UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012214 |
|---|---|
| Receipt number | R000014282 |
| Scientific Title | Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2020/05/11 09:51:29 |
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Basic information
Public title
Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis
Acronym
Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis
Scientific Title
Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis
Scientific Title:Acronym
Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis
Region
| Japan |
Condition
Condition
Systemic sclerosis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of tocilizumab on skin sclerosis in patients with systemic sclerosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sum of skin scores from 17 sites of the body (modified Rodnan total skin score)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Interventions/Control_2
Continue existing conventional therapies
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key 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
Key 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 beginni
ng of this trial
9)judged inappropriate for this study by the physicians
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumi Yoshizaki |
Organization
The University of Tokyo
Division name
Department of Dermatology, Faculty of Medicine, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8661
yoshizakiay-der@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumi Yoshizaki |
Organization
The University of Tokyo
Division name
Department of Dermatology, Faculty of Medicine, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8661
Homepage URL
yoshizakiay-der@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Program for the Promotion of Fundamental Studies in Health Sciences of the National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014282
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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