Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
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.