A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics

Trial Profile

A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

  • Drugs Abatacept (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 03 Oct 2017 Planned End Date changed from 1 Dec 2018 to 31 Dec 2018.
    • 10 Jun 2017 Biomarkers information updated
    • 01 Apr 2017 According to a Bristol Myers Squibb media release, based on the data from this and another study (CTP 700006603) 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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