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BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

NCT00095173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2017-01-18

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-06-30
Completion
2011-11-30

Countries

  • United States
  • Austria
  • Brazil
  • France
  • Germany
  • Italy
  • Mexico
  • Peru
  • Portugal
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00095173 on ClinicalTrials.gov