Observing the effects of vedolizumab in adults with ulcerative colitis or Crohn's disease in South Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.