Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Not Applicable

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Genetic: Blood test

• Registration Number: NCT02030613
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-08-13
• Study Start: 2013-10-01
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2017-02-28
• Study Completion: 2017-03-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm: etanercept	Blood test	Patients treated with etanercept for JIA

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Necker; 🇫🇷 Paris, France