BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Juvenile Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00095173

Run by

Bristol-Myers Squibb

People needed

214

Starts

2003-12-01

Expected to finish

2011-11-01

Last updated by the study team

2017-01-18

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Omaha, Nebraska, United States
• Study site — Livingston, New Jersey, United States
• Study site — New Hyde Park, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Milwaukee, Wisconsin, United States
• Local Institution — Bregenz, Austria
• Local Institution — Botucatu, Brazil
• Local Institution — Rio de Janeiro, Brazil
• Local Institution — São Paulo, Brazil
• Local Institution — Paris, France
• Local Institution — Strasbourg, France
• Local Institution — Berlin, Germany
• Local Institution — Bremen, Germany
• Local Institution — Halle, Germany
• Local Institution — Hamburg, Germany
• Local Institution — Florence, Italy
• Local Institution — Genova, Italy
• Local Institution — Milan, Italy
• Local Institution — Naples, Italy
• Local Institution — Roma, Italy

Full record on ClinicalTrials.gov

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