NCT00095173

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Conditions

• Juvenile Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept	IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).
DRUG	Placebo	IV infusions, IV, N/A, every 4 weeks, 6 months.
DRUG	Abatacept	Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing \< 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing \> 100 kg, monthly

Timeline

• Start date: 2003-12-01
• Primary completion: 2006-06-01
• Completion: 2011-11-01
• First posted: 2004-11-02
• Last updated: 2017-01-18
• Results posted: 2017-01-18

Locations

36 sites across 11 countries: United States, Austria, Brazil, France, Germany, Italy, Mexico, Peru, Portugal, Spain, Switzerland