UMIN-CTR Clinical Trial

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

Ulcerative Colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

toto.rikako@gmail.com

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

Email

toto.rikako@gmail.com

Institute

Nagasaki University Hospital

Institute

Department

Personal name

Organization

Nagasaki University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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