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Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil
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 \[CD\]).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Pesquisare Saúde S/S Ltda
Santo André, São Paulo, Brazil
Start Date
April 10, 2023
Primary Completion Date
December 27, 2024
Completion Date
May 29, 2026
Last Updated
February 25, 2026
1,006
ACTUAL participants
No Intervention
OTHER
Lead Sponsor
Takeda
NCT06226883
NCT07271069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06975722