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

NCT ID: NCT05132231

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 394 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-22
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Brodalumab initiator

Eligible adult participants who are enrolling into the SILIQ (brodalumab) Patient Support Program (PSP) and initiating brodalumab as per routine care.

Brodalumab

Intervention Type: BIOLOGICAL

Brodalumab

Matched cohort

Participants treated with other therapies, with similar characteristics as the subgroup (participants who can be linked to an administrative health services database) of brodalumab treated participants such as age, gender/sex, comorbidities, and prior biologic experience.

Matched cohort

Intervention Type: BIOLOGICAL

Matched cohort

Interventions

Brodalumab

Brodalumab

Intervention Type: BIOLOGICAL

Matched cohort

Matched cohort

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Barbeau

Role: STUDY_DIRECTOR

Bausch Health

Locations

CARE Site 42

Calgary, Alberta, Canada

CARE Site 26

Calgary, Alberta, Canada

CARE Site 15

Calgary, Alberta, Canada

CARE Site 18

Edmonton, Alberta, Canada

CARE Site 41

Edmonton, Alberta, Canada

CARE Site 21

Edmonton, Alberta, Canada

CARE Site 37

Edmonton, Alberta, Canada

CARE Site 28

Sherwood Park, Alberta, Canada

CARE Site 31

Vancouver, British Columbia, Canada

CARE Site 36

Winnipeg, Manitoba, Canada

CARE Site 12

Winnipeg, Manitoba, Canada

CARE Site 35

Saint Johns, Newfoundland and Labrador, Canada

CARE Site 11

Ajax, Ontario, Canada

CARE Site 05

Barrie, Ontario, Canada

CARE Site 06

Greater Sudbury, Ontario, Canada

CARE Site 20

Guelph, Ontario, Canada

CARE Site 14

Hamilton, Ontario, Canada

CARE Site 24

Hamilton, Ontario, Canada

CARE Site 23

London, Ontario, Canada

CARE Site 22

London, Ontario, Canada

CARE Site 09

London, Ontario, Canada

CARE Site 33

Markham, Ontario, Canada

CARE Site 44

Mississauga, Ontario, Canada

CARE Site 51

Niagara Falls, Ontario, Canada

CARE Site 48

North York, Ontario, Canada

CARE Site 27

Oshawa, Ontario, Canada

CARE Site 13

Richmond Hill, Ontario, Canada

CARE Site 49

Toronto, Ontario, Canada

CARE Site 16

Toronto, Ontario, Canada

CARE Site 32

Whitby, Ontario, Canada

CARE Site 38

Drummondville, Quebec, Canada

CARE Site 07

Laval, Quebec, Canada

CARE Site 50

Laval, Quebec, Canada

CARE Site 04

Montreal, Quebec, Canada

CARE Site 46

Québec, Quebec, Canada

CARE Site 30

Québec, Quebec, Canada

CARE Site 17

Québec, Quebec, Canada

CARE Site 52

Saint-Charles-Borromée, Quebec, Canada

CARE Site 39

Saint-Jérôme, Quebec, Canada

CARE Site 47

Sherbrooke, Quebec, Canada

CARE Site 40

Westmount, Quebec, Canada

CARE Site 03

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

BHC-CANDerm-003

Identifier Type: -

Identifier Source: org_study_id