Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis (Etaplus)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

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

  • France
      • Paris, France, 75015
        • Hospital Necker

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

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm: etanercept
Patients treated with etanercept for JIA
Genetic: Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Etanercept concentration-time courses
Time Frame: 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).
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wallace criteria
Time Frame: 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
one year
anti-etanercept antibodies levels
Time Frame: one year
To evaluate their influence on plasma etanercept
one year
analogical visual scale
Time Frame: one year
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
Time Frame: one year
This measures one the different effects that could be related to the etenercept pharmacokinetics
one year
number of limited joints
Time Frame: one year
This measures one the different effects that could be related to the etenercept pharmacokinetics
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Brigitte Bader-Meunier, MD, PhD, Necker Hospital

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.

General Publications

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 (Actual)

October 1, 2013

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimated)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P111102

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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