UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022624 |
|---|---|
| Receipt number | R000026079 |
| Scientific Title | Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2019/06/17 19:40:43 |
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Basic information
Public title
Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
Acronym
Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
Scientific Title
Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
Scientific Title:Acronym
Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD
Region
| Japan |
Condition
Condition
The patients with systemic sclerosis or sclerodermatous chronic GVHD.
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To whether tocilizumab improves the patients with systemic sclerosis or sclerodermatous chronic GVHD in long term.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate skin score every 4 weeks after treatment(total 116 weeks).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with tocilizumab
duration: 116 weeks
dosage: 8mg/kg
times: 6 times
Frequency: every 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There is no natural remission of skin sclerosis.
Key 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
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takehara |
Organization
Kanazawa University Hospital
Division name
Dermatology
Zip code
Address
13-1 takaramachi, kanazawa
TEL
0762652343
takehara@med.m.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Matsushita |
Organization
Kanazawa University Hospital
Division name
Dermatology
Zip code
Address
13-1 takaramachi, kanazawa
TEL
0762652343
Homepage URL
t-matsushita@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 06 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026079
