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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042855
Receipt No. R000048756
Scientific Title A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis
Date of disclosure of the study information 2021/01/04
Last modified on 2020/12/25

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Basic information
Public title A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis
Acronym A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis
Scientific Title A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis
Scientific Title:Acronym A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Primary Objective:
To evaluate endoscopic changes induced by vedolizumab IV by LCI classification at Week 22 in subjects with moderately to severely active UC.
Secondary Objectives:
To evaluate relationships between LCI classification and clinical remission, mucosal healing or histological remission at Weeks 22 and 54.
To evaluate relationships between LCI index and clinical remission, mucosal healing or histological remission at Weeks 22 and 54.
Exploratory Objective:
To investigate changes in various factors potentially related to changes induced by vedolizumab from baseline at Weeks 22 and 54.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes - LCI classification at Week 22
Key secondary outcomes - LCI classification at Week 54
- LCI index at Weeks 22 and 54
- Proportion of subjects with clinical remission, mucosal healing and histologic remission at Weeks 22 and 54
- Association between LCI classification and clinical remission, mucosal healing or histologic remission at Weeks 22 and 54
- Association between changes in LCI classification from Week 0 (baseline) to Week 22 and clinical remission, mucosal healing or histologic remission at Week 22
- Association between changes in LCI classification from Week 0 (baseline) to Weeks 22 or 54, and clinical remission, mucosal healing or histologic remission at Week 54
- Association between changes in LCI classification from Week 22 to Week 54 and clinical remission, mucosal healing or histologic remission at Week 54
- Relationship between LCI index and clinical remission, mucosal healing or histologic remission at Weeks 22 and 54
- Relationship between changes in LCI index from Week 0 (baseline) to Week 22 and clinical remission, mucosal healing or histologic remission at Week 22
- Relationship between changes in LCI index from Week 0 (baseline) to Weeks 22 or 54, and clinical remission, mucosal healing or histologic remission at Week 54
- Relationship between changes in LCI index from Week 22 to Week 54 and clinical remission, mucosal healing or histologic remission at Week 54

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Main Criteria for Inclusion:
[Subjects with UC]
-Subjects with a diagnosis of UC at least 3 months prior to informed consent
-Subjects who have been scheduled to receive initial administration of vedolizumab IV
-Subjects with a partial Mayo score of 5 to 9, inclusive, at screening
-Subjects who meet the following treatment failure criteria with at least one of the following agents:
>Resistant, dependent, or intolerant to corticosteroids
>Refractory or intolerant to immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
>Inadequate response, loss of response, or intolerance to biological agents (anti-TNFa antibodies or ustekinumab) or tofacitinib
-Subjects aged 20 to 80 years, inclusive, at informed consent
[Subjects without UC]
-Subjects who have been scheduled to undergo colonoscopy for disease monitoring following resection of colonic adenomas and/or hyperplastic polyps
-Subjects aged 20 to 80 years, inclusive, at informed consent
Key exclusion criteria [All subjects]
1.Subjects with a history of extensive colonic resection, subtotal or total colectomy
2.Subjects with a history of ileostomy, colostomy, or symptomatic intestinal stricture
[Subjects with UC]
1.Subjects with UC that are classified as predominant proctitis
2.Subjects who had received any of the following drugs within the designated period prior to the initial administration of vedolizumab: infliximab (8 weeks), adalimumab (2 weeks), golimumab (4 weeks), tofacitinib (1 week), and ustekinumab (8 weeks)
3.Subjects with prior exposure to vedolizumab, natalizumab, efalizumab or anti-CD20 antibodies (e.g., rituximab, ofatumumab and obinutuzumab)
4.Subjects with any evidence of an active infection within 1 month prior to the first administration of vedolizumab
5.Subjects previously diagnosed as having PML or subjects with symptoms suggestive of PML
6.Subjects with concurrent malignancies who are deemed unsuitable for enrollment by the investigator (e.g., Eastern Cooperative Oncology Group performance status of 2 or more, or are receiving cytotoxic chemotherapy, molecularly targeted therapy, or immune checkpoint inhibitors)
7.Subjects with a history of hypersensitivity reaction to vedolizumab or its components (subjects with contraindication in the vedolizumab package insert)
8.Subjects who are pregnant, are susceptible to being pregnant, are planning to be pregnant, or are lactating
[Subjects without UC]
1.Subjects with inflammatory bowel diseases, autoimmune disorders or connective tissue diseases
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code 602-8566
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL 075-251-5508
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Kazuhiko
Middle name
Last name Uchiyama
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code 602-8566
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL 075-251-5508
Homepage URL
Email k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor - Setsunan University
- Institute of Physical and Chemical Research(RIKEN)
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine Institutional Review Board
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
Tel 075-251-5111
Email rinri@koto.kpu-m.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 ・京都府立医科大学附属病院(京都府)
・京都府立医科大学附属北部医療センター(京都府)
・藤田胃腸科病院(大阪府)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 04 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
2020 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 31 Day
Last follow-up date
2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Plan
This is an open-label study to evaluate endoscopic changes induced by vedolizumab 300 mg intravenous (IV) infusion using linked color imaging (LCI) over a 46-week treatment period in Japanese patients with moderately to severely active ulcerative colitis (UC). Thirty subjects will be enrolled and relationships between LCI classification and clinical remission by complete Mayo score, LCI classification and mucosal healing by Mayo endoscopic subscore, and LCI classification and histological remission by Nancy histological index are evaluated at Weeks 22 and 54 of treatment. LCI classification is defined by assigning one of the three following categories to the region of colonic mucosa with the strongest degree of inflammation at each endoscopy: A (no redness), B (redness with visible vessels), or C (redness without visible vessels). Similar evaluations will be conducted using LCI index, which is an assessment of the redness of the inflamed mucosa that is defined as the Commission Internationale de l'Eclairage (CIE) a* value of a 40-pixel square area within the captured endoscopic image that displays the region of colonic mucosa with the strongest degree of inflammation at each endoscopy. This study will also evaluate as exploratory outcomes various factors potentially related to changes induced by vedolizumab. To this end, 30 subjects without UC will additionally be enrolled as a reference arm. Subjects without UC will undergo assessments at Week 0 and exit the study immediately without receiving vedolizumab.
The definitions in the study are provided below;
Clinical remission:Complete Mayo score is 2 or less and all subscores are 1 or less
Mucosal healing:Mayo endoscopic subscore is 1 or less
Histologic remission:Nancy histological index is 1 or less

Management information
Registered date
2020 Year 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048756

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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