RecruitingRecruiting
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
NCT05428345 · Takeda
In plain English
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Official title
Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
About this study
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 intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.
This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:
• Participants with UC or CD
This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
Eligibility criteria
Inclusion Criteria:
1. 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
2. With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions
Exclusion Criteria:
1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
3. For whom vedolizumab SC is contraindicated as per product label
Study design
Enrollment target: 600 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-09-25
Estimated completion: 2027-11-30
Last updated: 2025-10-06
Primary outcomes
- • 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)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (1)
Donggguk University Ilsan HospitalRecruiting
Goyang-si, Gyeonggi-do, South Korea