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

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Juvenile Idiopathic Arthritis focused on measuring juvenile idiopathic arthritis, etanercept

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Necker

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm: etanercept

Arm Description

Patients treated with etanercept for JIA

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
anti-etanercept antibodies levels
To evaluate their influence on plasma etanercept
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
arthritis number
This measures one the different effects that could be related to the etenercept pharmacokinetics
number of limited joints
This measures one the different effects that could be related to the etenercept pharmacokinetics

Full Information

First Posted
August 13, 2013
Last Updated
July 3, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02030613
Brief Title
Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Acronym
Etaplus
Official Title
Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
juvenile idiopathic arthritis, etanercept

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm: etanercept
Arm Type
Other
Arm Description
Patients treated with etanercept for JIA
Intervention Type
Genetic
Intervention Name(s)
Blood test
Primary Outcome Measure Information:
Title
Etanercept concentration-time courses
Description
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 Outcome Measure Information:
Title
Wallace criteria
Description
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
Title
anti-etanercept antibodies levels
Description
To evaluate their influence on plasma etanercept
Time Frame
one year
Title
analogical visual scale
Description
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
Title
arthritis number
Description
This measures one the different effects that could be related to the etenercept pharmacokinetics
Time Frame
one year
Title
number of limited joints
Description
This measures one the different effects that could be related to the etenercept pharmacokinetics
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Bader-Meunier, MD, PhD
Organizational Affiliation
Necker Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Necker
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

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Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

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