A Study of Vedolizumab in Adults in Real-World Practice

Overview

Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease. In this study, adults 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 if participants have side effects from vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Full Title of Study: “A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 31, 2024

Detailed Description

This is a non-interventional, prospective study of participants with UC or CD who are prescribed and will start vedolizumab in the real word setting for the first time. This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions. The study will enroll approximately 750 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic data capture (eDC). All participants will be enrolled in a single observational group: • Participants with UC or CD This multi-center trial will be conducted in China. The overall duration of the study will be approximately 72 weeks.

Arms, Groups and Cohorts

  • Participants With UC or CD
    • Participants diagnosed with UC or CD who are prescribed and will start treatment with vedolizumab 300 milligram (mg), infusion, intravenously, at Weeks 0, 2, 6, and every 8 weeks thereafter for up to 54 weeks will be observed prospectively for 72 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Adverse Events (AEs)
    • Time Frame: Up to Week 72
  • Percentage of Participants With Serious Adverse Events (SAEs)
    • Time Frame: Up to Week 72
  • Percentage of Participants With Adverse Events of Special Interests (AESIs)
    • Time Frame: Up to Week 72
  • Percentage of Participants With Adverse Drug Reactions (ADRs)
    • Time Frame: Up to Week 72

Secondary Measures

  • Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score
    • Time Frame: Week 14
    • Clinical response in UC is defined as greater than or equal to (>=) 2 points reduction in partial mayo clinic score and >=25 percent (%) decrease from baseline score accompanied with >=1 point decrease in rectal bleeding sub-score or absolute rectal bleeding sub-score less than or equal to (<=) 1 point. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.
  • Percentage of Participants With Crohn’s Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)
    • Time Frame: Week 14
    • Clinical response in CD is defined as >=3-point decrease in the HBI score. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 equal to [=] very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub scores, where score less than (<) 5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (>) 16 = severe disease activity.
  • Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score
    • Time Frame: Week 54
    • Clinical remission in UC is defined as partial mayo clinic score <=2 with no sub-score >1. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.
  • Percentage of Participants With CD Achieving Clinical Remission Based on HBI
    • Time Frame: Week 54
    • Clinical remission in CD is defined as HBI score of <=4 points. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 = very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and >16 = severe disease activity.
  • Percentage of Participants With UC Achieving Endoscopic Remission
    • Time Frame: Week 54
    • Endoscopic remission in UC is defined as mayo endoscopic sub-score <=1. Mayo endoscopic subscore (findings on endoscopy), each graded from 0 to 3 where 0 = Normal mucosa or inactive disease, 1 = Mild activity (erythema, decreased vascular pattern, mild friability), 2 = Moderate activity (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe activity (spontaneous bleeding, large ulcerations). Higher scores indicating more severe disease.
  • Percentage of Participants With CD Achieving Endoscopic Remission
    • Time Frame: Week 54
    • Endoscopic remission in CD is defined as absence of any ulcers excluding aphthous ulcers.

Participating in This Clinical Trial

Inclusion Criteria

1. Diagnosed with UC or CD 2. Firstly prescribed with vedolizumab Exclusion Criteria:

1. Currently enrolled in or plan to participate in any other clinical trials (that is, interventional study) 2. Contraindicated for vedolizumab according to product package insert

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda
  • Overall Contact(s)
    • Takeda Contact, +1-877-825-3327, medinfoUS@takeda.com

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