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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-jRCTs031180370 |
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Date of registration:
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18/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis
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Scientific title:
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Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis |
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Date of first enrolment:
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12/11/2013 |
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Target sample size:
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5 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs031180370 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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Ayumi
Yoshizaki |
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Address:
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7-3-1 Hongo Bunkyo-ku Tokyo, Japan
113-8655
Tokyo
Japan |
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Telephone:
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+81-3-5800-8661 |
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Email:
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yoshizakiay-der@h.u-tokyo.ac.jp |
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Affiliation:
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The University of Tokyo Hospital |
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Name:
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Ayumi
Yoshizaki |
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Address:
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7-3-1 Hongo Bunkyo-ku Tokyo, Japan
113-8655
Tokyo
Japan |
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Telephone:
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+81-3-5800-8661 |
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Email:
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yoshizakiay-der@h.u-tokyo.ac.jp |
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Affiliation:
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The University of Tokyo Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)Patients with systemic sclerosis with sever skin sclerosis
2)Over 6 modified Rodnan total skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 20% during the screening period (two months)
3)no malignancy
4)from 20 years old to 80 years old
5)Agreement to contraception during the study period
6)Patients who are able to give consent in writing after reading the explanatory text
Exclusion criteria: 1)during treatment with equal drug
2)previous history of anaphylactic reactions to this drug
3)significant infection
4)significant liver damage
5)significant renal damage
6)pregnancy
7)breast-feeding
8)participating in other clinical trial within three months before the beginning of this trial
9)judged inappropriate for this study by the physicians
Age minimum:
>= 20age old
Age maximum:
< 80age old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic sclerosis
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Intervention(s)
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Administrate 8 mg/kg of tocilizumab once every four weeks for six months
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Primary Outcome(s)
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modified Rodnan total skin score
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Secondary Outcome(s)
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Thickness of skin pathological tissue, Adverse events
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Secondary ID(s)
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UMIN000012214
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date:
Contact:
ethics@m.u-tokyo.ac.jp
The University of Tokyo, Clinical Research Review Board
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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31/03/2021 |
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Date Completed:
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30/07/2019 |
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URL:
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