NCT04872491

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Colitis, Ulcerative
• Crohn Disease

Timeline

• Start date: 2021-10-22
• Primary completion: 2024-07-17
• Completion: 2024-07-17
• First posted: 2021-05-04
• Last updated: 2024-07-22

Locations

40 sites across 1 country: China