UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053098 |
|---|---|
| Receipt number | R000060485 |
| Scientific Title | Evaluation of the association between Anti-alpha V beta 6 integrin antibody and the clinical course of ulcerative colitis after the induction therapy of Bio-JAK |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2024/03/09 17:52:22 |
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Basic information
Public title
Evaluation of the association between Anti-alpha V beta 6 integrin antibody and the clinical course of ulcerative colitis after the induction therapy of Bio-JAK
Acronym
Evaluation of the association between Anti-alpha V beta 6 integrin antibody and the clinical course of ulcerative colitis after the induction therapy of Bio-JAK
Scientific Title
Evaluation of the association between Anti-alpha V beta 6 integrin antibody and the clinical course of ulcerative colitis after the induction therapy of Bio-JAK
Scientific Title:Acronym
Evaluation of the association between Anti-alpha V beta 6 integrin antibody and the clinical course of ulcerative colitis after the induction therapy of Bio-JAK
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether anti-alpha V beta 6 integrin antibody is associated with the clinical course of UC treated with induction therapy by Bio-JAK.
Basic objectives2
Others
Basic objectives -Others
To investigate whether anti-alpha V beta 6 integrin antibody are associated with drug treatment response in ulcerative colitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate and treatment continuation rate at 6/14/48W after induction therapy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients enrolled in the "Comprehensive analysis in patients with ulcerative colitis and Crohn's disease using biologic agents" or in the "Usefulness of LRG in assessing disease activity in inflammatory bowel disease: an international multicenter clinical study".
2 Patients aged 18 years or older, regardless of gender
3 Patients with a confirmed diagnosis of UC based on the diagnostic criteria of the Research Group on Refractory Inflammatory Bowel Disease
4 Patients who used infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib, filgotinib, upadacitinib, or miliquizumab (Bio-JAK) (regardless of previous use of biological agents).
Key exclusion criteria
1 Pregnant women, lactating women, or patients who may be pregnant
2 Patients after total colorectal resection
3 Patients with deficient serum (0W) serum at the start of treatment
4 Patients deemed inappropriate for this study by the principal investigator (in charge)
5 No colonoscopy data before induction therapy within 6 months
6 MES 0 or 1
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Shibui |
Organization
Kitasato University Kitasato Research Institute Hospital
Division name
Advanced Center for Inflammatory Bowel Disease
Zip code
1088642
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-3444-6161
shibui.shunsuke@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Shibui |
Organization
Kitasato University Kitasato Research Institute Hospital
Division name
Advanced Center for Inflammatory Bowel Disease
Zip code
1088642
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
03-3444-6161
Homepage URL
shibui.shunsuke@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
Kitasato University Kitasato Institute Hospital
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
0334446161
shibui.shunsuke@kitasato-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
| 2023 | Year | 12 | Month | 14 | 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
102
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 | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
The newly started Bio/JAK start date will be the observation start date, and baseline patient information, concomitant medications, clinical symptoms (e.g., PRO2) at 6W (2 weeks allowed before and after), 14W (1 month allowed before and after), and 48W (2 months allowed before and after), blood tests (CRP, LRG, WBC, etc.), stool calprotectin, imaging tests (colonoscopy examination, bowel echocardiography, etc.) will be recorded, and abdominal symptoms and newly started Bio/JAK continuation will be followed and reviewed until the end date of observation. The observation end date will be the earliest of the observation period expiration date, relapse date, or dropout date. Dropout will be defined as transfer to a different physician, interruption of visits for more than 6 months, or death.
Management information
Registered date
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060485
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