UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Acronym	Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Scientific Title	Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Scientific Title:Acronym	Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Region	Japan

Condition
Condition	Crohn's disease, Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to measure the blood trough level, cytokines, and inflammatory proteins of patients who have been introduced or maintained with anti-TNF-alpha antibody for inflammatory bowel disease, and evaluate the relationship with mucosal healing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association with mucosal healing 54 weeks (newly introduced cases) or 56 weeks (maintenance administration cases) after the start of the study (identification of mucosal healing predictors)
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have been diagnosed with Crohn's disease or ulcerative colitis and are receiving or will be receiving anti-TNF-alpha antibody(infliximab or adalimumab) at Fukuoka University Hospital
Key exclusion criteria	1) Patients with serious infections 2) Patients with malignant tumors 3) Patients with severe intestinal stricture, short bowel syndrome, stoma 4) Patients who do not consent to the study 5) Patients who are judged not suitable for this trial by the doctor
Target sample size	300

Research contact person
Name of lead principal investigator	1st name So Middle name Last name Imakiire
Organization	Fukuoka University School of Medicine
Division name	Gastroenterology
Zip code	814-0180
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Email	imaso0623@gmail.com

Public contact
Name of contact person	1st name So Middle name Last name Imakiire
Organization	Fukuoka University School of Medicine
Division name	Gastroenterology
Zip code	814-0180
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	imaso0623@gmail.com

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Fukuoka University
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	Fukuoka University Hospital
Address	7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0180, Japan
Tel	092-801-1011
Email	rinshou@adm.fukuoka-u.ac.jp

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	2020 Year 12 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 11 Month 04 Day
Date of IRB	2020 Year 11 Month 04 Day
Anticipated trial start date	2020 Year 11 Month 04 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Colonoscopy will be performed to evaluate SES-CD for Crohn's disease and Mayo score and UCEIS for ulcerative colitis. In addition, IFX/ADA blood concentration, cytokines such as TNF-alpha, IFN-gamma, IL-6, IL-17, TGF-beta in blood and colon tissue, oncostatin M, LRG, fecal calprotectin will be measured to evaluate its association with mucosal healing.

Management information
Registered date	2020 Year 11 Month 24 Day
Last modified on	2020 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048559