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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Korea. 2. Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03535649

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Takeda

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Medical Director
Principal Investigator Affiliation Takeda

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Korea, Republic of

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Colitis, Ulcerative
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Dankook University Hospital, Cheonan-si, Chungcheongnam-do, Korea, Republic of

Status

Not yet recruiting

Address

Dankook University Hospital

Cheonan-si, Chungcheongnam-do, 31116

Site Contact

+1-877-825-3327

Seongnam-si, Gyeonggi-do, Korea, Republic of

Status

Not yet recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620

Site Contact

+1-877-825-3327

Suwon-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

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

Suwon-si, Gyeonggi-do, 16247

Site Contact

+1-877-825-3327

Inje University Haeundae Paik Hospita, Busan, Korea, Republic of

Status

Recruiting

Address

Inje University Haeundae Paik Hospita

Busan, , 48108

Site Contact

+1-877-825-3327

Kyungpook National University Hospital, Daegu, Korea, Republic of

Status

Not yet recruiting

Address

Kyungpook National University Hospital

Daegu, , 41944

Site Contact

+1-877-825-3327

Youngnam University Hospital, Daegu, Korea, Republic of

Status

Not yet recruiting

Address

Youngnam University Hospital

Daegu, , 42415

Site Contact

+1-877-825-3327

Goo Hospital, Daegu, Korea, Republic of

Status

Not yet recruiting

Address

Goo Hospital

Daegu, , 42644

Site Contact

+1-877-825-3327

Daejeon, Korea, Republic of

Status

Not yet recruiting

Address

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

Daejeon, , 34943

Site Contact

+1-877-825-3327

Kyung Hee University Hospital, Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Kyung Hee University Hospital

Seoul, , 2447

Site Contact

+1-877-825-3327

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 3080

Site Contact

+1-877-825-3327

Kangbuk Samsung Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Kangbuk Samsung Hospital

Seoul, , 3181

Site Contact

+1-877-825-3327

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital, Yonsei University Health System

Seoul, , 3722

Site Contact

+1-877-825-3327

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 5505

Site Contact

+1-877-825-3327

Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , 6273

Site Contact

+1-877-825-3327

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 6351

Site Contact

+1-877-825-3327

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