UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043185 |
|---|---|
| Receipt number | R000049281 |
| Scientific Title | The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis |
| Date of disclosure of the study information | 2021/01/30 |
| Last modified on | 2023/08/04 10:51:23 |
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Basic information
Public title
The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis
Acronym
The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis
Scientific Title
The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis
Scientific Title:Acronym
The relationship between serum concentration of an inflammatory biomarker for intestinal mucosal status, inflammatory cytokines and clinical efficacy following vedolizumab IV treatment in Japanese subjects with moderately to severely active ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis (UC)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the serum concentration of an inflammatory biomarker for intestinal mucosal status and therapeutic efficacy at 14 weeks in Japanese subjects with moderately to severely active ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the serum concentration of an inflammatory biomarker for intestinal mucosal status and therapeutic efficacy at 14 weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who were diagnosed with ulcerative colitis at least 3 months before the date of informed consent
2) Subjects who are scheduled to receive initial administration of vedolizumab
3) Subjects with a partial Mayo score >=4 and a bloody stool score >=1 within 28 days of the scheduled initial administration of vedolizumab
4) Subjects who experienced treatment failure with at least one of the pretreatment drugs listed below
Corticosteroids
- Resistance
- Dependence
- Intolerance
Immunomodulators
(azathioprine or 6-mercaptopurine)
- Refractory cases
- Intolerance
Biologics
(anti-TNF-alpha antibody or ustekinumab)
- Inadequate response
- Loss of response
- Intolerance
Tofacitinib
- Refractory cases
- Intolerance
5) Subjects who are 18-80 years old at date of informed consent
Key exclusion criteria
1) Subjects who underwent extensive resection; subjects who underwent subtotal or total colectomy
2) Subjects with ulcerative colitis classified as predominant proctitis
3) Subjects with a history of ileostomy, colostomy, or symptomatic intestinal stricture
4) Subjects who had received any of the following drugs within the following periods prior to the initial administration of vedolizumab: infliximab (8 weeks), adalimumab (2 weeks), golimumab (4 weeks), tofacitinib (1 week), and ustekinumab (8 weeks)
5) Subjects who had received vedolizumab, natalizumab, efungumab; or anti-CD20 antibody preparations, such as rituximab, ofatumumab, and obinutuzumab
6) Subjects who had an active infection within a month before the date of informed consent
7) Subjects with a history of hypersensitivity or allergy to vedolizumab or additives contained in vedolizumab preparations
8) Subjects who have malignant tumors or a history of malignant tumors
9) Subjects who were pregnant or thought they were pregnant; subjects who were trying to get pregnant; subjects who were breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka
TEL
06-6879-5111
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Makino |
Organization
Mebix, Inc.
Division name
Devision of Study promotion
Zip code
541-0046
Address
9F Aioi Nissay Dowa Insurance Midosuji Building, 3-6-1 Hirano-cho, Chuo-ku, Osaka-shi, Osaka
TEL
06-6226-0657
Homepage URL
yuki.makino@mebix.co.jp
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita-shi, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
| 2021 | Year | 01 | Month | 30 | 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
22
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2021 | Year | 01 | Month | 30 | Day |
Last modified on
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049281
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