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NCT Number: NCT05626088

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

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]).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pesquisare Saúde S/S Ltda

Santo André, São Paulo, 09080-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies

    Time frame: 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 outcomes

  1. Number of Participants With Therapies Used Before Vedolizumab Treatment

    Time frame: Up to approximately 9 years

  2. Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional and Advanced Therapies

    Time frame: Up to approximately 9 years

    Advance therapies include biologics and tofacitinib.

  3. Number of Participants With Comorbidities Associated or not With CD or UC

    Time frame: Up to approximately 9 years

  4. Duration of Disease

    Time frame: Up to approximately 9 years

  5. Percentage of Participants Diagnosed With UC or CD

    Time frame: Up to approximately 9 years

  6. Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)

    Time frame: Up to approximately 9 years

  7. Number of Participants Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort

    Time frame: 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.

  8. Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD

    Time frame: Up to approximately 9 years

  9. Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF

    Time frame: Up to approximately 9 years

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 23, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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