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

NCT00339157 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-19

No results posted yet for this study

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

DRUG

Anakinra

BIOLOGICAL

Pneumo23

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Pierre Quartier-dit-Maire, MD · Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevre, 75015 Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-11
Primary Completion
2008-06-10
Completion
2008-06-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00339157 on ClinicalTrials.gov