NCT03710486

A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants

Vedolizumab and Anti-TNFs Outcomes in Real-World Biologic Ulcerative Colitis and Crohn's Disease Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 409 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.

Detailed description

This is a retrospective, non-interventional study of participants with CD or UC. The study will review the medical charts of participants who have initiated the first or second line treatment with vedolizumab or another biologic agent (infliximab, adalimumab, or golimumab \[UC only\]) (index event) during the eligibility period to evaluate the treatment effectiveness, treatment patterns, health care utilization and safety of vedolizumab, and to provide the real-world treatment landscape with anti-TNF alpha therapies. The study will enroll approximately 400 participants, with 200 participants in each treatment cohort. All participants will be enrolled into two observational groups: * Cohort 1: Vedolizumab * Cohort 2: Other Biologics The data for participants will be collected in two main periods: * Pre-index Event Period: From the data of diagnosis of UC/CD until one day prior to the date when vedolizumab or other biologic treatment was initiated during the eligibility period. * Post-index Event Period: From the date when vedolizumab or other biologic treatment was initiated during the eligibility period until the earliest of 6 months (post-index treatment discontinuation, death of participants, lost-to-follow up, or date of chart abstraction initiation. This multi-center trial will be conducted in Spain and Portugal. The overall time for data collection in the study will be approximately 12 months and the overall duration of the study is approximately 24 months.

Conditions

• Colitis, Ulcerative
• Crohn Disease

Timeline

• Start date: 2019-02-19
• Primary completion: 2021-08-23
• Completion: 2022-02-21
• First posted: 2018-10-18
• Last updated: 2024-05-30
• Results posted: 2024-05-30

Locations

26 sites across 2 countries: Portugal, Spain