Status:
COMPLETED
A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis
Lead Sponsor:
Takeda
Conditions:
Inflammatory Bowel Diseases
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
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 o...
Detailed Description
This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate resp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT04799496
Start Date
June 10 2020
End Date
June 30 2025
Last Update
December 26 2025
Active Locations (43)
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1
Soon Chunhyang University Hospital Bucheon
Bucheon-si, South Korea, 14584
2
Inje University Busan Paik Hospital
Busan, South Korea, 47392
3
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
4
Good Gang-An Hospital
Busan, South Korea, 48265