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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038624
Receipt No. R000044018
Scientific Title Small Bowel Endoscopic Healing by Biologics in Patients with Crohn's Disease
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/19

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Basic information
Public title Small Bowel Endoscopic Healing by Biologics in Patients with Crohn's Disease
Acronym SEBIO study
Scientific Title Small Bowel Endoscopic Healing by Biologics in Patients with Crohn's Disease
Scientific Title:Acronym SEBIO study
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Aims of this study is to evaluate the efficacy of biologics on small bowel mucosal healing in patients with on Crohn's disease.
Biologics used in this study are following;TNF alpha antagonists(Infliximab,Adalimumab);IL12/23 antagonist(Ustekinumab);Integrin alpha4beta7 antagonist(Vedolizumab)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete mucosal healing at week 26
Key secondary outcomes Endoscopic remission (mSES-CD<5) at week 26
Endoscopic response (reduction in mSES-CD by 50% or more) at week 26
Risk factor for the primary outcome measures
PK of biologics
Clinical remission and Biological remission at week 26

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who is diagnosed as ileocolonic or ileal Crohn's disease
2.Patients who are considering starting or changing treatment with biologics (infliximab, adalimumab, ustekinumab, vedolizumab)
3. Patients who have small bowel ulceration on Balloon-assisted enteroscopic examination
Key exclusion criteria 1.Patients with purely colonic Crohn's disease
2.Patients who had undergone colostomy or ileostomy.
3.Patients who could not underwent balloon enteroscopy because of strictures
4.Patients expected to undergo small bowel surgery in the near future
5.Current gastrointestinal infection
6.History of malignant disease
7.Patients suffering from tuberculosis, hepatitis B or C.
8.Pregnancy
9.Unable to sign informed consent
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Watanabe
Organization Tokyo Medical and Dental University
Division name TMDU Advanced Research Institute
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5877
Email mamoru.gast@tmd.ac.jp

Public contact
Name of contact person
1st name Kento
Middle name
Last name Takenaka
Organization Tokyo Medical and Dental University
Division name Gastroenterology and Hepatology
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5877
Homepage URL
Email sebio.gast@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University IRB
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel 03-5803-5096
Email info.bec@tmd.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
2019 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2022 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information National wide multicenter study

Management information
Registered date
2019 Year 11 Month 19 Day
Last modified on
2019 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044018

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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