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A Study of Vedolizumab in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease

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ClinicalTrials.gov Identifier: NCT04799496
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:

In this study, participants with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice.

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


Condition or disease
Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease

Detailed Description:

This is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (IBD) (UC or CD), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an TNF-alpha antagonist. This study will evaluate the safety and effectiveness of 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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post-Marketing Surveillance Study (Usage Results Study) of Vedolizumab for the Approved Indications in South Korea
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Group/Cohort
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 and have initiated vedolizumab treatment in a routine clinical practical setting in South Korea, will be observed prospectively.



Primary Outcome Measures :
  1. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 18 weeks after the end of treatment (up to Week 70) ]
  2. Percentage of Participants With Adverse Drug Reactions (ADRs) [ Time Frame: Baseline up to 18 weeks after the end of treatment (up to Week 70) ]
  3. Percentage of Participants With Serious Adverse Drug Reactions (SADRs) [ Time Frame: Baseline up to 18 weeks after the end of treatment (up to Week 70) ]
  4. Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to 18 weeks after the end of treatment (up to Week 70) ]
  5. Percentage of Participants With Unexpected Adverse Events (AEs) [ Time Frame: Baseline up to 18 weeks after the end of treatment (up to Week 70) ]
  6. Percentage of Participants With Unexpected ADRs [ Time Frame: Baseline up to 18 weeks after the end of treatment (up to Week 70) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Clinical Response [ Time Frame: Up to Week 52 ]
    Clinical response:reduction of Mayo score of>=3points and>=30% 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 CDAI score>=70 points from baseline score in CD participants. Mayo score:instrument to measure disease activity of UC; 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/symptoms 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.

  2. Percentage of Participants With Clinical Remission [ Time Frame: Up to Week 52 ]
    Clinical remission is defined as: the Mayo score less than or equal to (<=2) and no individual sub-score greater than (>) 1 point in the ulcerative colitis (UC) participants; and Crohn's Disease Activity Index (CDAI) score less than (<) 150 points in the Crohn's disease (CD) participants. Mayo score: instrument to measure disease activity of UC; 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/symptoms 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.

  3. Percentage of Participants With Mucosal Healing [ Time Frame: Up to Week 52 ]
    Mucosal healing is defined as: the Mayo endoscopic sub-score of <=1 point in the UC participants; and Crohn's Disease Endoscopic Index of Severity (CDEIS) score <3.5 points in the CD participants. Mayo score: instrument to measure disease activity of UC; 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 CDEIC 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

1. 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.

Exclusion Criteria:

  1. With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
  2. With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799496


Contacts
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Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
Additional Information:
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04799496    
Other Study ID Numbers: Vedolizumab-4023
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Inflammatory Bowel Diseases
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes