Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHI… (NCT00339157) | Clinical Trial Compass
CompletedPhase 2/3
Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
France24 participantsStarted 2006-05-11
Plain-language 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.
Who can participate
Age range2 Years – 20 Years
SexALL
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Inclusion Criteria:
* SO-JIA (Edmonton's revision of Durban's consensus conference criteria)
* Age: at least 2 years and less than 20 years at treatment initiation
* Disease duration of at least 6 months
* Failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg)
* Active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric Rheumatologists, with at least 3 of the following criteria when assessing Giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a Children Health Assessment Questionnaire (CHAQ, Ref \[9\]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (ESR) equal to or higher than 20.
* In the absence of disease-related fever, either CRP or first hour ESR or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated.
* Patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for t…
What they're measuring
1
30% improvement of JIA activity after 1 month compared to day 1 according to Giannini's core-set criteria, ie 30% improvement of at least 3 of the 6 items and no more than one item worsened by 30% or more.
Timeframe: Day 1, 1 Month
2
Number of active arthritis
Timeframe: Day 1, 1 Month
3
Number of joints with limitation of motion
Timeframe: Day 1, 1 Month
4
Physician assessment of disease activity
Timeframe: Day 1, 1 Month
5
Parent or patient's assessment of disease activity
Timeframe: Day 1, 1 Month
6
Childhood health assessment questionnaire
Timeframe: Day 1, 1 Month
7
First hour ESR)
Timeframe: First hour
8
Improvement of systemic symptoms between day 1 and month 1 as assessed by the resolution of the fever if present initially, by a 50% decrease or a normalization of the C-reactive protein and of the first hour ES