Conditions: Juvenile Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months. arm 2: Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.

Interventions: intervention 1: Etanercept intervention 2: Placebo to Etanerceot intervention 3: Methotrexate
Intervention descriptions: intervention 1: Administered by subcutaneous injection twice a week intervention 2: Administered by subcutaneous injection twice a week intervention 3: Administered orally or subcutaneously once a week at the same dose as prior to study entry

Protocol document: