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: 23 Feb 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

    • 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).
    • 08 Jun 2017 Results published in a Bristol-Myers Squibb media release.
    • 01 Apr 2017 According to a Bristol Myers Squibb media release, based on the data from this and another study (CTP 700231962) the company has filed a supplemental application for a partial change in approved items of manufacturing and marketing approval with the Ministry of Health, Labour and Welfare (MHLW), Japan for Orencia for intravenous infusion 250 mg, in the treatment of active polyarticular juvenile idiopathic arthritis (JIA).
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