Status:
COMPLETED
BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Juvenile Rheumatoid Arthritis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis;
- Current active arthritis;
- Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD);
- Subjects must discontinue use of any DMARD other than methotrexate prior to the first dose of study medication
Exclusion
- Presence of infection or history of frequent acute or chronic infections;
- Joint replacement surgery required during the study or history of surgery on more than 5 joints;
- Live vaccines within 3 months of the first dose of study medication;
- Unresolved serious bacterial infection or chronic bacterial infection;
- Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash, hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00095173
Start Date
December 1 2003
End Date
November 1 2011
Last Update
January 18 2017
Active Locations (36)
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1
Omaha, Nebraska, United States
2
Livingston, New Jersey, United States
3
New Hyde Park, New York, United States
4
Valhalla, New York, United States