Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

N/ACompletedNCT02030613

Assistance Publique - Hôpitaux de Paris126 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

126

Conditions

Juvenile Idiopathic Arthritis

Interventions

Blood testGENETIC

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Necker

Paris, France

Outcomes

Primary Outcomes

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).

Time frame: one year

Secondary Outcomes

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

Time frame: one year

anti-etanercept antibodies levels

To evaluate their influence on plasma etanercept

Time frame: 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

Time frame: one year

arthritis number

This measures one the different effects that could be related to the etenercept pharmacokinetics

Time frame: one year

number of limited joints

This measures one the different effects that could be related to the etenercept pharmacokinetics

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.