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

StatusCompleted
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Anakinra (Drug), Pneumo23 (Biological) to Anakinra (Drug), Placebo (Other), Pneumo23 (Biological)v5
  2. Primary completion date: Jun 10, 2008v4 Show 6 more changesShow less
    • Study completion date: Jul 2008 to Jun 10, 2008
    • Start date: Jun 2006 to May 11, 2006
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised at 1 of 6 sites
    • Publications: details revised at 1 of 1 entry
    • Study arms: 0 to 2
  3. Trial status: Active, Not Recruiting to Completedv3
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00339157
Lead Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Conditions
(from sponsor)		 Systemic-Onset Juvenile Idiopathic Arthritis
Related terms Arthritis, Juvenile, Rare Diseases
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov