NCT05132231

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

CARE: A CAnadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Brodalumab	Brodalumab
BIOLOGICAL	Matched cohort	Matched cohort

Timeline

• Start date: 2021-10-22
• Primary completion: 2025-02-05
• Completion: 2026-03-31
• First posted: 2021-11-24
• Last updated: 2025-09-26

Locations

42 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study