NCT05132231Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 394 (actual)
- First submitted
- 22 Oct 2021
- Start date
- 22 Oct 2021
- Primary completion date
- 5 Feb 2025
- Lead sponsor
- Bausch Health Americas, Inc.
- Diseases
- Psoriasis
- NCT number
- NCT05132231
What you commit to
- Study type: Observational
- Participants enrolled: 394
- From 22 Oct 2021 to the primary completion date, 5 Feb 2025
- 42 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in an interventional clinical trial concurrently or within the last 30 days prior to providing verbal consent to participate in this study.
Other illness
- Patient with Crohn's disease or with clinically significant hypersensitivity to brodalumab or to any of the excipients or component of the container (contraindications as per the Product Monograph).
- Presence of any other serious and/or uncontrolled medical condition that, in the opinion of the investigator, prohibits the patient from participating in the study.
Other
- Not willing or able to complete ePROs (electronic Patient Reported Outcomes) on an online platform (using a computer or mobile device).
- Participation in brodalumab phase IV study (NCT04149587).
Who the study is looking for
- Aged ≥ 18 years old at the time of verbal consent to participate in the study.
- Initiating brodalumab as part of routine clinical care through the SILIQ (brodalumab) Patient Support Program (PSP) for the treatment of plaque psoriasis but has not yet received their first dose. Decision to treat with brodalumab must have been reached prior to and independently of recruitment in the study.
- Must be able to read, understand, and communicate in English or French.
- Willing and able to provide informed consent on an online platform using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved electronic Informed Consent Form (ICF) in English or French.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.