UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Title of the study (Brief title)	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	Rikako Kinoshita
Organization	Nagasaki University Hospital
Division name	Gastroenterology
Address	1-7-1 Sakamoto,Nagasaki-shi,Nagasaki,Japan
TEL	0958197482
Email	toto.rikako@gmail.com

Public contact
Name of contact person	Rikako Kinoshita
Organization	Nagasaki University Hospital
Division name	Gastroenterology
Address	1-7-1 Sakamoto,Nagasaki-shi,Nagasaki,Japan
TEL	0958197482
Homepage URL
Email	toto.rikako@gmail.com

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039523