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

Last updated: May 22, 2026
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Crohn's Disease

Ulcerative Colitis

Colic

Treatment

No Intervention

Clinical Study ID

NCT05626088
Vedolizumab-4045
MACS-2022-042701
  • Ages > 18
  • All Genders

Study 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]).

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 1006
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
April 10, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Praxis Pesquisa Medica

    Sao Paulo, SP CEP 09090-790
    Brazil

    Site Not Available

  • Pesquisare Saúde S/S Ltda

    Santo André, São Paulo 09080-001
    Brazil

    Site Not Available

  • Pesquisare Saúde S/S Ltda

    Santo André 3449701, São Paulo 3448433 09080-001
    Brazil

    Site Not Available

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