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A Study of Vedolizumab in Adu...

A Study of Vedolizumab in Adults in Real-World Practice

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-22

Study Completion Date

2024-07-17

Brief Summary

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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.

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Detailed Description

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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 500 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.

Conditions

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Colitis, Ulcerative Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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