NCT05626088

A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil

Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,006 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab treatment for IBD (including Ulcerative Colitis \[UC\] and Crohn's Disease \[CD\]).

Detailed description

This is a non-interventional, observational study in participants with IBD participating in the PSP. This study will enroll approximately 2160 participants. The study is divided into two cohorts according to data collection: * Retrospective Cohort * Prospective Cohort The retrospective cohort is for participants that were included in the PSP prior to study start. This retrospective cohort will have data of participants that are actively participating in the Program and only their retrospective data will be collected. The prospective cohort is for participants that are starting their participation in the PSP using their data from the consent date until the end of the study or until the discontinuation in the PSP or in the study. Retrospective and prospective cohorts will be collected from the PSP database, which will be the only source of participants for this study. This single country trial will be conducted in Brazil. The duration of this observational study will be approximately 26 months.

Conditions

• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-12-27
• Completion: 2026-05-29
• First posted: 2022-11-23
• Last updated: 2026-02-25

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study