A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study
2 other identifiers
observational
105
1 country
15
Brief Summary
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
15 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
August 17, 2017
CompletedFirst Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2018
CompletedResults Posted
Study results publicly available
December 23, 2019
CompletedDecember 23, 2019
December 1, 2019
1.3 years
May 14, 2018
December 2, 2019
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Week 6
Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Percentage of Participants With Pregnancy During the Study
From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Secondary Outcomes (3)
Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score
Week 14
Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
Weeks 6 and 14
Percentage of Participants With Mucosal Healing at Weeks 6 and 14
Weeks 6 and 14
Study Arms (1)
Vedolizumab
Participants diagnosed with moderate to severe active UC and having failed tumor necrosis factor alpha (TNF alpha) antagonist therapy and who have initiated vedolizumab intravenous treatment between 17 August 2017 and the date when at least 100 cases are collected from approximately 15 participating sites will be observed from the date of UC diagnosis until the date when participant is enrolled into the study or until the end of treatment or death of participants or lost-to-follow up.
Eligibility Criteria
Participants diagnosed with moderate to severe UC, having failed TNF-alpha antagonist therapy and who have initiated treatment with vedolizumab intravenous between 17 August 2017 and up until 100 participants are enrolled.
You may qualify if:
- \. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
You may not qualify if:
- Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
- Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (15)
Dankook University Hospital
Cheonan-si, Chungcheongnam-do, 31116, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Inje University Haeundae Paik Hospita
Busan, 48108, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Youngnam University Hospital
Daegu, 42415, South Korea
Goo Hospital
Daegu, 42644, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, 34943, South Korea
Kyung Hee University Hospital
Seoul, 2447, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Kangbuk Samsung Hospital
Seoul, 3181, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 6273, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
May 24, 2018
Study Start
August 17, 2017
Primary Completion
December 18, 2018
Study Completion
December 18, 2018
Last Updated
December 23, 2019
Results First Posted
December 23, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.