A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
Regulatory Post-Marketing Surveillance Study (Usage Results Study) of Kynteles Injection (Vedolizumab) for the Approved Indications in South Korea
1 other identifier
observational
688
1 country
43
Brief Summary
In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice. The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2020
CompletedFirst Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedDecember 26, 2025
December 1, 2025
5.1 years
March 15, 2021
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Serious Adverse Events (SAEs)
Baseline up to 56 weeks
Percentage of Participants With Adverse Drug Reactions (ADRs)
Baseline up to 56 weeks
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
Baseline up to 56 weeks
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Baseline up to 56 weeks
Percentage of Participants With Unexpected Adverse Events (AEs)
Baseline up to 56 weeks
Percentage of Participants With Unexpected ADRs
Baseline up to 56 weeks
Secondary Outcomes (3)
Percentage of Participants With Clinical Response
Baseline up to 56 weeks
Percentage of Participants With Clinical Remission
Baseline up to 56 weeks
Percentage of Participants With Mucosal Healing
Baseline up to 56 weeks
Study Arms (1)
Kynteles Injection (Vedolizumab)
Participants with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF-α) antagonist or participants with pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy and have initiated Kynteles injection (Vedolizumab) treatment in a routine clinical practical setting in South Korea, will be observed prospectively.
Eligibility Criteria
This study will enroll moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist or pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.
You may qualify if:
- With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
- With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.
You may not qualify if:
- With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
- With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
- Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (43)
Soon Chunhyang University Hospital Bucheon
Bucheon-si, 14584, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Good Gang-An Hospital
Busan, 48265, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, 31151, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Hallym Univ. Medical Center
Chuncheon, 24253, South Korea
Kangwon National University Hospital
Chuncheon, 24289, South Korea
Daegu Patima Hospital
Daegu, 41199, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Kyungpook National University Hospital
Daegu, 41404, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Koo Hospital
Daegu, 42644, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, 34943, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Inje University Ilsan Paik Hospital
Gyeonggi-do, 10380, South Korea
Hanyang University Medical Center
Gyeonggi-do, 11923, South Korea
The Catholic University of Korea, Bucheon ST. Marys Hospital
Gyeonggi-do, 14647, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
DongGuk University International Hospital
Ilsan, 10326, South Korea
Ilsan Paik Hospital
Ilsan, 10380, South Korea
Jeonbuk National University Hospital
Jeonju, 54907, South Korea
CHA University Bundang Medical Center
Seongnam, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Inje University Sanggye Paik Hospital
Seoul, 01757, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, 01830, South Korea
KyungHee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital
Seoul, 03722, South Korea
Kyunghee University Hospital at Gangdong
Seoul, 05278, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St.Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Ulsan university Hospital
Ulsan, 44033, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 16, 2021
Study Start
June 10, 2020
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.