UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015495 |
|---|---|
| Receipt number | R000018004 |
| Scientific Title | Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) |
| Date of disclosure of the study information | 2014/10/22 |
| Last modified on | 2019/05/01 16:38:17 |
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Basic information
Public title
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Acronym
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Scientific Title
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Scientific Title:Acronym
Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)
Region
| Japan |
Condition
Condition
Systemic sclerosis
Classification by specialty
| Medicine in general | Clinical immunology |
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
Skin hardness, elasticity, and viscosity evaluate by Vesmter
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
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
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)Patients who are administered the other biologics
2)Patients who have history of anaphylactic reactions to this drug
3)Patients who have HBV or who are under the septic condition
4)significant liver damage
5)significant renal damage
6)possibility of tuberculosis
7)pregnancy
8)breast-feeding
9)participating in other clinical trial within three months before the beginni
ng of this trial
10)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 | Yoshihito Shima |
Organization
Osaka University Graduate School of Medicine
Division name
Dept. of Respiratory medicine, Allergy and Rheumatic diseases
Zip code
Address
2-2 Yamada-oka, Suita, 565-0871 Japan
TEL
06-6879-3833
ryanjin@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Shima |
Organization
Osaka University
Division name
Allergy and Rheumatic Diseases
Zip code
Address
2-2 Yamada-Oka, Suita, 565-0871 Japan
TEL
06-6879-3833
Homepage URL
ryanjin@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 22 | 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
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
