an additional indication of active polyarticular juvenile idiopathic arthritis (JIA) for a partial change in approved items of the manufacturing and marketing approval in Japan. The regulatory application was based on data from this and another phase III trial (CT 231692).
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