Juvenile Idiopathic Arthritis
Conditions
Keywords
juvenile idiopathic arthritis, etanercept
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
Interventions
GENETICBlood test
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Etanercept concentration-time courses | one year | estimate etanercept population pharmacokinetic parameters and concentration-effect(s) relationship(s) in patients younger than 18 years treated for juvenile idiopathic arthritis (JIA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wallace criteria | one year | 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 | one year | To evaluate their influence on plasma etanercept |
| analogical visual scale | one year | global activity of JIA, evaluated by the investigator. This measures one the different effects that could be related to the etenercept pharmacokinetics |
| arthritis number | one year | This measures one the different effects that could be related to the etenercept pharmacokinetics |
| number of limited joints | one year | This measures one the different effects that could be related to the etenercept pharmacokinetics |
Countries
France
Outcome results
None listed