Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— Etaplus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030613
• Other study ID #: P111102
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: July 3, 2017
• Start date: October 1, 2013
• Est. completion date: March 30, 2017

Study information

• Verified date: June 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 30, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Genetic:
• Blood test

Locations

Country	Name	City	State
France	Hospital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	one year
Secondary	anti-etanercept antibodies levels	To evaluate their influence on plasma etanercept	one year
Secondary	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	one year
Secondary	arthritis number	This measures one the different effects that could be related to the etenercept pharmacokinetics	one year
Secondary	number of limited joints	This measures one the different effects that could be related to the etenercept pharmacokinetics	one year