A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
1 other identifier
observational
600
1 country
1
Brief Summary
The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedStudy Start
First participant enrolled
September 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
October 6, 2025
September 1, 2025
4.2 years
June 16, 2022
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Serious Adverse Events (SAEs)
Up to Week 52
Percentage of Participants With Adverse Drug Reactions (ADRs)
Up to Week 52
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
Up to Week 52
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Up to Week 52
Percentage of Participants With Unexpected Adverse Events (AEs)
Up to Week 52
Percentage of Participants With Unexpected ADRs
Up to Week 52
Secondary Outcomes (3)
Percentage of Participants With UC and CD Who Achieved Clinical Response
Up to Week 52
Percentage of Participants With UC and CD Who Achieved Clinical Remission
Up to Week 52
Percentage of Participants With UC and CD Who Achieved Mucosal Healing
Up to Week 52
Study Arms (1)
Participants With UC or CD
Participants diagnosed 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 and have initiated treatment with vedolizumab in a routine clinical practical setting in South Korea, will be observed prospectively for 52 weeks.
Eligibility Criteria
This study will enroll participant 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.
You may qualify if:
- With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
- With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions
You may not qualify if:
- With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance 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)
- For whom vedolizumab SC is contraindicated as per product label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
June 23, 2022
Study Start
September 25, 2023
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
October 6, 2025
Record last verified: 2025-09
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.