BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

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.