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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil

Conditions
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Ulcerative Colitis, Crohn's Disease

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Cohort<br>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. | Other: No Intervention<br>* This is a non-interventional study.<br>|
| Prospective Cohort<br>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. | Other: No Intervention<br>* This is a non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Advance therapies include biologics and tofacitinib. | 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 Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort | 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. | At the index date (vedolizumab initiation), and at 14 and 52 weeks from index date | 
| 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 Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF |  | Up to approximately 9 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy