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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012214
Receipt No. 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

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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
Email 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
Email yoshizakiay-der@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014282

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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