- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00339157
Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
July 19, 2010 updated by: Institut National de la Santé Et de la Recherche Médicale, France
ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)
- 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)
- 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).
- Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients versus no more than 10% in the placebo group.
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
24
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France, 33000
- Bordeaux CHU
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Kremlin-Bicetre, France, 94270
- Kremlin-Bicetre hospital
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Lyon, France, 69437
- Hopital Lyon Edouard Herriot
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Nancy, France, 54511
- Nancy Hopital d'Enfants
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Paris, France, 75019
- Robert Debre Hospital
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Paris, France, 75015
- Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevres
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage.
- Informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough
- Teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence
- tuberculin test performed before Day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment
Exclusion Criteria:
- Previous treatment with IL-1Ra
- intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment
- Treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties)
- Contra-indication to the use of anakinra including ongoing active infection or allergy to E Coli's derivate or other components of the drug
- Previous history of malignancy or heart insufficiency
- Patients with asthma require to be previously assessed by a pneumonologist
- Obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration
- Any of the following: leucocyte counts < 3.6 x 10e9/L, polymorphonuclear neutrophil counts < 1.5 x 10e9/L, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Number of active arthritis
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Number of joints with limitation of motion
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Physician assessment of disease activity
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Parent or patient's assessment of disease activity
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Childhood health assessment questionnaire
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First hour ESR)
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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
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Secondary Outcome Measures
Outcome Measure |
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Number, severity and type of adverse events over 12 months
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Proportion of patients reaching 50%, 70% and 100% improvement of JIA activity according to Giannini's core-set criteria at each visit (day 15, month 1 to 6, month 9 and month 12)
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Proportion of patients in whom the daily dose of corticosteroids can be reduced to less than 0.3 mg/kg (less than 10 mg in patients over 34 kg) at month 6
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Proportion of patients with a normalization of the glycosylated ferritin / ferritin ratio (if lower than 1/4 initially) after 1, 2 and 6 months
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Variation of cytokine expression by PBMC between Day 1 and Month 1 and Month 6
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Antibody response at month 1 and month 6 to Pneumo 23® immunization: immunization on day 1 against Streptococcus pneumoniae
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Pharmacokinetic study at month 2 and month 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pierre Quartier-dit-Maire, MD, Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevre, 75015 Paris, France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
June 16, 2006
First Submitted That Met QC Criteria
June 16, 2006
First Posted (Estimate)
June 20, 2006
Study Record Updates
Last Update Posted (Estimate)
July 20, 2010
Last Update Submitted That Met QC Criteria
July 19, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C05-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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