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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042540
Receipt No. R000048559
Scientific Title Prospective study of predictors of mucosal healing in anti-TNF-alpha antibody treatment for inflammatory bowel disease
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/24

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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