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

This study is currently recruiting participants.
Verified January 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02030613
First received: August 13, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Juvenile Idiopathic Arthritis
Genetic: Blood test

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Etanercept concentration-time courses [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Wallace criteria [ Time Frame: one year ] [ Designated as safety issue: No ]
    Evaluation of a clinical remission of Juvenile Idiopathic Arthritis (JIA). This measures one the different effects that could be related to the etenercept pharmacokinetics

  • anti-etanercept antibodies levels [ Time Frame: one year ] [ Designated as safety issue: No ]
    To evaluate their influence on plasma etanercept

  • analogical visual scale [ Time Frame: one year ] [ Designated as safety issue: No ]
    global activity of JIA, evaluated by the investigator. This measures one the different effects that could be related to the etenercept pharmacokinetics

  • arthritis number [ Time Frame: one year ] [ Designated as safety issue: No ]
    This measures one the different effects that could be related to the etenercept pharmacokinetics

  • number of limited joints [ Time Frame: one year ] [ Designated as safety issue: No ]
    This measures one the different effects that could be related to the etenercept pharmacokinetics


Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm: etanercept
Patients treated with etanercept for JIA
Genetic: Blood test

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

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02030613

Contacts
Contact: brigitte bader-meunier, PH 00 33 1 44 49 43 32 brigitte.bader-meunier@nck.aphp.fr
Contact: Laurence Lecomte, PhD 00 33 1 58 41 35 45 laurence.lecomte@nck.aphp.fr

Locations
France
Hospital Necker Recruiting
Paris, France, 75015
Contact: Brigitte Bader-Meunier, PH    00 33 1 44 49 43 32    brigitte.bader-meunier@nck.aphp.fr   
Contact: Laurence Lecomte, PhD    00 33 1 58 41 35 45    laurence.lecomte@cch.aphp.fr   
Principal Investigator: Brigitte Bader-Meunier, PH         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02030613     History of Changes
Other Study ID Numbers: P111102
Study First Received: August 13, 2013
Last Updated: January 7, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
juvenile idiopathic arthritis
etanercept

Additional relevant MeSH terms:
Arthritis, Juvenile Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014