CompletedNot Applicable

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

South Korea688 participantsStarted 2020-06-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Percentage of Participants With Serious Adverse Events (SAEs)

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Adverse Drug Reactions (ADRs)

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Serious Adverse Drug Reactions (SADRs)

Timeframe: Baseline up to 56 weeks

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

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Unexpected Adverse Events (AEs)

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Unexpected ADRs

Timeframe: Baseline up to 56 weeks

Trial details

NCT IDNCT04799496

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Inflammatory Bowel Diseases trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Percentage of Participants With Serious Adverse Events (SAEs)

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Adverse Drug Reactions (ADRs)

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Serious Adverse Drug Reactions (SADRs)

Timeframe: Baseline up to 56 weeks

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

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Unexpected Adverse Events (AEs)

Timeframe: Baseline up to 56 weeks

Percentage of Participants With Unexpected ADRs

Timeframe: Baseline up to 56 weeks