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Completed

NCT Number: NCT02030613

Effective 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

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Necker

Paris, 75015, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Test

Genetic

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. anti-etanercept antibodies levels

    Time frame: one year

    To evaluate their influence on plasma etanercept

  3. 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

  4. arthritis number

    Time frame: one year

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

  5. number of limited joints

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: Etaplus

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2014
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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