Clinical Trial

Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

Study acronym: CARE
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This is a phase IV, 12-month observational, prospective, open-label, multi-center study that will be conducted across approximately 50 sites in Canada for an estimated study duration of 32 months. All eligible adult participants who are enrolling into the SILIQ Patient Support Program (PSP) and initiating brodalumab as per routine care may be offered participation in the study. If the participant agrees, their verbal consent and details will be entered into the study platform by the enrolling physician so that the participant can access the electronic informed consent form. Participants who meet the eligibility criteria and provide electronic informed consent will be enrolled in the study. The study observation period will be 12 months (±15 days). Data will be collected on approximately 500 participants across academic and community centers.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-11-11; most recent amendment 2025-09-23.
Status change: Recruiting → Active, Not Recruiting 2024-10-28
Trial Details
NCT Number NCT05132231
Lead Sponsor Bausch Health Americas, Inc.
Conditions Psoriasis
Enrollment 394 participants
Start Date 2021-10-22
Primary Completion 2025-02-05 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-26