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
2 other identifiers
observational
1,006
1 country
1
Brief 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 \[CD\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedStudy Start
First participant enrolled
April 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2026
ExpectedFebruary 25, 2026
February 1, 2026
1.7 years
November 16, 2022
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies
Treatment persistence will be defined as participants who did not discontinue treatment during follow-up. Advance therapies include biologics and tofacitinib.
Up to approximately 9 years
Secondary Outcomes (9)
Number of Participants With Therapies Used Before Vedolizumab Treatment
Up to approximately 9 years
Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional and Advanced Therapies
Up to approximately 9 years
Number of Participants With Comorbidities Associated or not With CD or UC
Up to approximately 9 years
Duration of Disease
Up to approximately 9 years
Percentage of Participants Diagnosed With UC or CD
Up to approximately 9 years
- +4 more secondary outcomes
Study Arms (2)
Retrospective Cohort
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.
Prospective Cohort
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.
Interventions
Eligibility Criteria
Participants diagnosed with UC or CD with vedolizumab prescription, residing in Brazil and agree to participate in the program.
You may qualify if:
- Who participated or who will participate in the "Entre Nós" program and participant who consent to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Pesquisare Saúde S/S Ltda
Santo André, São Paulo, 09080-001, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 23, 2022
Study Start
April 10, 2023
Primary Completion
December 27, 2024
Study Completion (Estimated)
May 29, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.