Clinical Trial: BMS-188667 in Children and Adolescents with Juvenile Rheumatoid Arthritis


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Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb

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.

Condition	Treatment or Intervention	Phase
Juvenile Rheumatoid Arthritis	Drug: Abatacept	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Safety/Efficacy Study

Official Title: 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)

Ages Eligible for Study: 6 Years - 17 Years, Genders Eligible for Study: Both

Inclusion Criteria:

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 Criteria:

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.

BMS CALL CENTER 1-866-892-1BMS Ext. 147

Michigan
Local Institution, Detroit, Michigan, United States; Recruiting

Nebraska
Local Institution, Omaha, Nebraska, United States; Recruiting

New York
Local Institution, Valhalla, New York, United States; Recruiting

Local Institution, New Hyde Park, New York, United States; Recruiting

Ohio
Local Institution, Cincinnati, Ohio, United States; Recruiting

Local Institution, Cleveland, Ohio, United States; Recruiting

Pennsylvania
Local Institution, Duncansville, Pennsylvania, United States; Recruiting

Local Institution, Pittsburgh, Pennsylvania, United States; Recruiting

Texas
Local Institution, Houston, Texas, United States; Recruiting

Local Institution, Dallas, Texas, United States; Recruiting

Washington
Local Institution, Seattle, Washington, United States; Recruiting

Wisconsin
Local Institution, Milwaukee, Wisconsin, United States; Recruiting

Study ID Numbers: IM101-033
Record last reviewed: September 2003
Record first received: November 1, 2004
ClinicalTrials.gov Identifier: NCT00095173
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-18