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: 06 Apr 2018

At a glance

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

    • 08 Mar 2018 Planned End Date changed from 30 Sep 2018 to 31 Jul 2018.
    • 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 6603).
    • 13 Dec 2017 Planned End Date changed from 31 Dec 2018 to 30 Sep 2018.
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