UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035011 |
|---|---|
| Receipt number | R000039523 |
| Scientific Title | Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2018/11/26 21:46:06 |
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Basic information
Public title
Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Acronym
Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Scientific Title
Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Scientific Title:Acronym
Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oncostatin M and phosphorylated STAT in colonic biopsy tissue before and after treatment for patients treated with tofacitinib for ulcerative colitis were measured by ELISA and it could be a biomarker for prognostic prediction Will be examined. In addition, RNA is collected from colon biopsy tissue before and after treatment, comprehensive analysis of microRNA is performed, and a biomarker for new prognostic prediction is searched.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the amount of phosphorylated STAT change in colonic mucosa before treatment and 4 weeks after treatment and the change in disease activity before treatment and 16 weeks after treatment
Key secondary outcomes
1.Correlation between oncostatin M change in colonic mucosa before treatment and 4 weeks after treatment and disease activity change before treatment and after 16 weeks of treatment
2.Correlations between changes in peripheral blood oncostatin M, IL-6, TNF-alpha, IFN-gamma before and 4 weeks before treatment and disease activity change before and after treatment 16
3.In the comprehensive analysis of colonic mucosal microRNA before treatment and after 4 weeks, it is an item to be collected exploratory and there is a possibility of setting additional items due to future research and clinical course.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Target disease: refractory ulcerative colitis of moderate or more
2. Age: patients over 20 years old and under 75 years old
3. Gender: No prejudice
4. After receiving sufficient explanation for participation in the research, after sufficient understanding, freedom of the subject himself / herself
Patient who obtained document consent by intention.
Key exclusion criteria
1. Patients with severe liver and kidney dysfunction
2. Patients with a history of drug hypersensitivity such as allergy to the ingredients of this drug
3. Pregnant women and patients who may be pregnant or breast-feeding
4. Other patients who have been judged inappropriate as research subjects by research managers (including colorectal biopsy cases)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rikako Kinoshita |
Organization
Nagasaki University Hospital
Division name
Gastroenterology
Zip code
Address
1-7-1 Sakamoto,Nagasaki-shi,Nagasaki,Japan
TEL
0958197482
toto.rikako@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rikako Kinoshita |
Organization
Nagasaki University Hospital
Division name
Gastroenterology
Zip code
Address
1-7-1 Sakamoto,Nagasaki-shi,Nagasaki,Japan
TEL
0958197482
Homepage URL
toto.rikako@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Oncostatin M and phosphorylated STAT in colonic biopsy tissue before and after treatment for patients treated with tofacitinib for ulcerative colitis were measured by ELISA and it could be a biomarker for prognostic prediction Will be examined. In addition, RNA is collected from colon biopsy tissue before and after treatment, comprehensive analysis of microRNA is performed, and a biomarker for new prognostic prediction is searched.
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039523
