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Inflammatory Bowel DiseasesNCT04799496

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

An observational study of Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Takeda at 43 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Type of treatment
Injection or infusion
How many people
688 participants
Where
43 sitesSouth Korea
Study dates
10 Jun 2020to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will enroll moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist or pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Who may be able to join

  • With moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
  • With moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy.

Who cannot join

  • With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the Kynteles Injection (Vedolizumab) or to any of its excipients
  • With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML)
  • Treated with Kynteles Injection (Vedolizumab) outside of the locally approved label in South Korea.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

South Korea43 sites

  • Soon Chunhyang University Hospital Bucheon

    Bucheon-si, 14584

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Good Gang-An Hospital

    Busan, 48265

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Kosin University Gospel Hospital

    Busan, 49267

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Hallym Univ. Medical Center

    Chuncheon, 24253

  • Kangwon National University Hospital

    Chuncheon, 24289

  • Daegu Patima Hospital

    Daegu, 41199

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Kyungpook National University Hospital

    Daegu, 41404

  • Yeungnam University Medical Center

    Daegu, 42415

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Koo Hospital

    Daegu, 42644

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

    Daejeon, 34943

  • Chosun University Hospital

    Gwangju, 61453

  • Inje University Ilsan Paik Hospital

    Gyeonggi-do, 10380

  • Hanyang University Medical Center

    Gyeonggi-do, 11923

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

    Gyeonggi-do, 14647

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • DongGuk University International Hospital

    Ilsan, 10326

  • Ilsan Paik Hospital

    Ilsan, 10380

  • Jeonbuk National University Hospital

    Jeonju, 54907

  • CHA University Bundang Medical Center

    Seongnam, 13496

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Inje University Sanggye Paik Hospital

    Seoul, 01757

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830

  • KyungHee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital

    Seoul, 03722

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St.Mary's Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Ulsan university Hospital

    Ulsan, 44033

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

About this study

Official title: Regulatory Post-Marketing Surveillance Study (Usage Results Study) of Kynteles Injection (Vedolizumab) for the Approved Indications in South Korea

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).

Read the detailed 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.

Keywords
Drug Therapy
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04799496
Study groupRoleWhat they receive
Kynteles Injection (Vedolizumab)Participants with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF-α) antagonist or participants with pouchitis, who have undergone proctocolectomy and IPAA for UC, and have had an inadequate response with, or lost response to antibiotic therapy and have initiated Kynteles injection (Vedolizumab) treatment in a routine clinical practical setting in South Korea, will be observed prospectively.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Serious Adverse Events (SAEs)

    Measured: Baseline up to 56 weeks

  2. Percentage of Participants With Adverse Drug Reactions (ADRs)

    Measured: Baseline up to 56 weeks

  3. Percentage of Participants With Serious Adverse Drug Reactions (SADRs)

    Measured: Baseline up to 56 weeks

  4. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Measured: Baseline up to 56 weeks

  5. Percentage of Participants With Unexpected Adverse Events (AEs)

    Measured: Baseline up to 56 weeks

  6. Percentage of Participants With Unexpected ADRs

    Measured: Baseline up to 56 weeks

Secondary outcomes (3)

  1. Percentage of Participants With Clinical Response

    Clinical response: reduction of Mayo score of >=3 points and >=30 percent (%) from baseline score, with an accompanying decrease in rectal bleeding sub-score >=1 point/an absolute rectal bleeding sub-score of <=1 point in UC participants; and reduction of Crohn's Disease Activity Index (CDAI) score >=70 points from baseline score in CD participants. Mayo score consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, and endoscopic findings. Each graded from 0-3. Total score range of 0-12. Higher scores indicating more severity. CDAI assesses CD based on clinical signs such as number of liquid stools, intensity of abdominal pain, general wellbeing (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items. Total score ranged from 0-600 points. Higher score indicating more severity.

    Measured: Baseline up to 56 weeks

  2. Percentage of Participants With Clinical Remission

    Clinical remission: Mayo score <=2; no individual sub-score greater than (>) 1 point in UC; CDAI score <150 points in CD; and Modified Pouchitis Disease Activity Index (mPDAI) score <5 and reduction in overall score by greater than or equal to (>=) 2 points from baseline score in pouchitis. Mayo score consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, endoscopic findings. Each graded from 0-3. Total score range: 0-12. Higher scores-more severity. CDAI assesses CD based on clinical signs-number of liquid stools, intensity of abdominal pain, general wellbeing (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination, hematocrit (objective). CDAI score: sum of weighted scores for subjective and objective items. Total score:0-600 points. Higher score-more severity. mPDAI score ranges from 0-12 where <5=quiescent; 5-8=moderately active; 9-12=severely active disease.

    Measured: Baseline up to 56 weeks

  3. Percentage of Participants With Mucosal Healing

    Mucosal healing is defined as: the Mayo endoscopic sub-score of less than or equal to (<=) 1 point in the UC participants; and Crohn's Disease Endoscopic Index of Severity (CDEIS) score less than (<) 3.5 points in the CD participants. Mayo score consists of 4 variables: stool frequency, rectal bleeding, physician rating of disease activity, and endoscopic findings. Each graded from 0-3. Total score range of 0-12. Higher scores indicating more severity. CDEIS is an index of determining the severity of CD. The CDEIS considers rectum, sigmoid and left colon, transverse colon, right colon, ileum in terms of: deep ulcerations, superficial ulcerations, surface involved by disease and ulcerated surface measured. The presence of ulcerate and non-ulcerated stenosis will be recorded in each segment. Scale ranges from 0-44 with a higher score indicating greater severity of disease.

    Measured: Baseline up to 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start10 Jun 2020
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799496
Sponsor's protocol ID
Vedolizumab-4023
Status last verified
Dec 2025
First submitted
15 Mar 2021
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Takeda at 43 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Serious Adverse Events (SAEs) (time frame: Baseline up to 56 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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