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

Launched by BAUSCH HEALTH AMERICAS, INC. · Nov 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called brodalumab on people with plaque psoriasis, a skin condition that can cause red, itchy patches. The aim is to understand how this treatment impacts patients' quality of life and their ability to work. The study will last for 12 months and includes about 500 participants from various locations across Canada who are starting brodalumab treatment as part of their usual care.

To be eligible for the study, participants must be at least 18 years old, be starting brodalumab through a specific support program, and be able to read and understand English or French. They should also be willing to complete some online surveys about their health experiences. It's important for potential participants to know that they cannot be part of other clinical trials at the same time or have certain medical conditions that might affect their participation. If they decide to join, they will provide their consent electronically and will be observed for a full year to collect data on their health and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥ 18 years old at the time of verbal consent to participate in the study.
• • 2. 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.
• • 3. Must be able to read, understand, and communicate in English or French.
• • 4. 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.
• Exclusion Criteria:
• • 1. Not willing or able to complete ePROs (electronic Patient Reported Outcomes) on an online platform (using a computer or mobile device).
• • 2. Participation in brodalumab phase IV study (NCT04149587).
• • 3. Participation in an interventional clinical trial concurrently or within the last 30 days prior to providing verbal consent to participate in this study.
• • 4. 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).
• • 5. 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.