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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kynteles Injection (Vedolizumab)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serious Adverse Events (SAEs) |  | Baseline up to 56 weeks | 
| Percentage of Participants With Adverse Drug Reactions (ADRs) |  | Baseline up to 56 weeks | 
| Percentage of Participants With Serious Adverse Drug Reactions (SADRs) |  | Baseline up to 56 weeks | 
| Percentage of Participants With Adverse Events of Special Interest (AESIs) |  | Baseline up to 56 weeks | 
| Percentage of Participants With Unexpected Adverse Events (AEs) |  | Baseline up to 56 weeks | 
| Percentage of Participants With Unexpected ADRs |  | Baseline up to 56 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to 56 weeks | 
| 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. | Baseline up to 56 weeks | 
| 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. | Baseline up to 56 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy