This trial is active, not recruiting.

Condition juvenile idiopathic arthritis
Treatment blood test
Sponsor Assistance Publique - Hôpitaux de Paris
Start date September 2013
End date November 2017
Trial size 126 participants
Trial identifier NCT02030613, P111102


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Patients treated with etanercept for JIA
blood test

Primary Outcomes

Etanercept concentration-time courses
time frame: one year

Secondary Outcomes

Wallace criteria
time frame: one year
anti-etanercept antibodies levels
time frame: one year
analogical visual scale
time frame: one year
arthritis number
time frame: one year
number of limited joints
time frame: one year

Eligibility Criteria

Male or female participants from 4 years up to 17 years old.

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

Additional Information

Official title Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Principal investigator Brigitte Bader-Meunier, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.