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. |
Register:
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JPRN |
Last refreshed on:
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17 October 2023 |
Main ID: |
JPRN-UMIN000020389 |
Date of registration:
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06/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
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Scientific title:
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Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD |
Date of first enrolment:
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2015/10/01 |
Target sample size:
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5 |
Recruitment status: |
Complete: follow-up complete |
URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023543 |
Study type:
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Interventional |
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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Kazuhiko Takehara |
Address:
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13-1 takaramachi, kanazawa
Japan |
Telephone:
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0762652343 |
Email:
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takehara@med.m.kanazawa-u.ac.jp |
Affiliation:
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Kanazawa University Hospital Dermatology |
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Name:
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Takashi Matsushita |
Address:
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13-1 takaramachi, kanazawa
Japan |
Telephone:
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0762652343 |
Email:
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t-matsushita@med.kanazawa-u.ac.jp |
Affiliation:
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Kanazawa University Hospital Dermatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Patients with a history of shock or hypersensitivity to this drug. 2.Patients who are complicated by infectious diseases. 3.Patients with a history of myocardial infarction or unstable angina. 4.Patients with reduced severe bone marrow function. 5.Women who may be pregnant or pregnant. 6.Lactating women
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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The patients with systemic sclerosis or sclerodermatous chronic GVHD.
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Intervention(s)
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treatment with tocilizumab duration: 20 weeks dosage: 8mg/kg times: 6 times Frequency: every 4 weeks
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Primary Outcome(s)
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Evaluate skin score at 0, 1, 4, 8, 12, 16, 20, 24 weeks after treatment.
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date: 29/06/2018
Contact:
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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29/06/2018 |
URL:
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