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

Takeda

Status: Completed

Conditions: Colitis, Ulcerative

Study type: Observational

Funder types: Industry

Identifiers

NCT03535649

Vedolizumab-5045

U1111-1208-5399 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.

Exclusion criteria

1. Was treated with vedolizumab intravenous outside of the locally approved label in South Korea.
2. Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.

Trial design

105 participants in 1 patient group

Vedolizumab

Description:

Participants diagnosed with moderate to severe active UC and having failed tumor necrosis factor alpha (TNF alpha) antagonist therapy and who have initiated vedolizumab intravenous treatment between 17 August 2017 and the date when at least 100 cases are collected from approximately 15 participating sites will be observed from the date of UC diagnosis until the date when participant is enrolled into the study or until the end of treatment or death of participants or lost-to-follow up.