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A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants

Colitis, Ulcerative Clinical Trial

Official title:
Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis Korean Patients: a Multicenter Post-marketing Observational Study

Clinical Trial Summary

The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.

Clinical Trial Description

This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous.

The study will enroll approximately 100 participants. All participants will be enrolled in one observational group: Vedolizumab

Both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits.

The multi-center trial will be conducted in Republic of Korea. The overall duration of study will be approximately 15 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03535649
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date August 17, 2017
Completion date December 18, 2018
View Details
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