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

Takeda

Status: Active, not recruiting

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05626088

MACS-2022-042701 (Other Identifier)

Vedolizumab-4045

Details and patient eligibility

About

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]).

Full 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.

Enrollment: 1,006 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Who participated or who will participate in the "Entre Nós" program and participant who consent to participate in the study.

Exclusion Criteria

• No exclusion of participants is expected in the present study and the quality of the data relies in participant reported outcomes for the "Entre Nós" program.

Trial design

1,006 participants in 2 patient groups

Retrospective Cohort

Description:

Participants diagnosed with UC or CD with prescription of vedolizumab, and were included in the PSP program (which has started in 2016) before the study starts will be observed retrospectively in this study.

Treatment:

Other: No Intervention

Prospective Cohort

Description:

Participants diagnosed with UC or CD with prescription of vedolizumab, and have participation in PSP after the study start will be observed prospectively in this study.

Treatment:

Other: No Intervention