Status:
RECRUITING
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Lead Sponsor:
Takeda
Conditions:
Ulcerative Colitis
Crohn's Disease
Eligibility:
All Genders
18+ years
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 ...
Detailed Description
This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05428345
Start Date
September 25 2023
End Date
November 30 2027
Last Update
October 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10326