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

Study acronym: CARE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Mar 31, 2026 to Dec 2026 Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 3 of 25 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 25 entries
  2. Primary completion date changed from estimate of Feb 2025 to Feb 5, 2025 Completion date: Feb 2025 to Mar 31, 2026v7 Show 1 more changeShow less
    • Completion date: Feb 2025 to Mar 31, 2026
  3. Primary and study completion dates: Jun 2024 to Feb 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 500 to confirmed 394 · Study sites: 41 to 42v6 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 500 to confirmed 394
    • Study sites: 41 to 42
  4. Study sites: 34 to 41v5
  5. Study sites: 10 to 34v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 10v3
  2. Start date changed from estimate of Nov 2021 to Oct 22, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05132231
Lead Sponsor Bausch Health Americas, Inc.
Conditions Psoriasis
Enrollment 394 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov