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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626088
• Other study ID #: Vedolizumab-4045
• Secondary ID: MACS-2022-042701
• Status: Recruiting
• Start date: April 10, 2023
• Est. completion date: January 2, 2025

Study information

• Verified date: October 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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]).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2160
• Est. completion date: January 2, 2025
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Brazil	Praxis Pesquisa Medica	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Therapies Used Before Vedolizumab Treatment		Up to approximately 9 years
Secondary	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
Secondary	Number of Participants With Comorbidities Associated or not With CD or UC		Up to approximately 9 years
Secondary	Duration of Disease		Up to approximately 9 years
Secondary	Percentage of Participants Diagnosed With UC or CD		Up to approximately 9 years
Secondary	Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)		Up to approximately 9 years
Secondary	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
Secondary	Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD		Up to approximately 9 years
Secondary	Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF		Up to approximately 9 years

External Links

•   To obtain more information about this study, click this link.