At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis
- ✓Current active arthritis
- ✓Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD)
- ✓Must discontinue any DMARD other than methotrexate prior to first dose of study medication
- ✕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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Abatacept and Placebo for Juvenile Rheumatoid Arthritis. Completed, enrolled 214 participants across 36 sites in 11 countries.
Detailed 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.
Study Details
Timeline
Interventions
IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).
IV infusions, IV, N/A, every 4 weeks, 6 months.
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