NCT00339157

Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS

ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic-Onset Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Anakinra
BIOLOGICAL	Pneumo23

Timeline

• Start date: 2006-05-11
• Primary completion: 2008-06-10
• Completion: 2008-06-10
• First posted: 2006-06-20
• Last updated: 2026-02-19

Locations

6 sites across 1 country: France