Observational Study of Vedolizumab Subcutaneous Injection in Adults with Moderate to Severe Ulcerative Colitis or Crohns Disease in South Korea

What this Trial Is About

Researchers are observing adult participants in South Korea who have moderately to severely active ulcerative colitis UC or Crohns disease CD. These participants have not responded well, lost response, or experienced intolerable side effects from conventional therapy or TNF-alpha antagonists. The study aims to evaluate the safety and effectiveness of vedolizumab given as a subcutaneous injection in routine clinical practice under real-world conditions. The study will include about 600 participants who have started treatment with vedolizumab subcutaneously after showing therapeutic benefit from at least two intravenous infusions. All participants will be observed in a single group for a period of 52 weeks. This post-marketing surveillance study will collect data prospectively from medical records and record it electronically at multiple centers across South Korea over approximately six years. During the study, researchers will review safety outcomes such as serious adverse events, adverse drug reactions, and unexpected side effects up to week 52. They will also assess effectiveness by measuring clinical response, remission, and mucosal healing in participants with UC and CD. There is no new treatment given as part of this study it only collects information from current medical care. Participants health information will be monitored throughout the study period to better understand vedolizumabs use in real-world settings.

A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea