NCT03378388

A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life

Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

Detailed description

This is a prospective, non-interventional and pharmaco-epidemiological study of participants with IBD. The study will provide the real-life data of treatment effectiveness and safety of vedolizumab in adult participants with UC or CD. The study will enroll approximately 300 participants. All participants will be enrolled in one observational group: Vedolizumab Data will be collected and observed for 24 months in the participants who will be freely chosen by physicians to prescribe vedolizumab at the end of consultation in the recruitment period. This multi-center trial will be conducted in France. The overall time to participate in this study is 36 months, including participant's recruitment period of 12 months and treatment period of 24 months. Participants will make a minimum of 4 follow-up visits to the clinic in treatment period at Month 6, 12, 18, and 24.

Conditions

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases

Timeline

• Start date: 2018-02-13
• Primary completion: 2019-02-15
• Completion: 2019-02-15
• First posted: 2017-12-19
• Last updated: 2020-10-14

Locations

13 sites across 1 country: France