Systemic-Onset Juvenile Idiopathic Arthritis Clinical Trial
Official title:
ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)
1. Main objective: To test the efficacy of anakinra treatment in children or young adults
with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic
Arthritis (SO-JIA)
2. Design: Double blind, randomized trial testing the efficacy of one month Anakinra
treatment versus placebo (2 groups of 12 patients each). All the patients will be
treated with anakinra during the following 11 months and the dose of corticosteroids
will be gradually tapered (= descriptive part of the trial to assess the tolerance and
efficacy over 12 months).
3. Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients
versus no more than 10% in the placebo group.
4. Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria),
age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent
disease, no previous IL-1ra treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment