A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

Last updated: March 24, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Crohn's Disease

Inflammatory Bowel Disease

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT04799496
Vedolizumab-4023
  • Ages > 18
  • All Genders

Study Summary

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice.

The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. With moderately to severely active UC and CD, who have had an inadequate responsewith, lost response to, or were intolerant to either conventional therapy or a TNF-αantagonist

  2. With moderately to severely active chronic pouchitis, who have undergoneproctocolectomy and IPAA for UC, and have had an inadequate response with, or lostresponse to antibiotic therapy.

Exclusion

Exclusion Criteria:

  1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing andincreased heart rate to the Kynteles Injection (Vedolizumab) or to any of itsexcipients

  2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis,listeriosis and opportunistic infections such as progressive multifocalleukoencephalopathy (PML)

  3. Treated with Kynteles Injection (Vedolizumab) outside of the locally approved labelin South Korea.

Study Design

Total Participants: 600
Study Start date:
June 10, 2020
Estimated Completion Date:
January 14, 2026

Study Description

This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (ulcerative colitis (UC) or Crohn's disease (CD)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (IPAA) for UC, and have had an inadequate response with, or lost response to antibiotic therapy. This study will evaluate the safety and effectiveness of Kynteles injection (Vedolizumab) in a routine clinical practice setting under real world conditions.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-CRFs).

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Connect with a study center

  • Soon Chunhyang University Hospital Bucheon

    Bucheon, 14584
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • Good Gang-An Hospital

    Busan, 48265
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, 49267
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju, 28644
    Korea, Republic of

    Site Not Available

  • Hallym Univ. Medical Center

    Chuncheon, 24253
    Korea, Republic of

    Site Not Available

  • Kangwon National University Hospital

    Chuncheon, 24289
    Korea, Republic of

    Site Not Available

  • Daegu Patima Hospital

    Daegu, 41199
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu, 42601
    Korea, Republic of

    Site Not Available

  • Koo Hospital

    Daegu, 42644
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

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

    Daejeon, 34943
    Korea, Republic of

    Site Not Available

  • Chosun University Hospital

    Gwangju, 61453
    Korea, Republic of

    Site Not Available

  • Hanyang University Medical Center

    Gyeonggi-do, 11923
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Gyeonggi-do, 10380
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Bucheon ST. Marys Hospital

    Gyeonggi-do, 14647
    Korea, Republic of

    Site Not Available

  • DongGuk University International Hospital

    Ilsan, 10326
    Korea, Republic of

    Site Not Available

  • Ilsan Paik Hospital

    Ilsan, 10380
    Korea, Republic of

    Site Not Available

  • Jeonbuk National University Hospital

    Jeonju, 54907
    Korea, Republic of

    Site Not Available

  • CHA University Bundang Medical Center

    Seongnam, 13496
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul, 06273
    Korea, Republic of

    Site Not Available

  • Inje University Sanggye Paik Hospital

    Seoul, 01757
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • KyungHee University Hospital

    Seoul, 02447
    Korea, Republic of

    Site Not Available

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278
    Korea, Republic of

    Site Not Available

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Seoul St.Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Ulsan university Hospital

    Ulsan, 44033
    Korea, Republic of

    Site Not Available

  • Wonju Severance Christian Hospital

    Wonju, 26426
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan, 50612
    Korea, Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.