Observing the effects of vedolizumab in adults with 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
This study is looking at how well the medication vedolizumab works for adults in South Korea with moderate to severe ulcerative colitis or Crohn's disease who haven't had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | vedolizumab |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT05428345 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor adult patients in South Korea who are being treated with subcutaneous vedolizumab for moderate to severe ulcerative colitis or Crohn's disease. Participants will have previously experienced inadequate responses or intolerable side effects from conventional therapies or TNF-α antagonists. The study will collect data from medical records over approximately six years to evaluate the safety and effectiveness of vedolizumab in a real-world clinical setting. The study will enroll around 600 participants and will focus on understanding the treatment's impact on these conditions.
Who should consider this trial
Good fit: Ideal candidates are adults in South Korea with moderate to severe ulcerative colitis or Crohn's disease who have not responded adequately to previous treatments.
Not a fit: Patients with hypersensitivity to vedolizumab or those with active severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of vedolizumab for patients with ulcerative colitis and Crohn's disease.
How similar studies have performed: Other studies have shown positive outcomes with vedolizumab, indicating that this approach has been successful in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Goyang-si, Gyeonggi-do
- Donggguk University Ilsan Hospital — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.