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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02030613 |
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Date of registration:
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13/08/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Etaplus |
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Scientific title:
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Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis |
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Date of first enrolment:
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October 1, 2013 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02030613 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Brigitte Bader-Meunier, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Necker Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
4 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Juvenile Idiopathic Arthritis
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Intervention(s)
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Genetic: Blood test
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Primary Outcome(s)
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Etanercept concentration-time courses
[Time Frame: one year]
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Secondary Outcome(s)
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anti-etanercept antibodies levels
[Time Frame: one year]
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Wallace criteria
[Time Frame: one year]
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number of limited joints
[Time Frame: one year]
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analogical visual scale
[Time Frame: one year]
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arthritis number
[Time Frame: one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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