A Study of Vedolizumab in Adults in Real-World Practice

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04872491

Vedolizumab-5064

Details and patient eligibility

About

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 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 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

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.