NCT05056441

A Study of Real-World Outcomes of People With Crohn's Disease (CD)

ENTYVIO® Real-World Outcomes in Bio-naïve Crohn's Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 623 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to compare long-term remission in participants receiving vedolizumab (VDZ) and those receiving ustekinumab (UST). In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

Detailed description

This is a non-interventional, retrospective study of participants with CD. The study will review the medical charts of participants who have initiated the treatment with vedolizumab and ustekinumab or another biologic agent (post- index). The study will aim to enroll approximately 700 participants, with 350 participants in each of the following cohorts: * Cohort 1: Vedolizumab * Cohort 2: Ustekinumab The data for participants will be collected in two main periods: * Pre-Index Event Period: From the date of diagnosis of CD until the date of index when vedolizumab or ustekinumab was initiated during the eligibility period. * Post-Index Event Period: From one day post-index when vedolizumab or ustekinumab was initiated during the eligibility period until chart abstraction initiation, unless the date of death or loss to follow-up is before the date of chart abstraction initiation. This multi-center study will be conducted in Belgium, Australia, and Switzerland. The overall time for data collection in the study will be approximately 12 months and the long-term duration of the study is approximately 36 months.

Conditions

• Crohn Disease

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-09-24
• Last updated: 2022-10-21

Locations

31 sites across 3 countries: Australia, Belgium, Switzerland