Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis

Detailed Description
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Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability

Official Title
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Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Genetic: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Juvenile Idiopathic Arthritis Age <18 years and> 4 years (which corresponds to the pediatric AMM) Patient on Etanercept treatment in the context of his usual care, whatever the dose (but the dose should remain stable in the weight during the study period). The patient must have received at least one injection of etanercept before participating in the study. Signature of consent by the guardians of the child Patient affiliate or entitled to a social security scheme Exclusion Criteria: Infection progressive Pregnancy and lactation. For adolescents of reproductive age and sexually active, contraception should be used during the duration of treatment with etanercept Contraindication to treatment with Etanercept Refusal of the study

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm: etanercept<br>Patients treated with etanercept for JIA | Genetic: Blood test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etanercept concentration-time courses | estimate etanercept population pharmacokinetic parameters and concentration-effect(s) relationship(s) in patients younger than 18 years treated for juvenile idiopathic arthritis (JIA). | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wallace criteria | Evaluation of a clinical remission of Juvenile Idiopathic Arthritis (JIA). This measures one the different effects that could be related to the etenercept pharmacokinetics | one year | 
| anti-etanercept antibodies levels | To evaluate their influence on plasma etanercept | one year | 
| analogical visual scale | global activity of JIA, evaluated by the investigator. This measures one the different effects that could be related to the etenercept pharmacokinetics | one year | 
| arthritis number | This measures one the different effects that could be related to the etenercept pharmacokinetics | one year | 
| number of limited joints | This measures one the different effects that could be related to the etenercept pharmacokinetics | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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juvenile idiopathic arthritis, etanercept