Clinical trial NCT05626088: A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil
Official title: Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 1006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with UC or CD with vedolizumab prescription, residing in Brazil and agree to participate in the program.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies
timeFrame: Up to approximately 9 years
Secondary outcomes:
measure: Number of Participants With Therapies Used Before Vedolizumab Treatment
timeFrame: Up to approximately 9 years
measure: Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional and Advanced Therapies
timeFrame: Up to approximately 9 years
measure: Number of Participants With Comorbidities Associated or not With CD or UC
timeFrame: Up to approximately 9 years
measure: Duration of Disease
timeFrame: Up to approximately 9 years
measure: Percentage of Participants Diagnosed With UC or CD
timeFrame: Up to approximately 9 years
measure: Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)
timeFrame: Up to approximately 9 years
measure: Number of Participants Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort
timeFrame: At the index date (vedolizumab initiation), and at 14 and 52 weeks from index date
measure: Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD
timeFrame: Up to approximately 9 years
measure: Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF
timeFrame: Up to approximately 9 years
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Pesquisare Saúde S/S Ltda
state: São Paulo
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: