UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038624 |
|---|---|
| Receipt number | 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 | 2023/11/24 15:31:05 |
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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
Endoscopic remission (mSES-CD<4) at week 26
Key secondary outcomes
Complete mucosal healing 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
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
sebio.gast@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
253
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
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
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044018
| Research Plan | |
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| Registered date | File name |
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