Conditions: Juvenile Idiopathic Arthritis
Keywords: juvenile idiopathic arthritis compassionate use open label
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: no

Brief summary:
The main objective of this study is to evaluate the safety of adalimumab in patients 2 to \< 4 years of age or ≥ 4 years of age weighing \< 15 kg, with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.

Detailed description:

Arms:
arm 1: Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.

Interventions: intervention 1: Adalimumab
Intervention descriptions: intervention 1: Adalimumab solution for injection for subcutaneous use.

Protocol document: