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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000024178 |
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Date of registration:
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28/09/2016 |
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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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Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis
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Scientific title:
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Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis - Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis |
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Date of first enrolment:
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2016/09/28 |
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Target sample size:
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5 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027836 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Asami Oohara |
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Address:
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Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa 236-0004, Japan
Japan |
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Telephone:
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045-787-2800 |
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Email:
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asami_sherry@yahoo.co.jp |
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Affiliation:
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Yokohama City University Hospital Pediatrics |
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Name:
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Asami Oohara |
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Address:
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Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa 236-0004, Japan
Japan |
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Telephone:
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045-787-2800 |
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Email:
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asami_sherry@yahoo.co.jp |
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Affiliation:
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Yokohama City University Hospital Pediatrics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1 Pulmonary tuberculosis, active bacterial infection or deep mycotic infection 2 Infection of HIV, HCV, HBV 3 Administration of live vaccine within 4 weeks 4 Cardiac dysfunction 5 Pregnant subjects or subjects who do not agree with contraception during the study period
Age minimum:
2years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Systemic-onset juvenile idiopathic arthritis(sJIA)
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Intervention(s)
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Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeks
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Primary Outcome(s)
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ACR pedi30 at week 24
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Secondary Outcome(s)
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Safety dose of corticosteroids biomarkers of disease activity(MMP-3, IL-6, and IL18) ultrasonography
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Source(s) of Monetary Support
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self funding
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Ethics review
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Status: YES
Approval date:
Contact:
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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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