Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Etaplus
Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
1 other identifier
interventional
126
1 country
1
Brief Summary
The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2017
CompletedNovember 20, 2025
September 1, 2025
3.4 years
August 13, 2013
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
one year
Secondary Outcomes (5)
Wallace criteria
one year
anti-etanercept antibodies levels
one year
analogical visual scale
one year
arthritis number
one year
number of limited joints
one year
Study Arms (1)
Single arm: etanercept
OTHERPatients treated with etanercept for JIA
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Necker
Paris, 75015, France
Related Publications (1)
Bader-Meunier B, Krzysiek R, Lemelle I, Pajot C, Carbasse A, Poignant S, Melki I, Quartier P, Choupeaux L, Henry E, Treluyer JM, Belot A, Hacein-Bey-Abina S, Urien S. Etanercept concentration and immunogenicity do not influence the response to Etanercept in patients with juvenile idiopathic arthritis. Semin Arthritis Rheum. 2019 Jun;48(6):1014-1018. doi: 10.1016/j.semarthrit.2018.09.002. Epub 2018 Sep 17.
PMID: 30396593RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigitte Bader-Meunier, MD, PhD
Necker Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2013
First Posted
January 8, 2014
Study Start
October 1, 2013
Primary Completion
February 28, 2017
Study Completion
March 30, 2017
Last Updated
November 20, 2025
Record last verified: 2025-09