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

Recruiting

• Conditions: Crohn's Disease; Ulcerative Colitis
• Interventions: Other: No Intervention

• Registration Number: NCT05626088
• Lead Sponsor: Takeda

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 \[CD\]).

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.

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-23
• Study Start: 2023-04-10
• Primary Completion: 2024-12-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Study Completion: 2025-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2160

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Cohort	No Intervention	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	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies	Up to approximately 9 years	Treatment persistence will be defined as participants who did not discontinue treatment during follow-up. Advance therapies include biologics and tofacitinib.

Secondary Outcome Measures

Name	Time	Method
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	Advance therapies include biologics and tofacitinib.
Number of Participants Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort	At the index date (vedolizumab initiation), and at 14 and 52 weeks from index date	The SIBDQ is a validated tool used by health care professionals for assessment of participant's inflammatory bowel disease. SIBDQ contains 10 (ten) questions, and each question is composed of the 7 (seven) levels of self-perception of feeling or mood, giving an absolute score ranging from 10 (poor health related QoL) to 70 (optimal health related QoL), higher scores mean better quality of life. Index date will be defined as the start of the vedolizumab treatment.
Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD	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
Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)	Up to approximately 9 years
Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF	Up to approximately 9 years

Trial Locations

Locations (1)

Pesquisare Saúde S/S Ltda; 🇧🇷 Santo André, São Paulo, Brazil