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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-17

Study Completion Date

2018-12-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colitis, Ulcerative

Keywords

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Drug therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Vedolizumab

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

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South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1208-5399

Identifier Type: OTHER

Identifier Source: secondary_id

Vedolizumab-5045

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Vedolizumab

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Takeda

Responsible Party

Principal Investigators

Medical Director

Locations

Dankook University Hospital

Seoul National University Bundang Hospital

The Catholic University of Korea, St. Vincent's Hospital

Inje University Haeundae Paik Hospita

Kyungpook National University Hospital

Youngnam University Hospital

Goo Hospital

The Catholic University of Korea, Daejeon St. Mary's Hospital

Kyung Hee University Hospital

Seoul National University Hospital

Kangbuk Samsung Hospital

Severance Hospital, Yonsei University Health System

Asan Medical Center

Gangnam Severance Hospital, Yonsei University Health System

Samsung Medical Center

Countries