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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm: etanercept | Other | Patients treated with etanercept for JIA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Genetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| anti-etanercept antibodies levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Bader-Meunier, MD, PhD | Necker Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Necker | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30396593 | Result | 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. |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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To evaluate their influence on plasma etanercept
| one year |
| 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 |
| arthritis number | This measures one the different effects that could be related to the etenercept pharmacokinetics | one year |
| number of limited joints | This measures one the different effects that could be related to the etenercept pharmacokinetics | one year |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |