A Study of Vedolizumab in Adults in Real-World Practice

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

Sponsors

Lead Sponsor: Takeda

Source Takeda
Brief Summary

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.

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.

Overall Status Not yet recruiting
Start Date 2021-10-31
Completion Date 2024-05-31
Primary Completion Date 2024-05-31
Study Type Observational
Primary Outcome
Measure Time Frame
Percentage of Participants With Adverse Events (AEs) Up to Week 72
Percentage of Participants With Serious Adverse Events (SAEs) Up to Week 72
Percentage of Participants With Adverse Events of Special Interests (AESIs) Up to Week 72
Percentage of Participants With Adverse Drug Reactions (ADRs) Up to Week 72
Secondary Outcome
Measure Time Frame
Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score Week 14
Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Week 14
Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score Week 54
Percentage of Participants With CD Achieving Clinical Remission Based on HBI Week 54
Percentage of Participants With UC Achieving Endoscopic Remission Week 54
Percentage of Participants With CD Achieving Endoscopic Remission Week 54
Enrollment 750
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Study Director Study Director Takeda
Overall Contact

Last Name: Takeda Contact

Phone: +1-877-825-3327

Email: [email protected]

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Participants With UC or CD

Description: 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.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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