NCT01835470

Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept

Timeline

• Start date: 2013-08-09
• Primary completion: 2015-11-24
• Completion: 2018-07-30
• First posted: 2013-04-19
• Last updated: 2021-02-26
• Results posted: 2017-01-11

Locations

13 sites across 1 country: Japan