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: 01 Apr 2017
At a glance
- Drugs Abatacept (Primary)
- Indications Juvenile rheumatoid arthritis
- Focus Therapeutic Use
- Sponsors Bristol-Myers Squibb
- 07 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).
- 03 Sep 2015 Planned primary completion date changed from 1 Dec 2015 to 1 Nov 2015 as per ClinicalTrials.gov record.