Conditions: Juvenile Rheumatoid Arthritis
Keywords: Juvenile Idiopathic Arthritis
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 214
Healthy volunteers: no

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 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.

Detailed description:

Arms:
arm 1: Double Blind Period arm 2: Double Blind Period arm 3: None

Interventions: intervention 1: Abatacept intervention 2: Placebo intervention 3: Abatacept
Intervention descriptions: intervention 1: IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier). intervention 2: IV infusions, IV, N/A, every 4 weeks, 6 months. intervention 3: 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

Protocol document: