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

Overview

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 Title of Study: “Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: January 2, 2025

Detailed Description

This is a non-interventional, observational study in participants with IBD participating in the PSP. This study will enroll approximately 1800 participants. Data collection will be done in 2 components, one is retrospective for participants included in the program before the study starts (from 2016 until study start date) and second is the prospective for participants that were already part of PSP. Participants will be assigned to following two observational cohorts: – UC participants – CD participants This single country trial will be conducted in Brazil. The duration of this observational study will be approximately 26 months.

Interventions

  • Other: No Intervention
    • This is a non-interventional study.

Arms, Groups and Cohorts

  • UC Participants
    • Participants diagnosed with UC with prescription of vedolizumab, were included in the PSP program before the study starts (from 2016 until study start date of this study) will be observed retrospectively and participants who were already part of PSP or will participate after the study start will be observed prospectively.
  • CD Participants
    • Participants diagnosed with CD with prescription of vedolizumab, were included in the PSP program before the study starts (from 2016 until study start date of this study) will be observed retrospectively and participants who were already part of PSP or will participate after the study start will be observed prospectively.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Anti-Tumor Necrosis Factor (TNF) Experience
    • Time Frame: Up to approximately 9 years
    • Treatment persistence will be defined as participants who did not discontinue treatment during follow-up.

Secondary Measures

  • Number of Participants With Therapies Used Before Vedolizumab Treatment
    • Time Frame: Up to approximately 9 years
  • Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional Therapy and Anti-TNF Experience
    • Time Frame: Up to approximately 9 years
  • Number of Participants With Comorbidities Associated or not With CD or UC
    • Time Frame: Up to approximately 9 years
  • Duration of Disease
    • Time Frame: Up to approximately 9 years
  • Percentage of Participants Diagnosed With UC or CD
    • Time Frame: Up to approximately 9 years
  • Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)
    • Time Frame: Up to approximately 9 years
  • Number of Participants Based on Quality-of-life (QOL) as Assessed by Inflammatory Bowel Disease Questionnaire (IBDQ)
    • Time Frame: Up to approximately 9 years
    • The IBDQ Quest contains 32 questions. Each question within each of the domains verified in the Quest is composed of seven alternative answers. Each answer option is worth its own number in points, with 1 = worse quality of life and 7 = better quality of life, with the sum of the total points obtained in each domain. The simple sum of all domains will result in the total score obtained by the participant. The minimum IBDQ score is 32 (if the participant answered all 32 questions as 1) and a maximum of 224 (if the participant answered all 7 questions). Higher score indicates better QOL.
  • Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD
    • Time Frame: Up to approximately 9 years
  • Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF
    • Time Frame: Up to approximately 9 years
  • Number of Participants Satisfied With the “Entre Nós” Program
    • Time Frame: Up to approximately 9 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda
  • Overall Contact(s)
    • Takeda Contact, +1-877-825-3327, medinfoUS@takeda.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.