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

NCT05132231 | Active Not Recruiting FDA Drug

• 1 other identifier: BHC-CANDerm-003
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 42

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

Outcome Measures

Primary Outcomes (4)

• The percentage change from baseline of the Dermatology Life Quality Index (DLQI) at 3 months, 6 months, and 12 months post-brodalumab initiation.

  The Dermatology Life Quality Index (DLQI) measure is self administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item has four response categories, ranging from 0 (not at all or not relevant) to 3 (very much) assessing the impact of the disease over the last week. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater health-related quality-of-life impairment.

  baseline, 3 months, 6 months, 12 months

• The percentage change from baseline of the Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) component scores at 3 months, 6 months, and 12 months post-brodalumab initiation.

  The Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) is a validated self-reported 6-item questionnaire that allows quantitative assessment of the effects of PsO on work productivity, daily activities, and classroom impairment. Scores are calculated as percentages of hours worked and percentages of productivity at work on workdays for respondents who are employed at the time of questionnaire completion.

  baseline, 3 months, 6 months, 12 months

• The percentage change from baseline of the Health Utility Index (HUI2) at 3 months, 6 months, and 12 months post-brodalumab initiation.

  The Health Utility Index (HUI2) is a 15-item questionnaire that allows researchers to classify the health status of patients and consists of seven attributes (sensation, mobility, emotion, cognition, self-care, pain, and fertility). Health state levels for descriptive responses are converted to health utilities scores using single- and multi-attribute utility functions that consist of look-up tables and mathematical formulae. Utility values for HUI2 range from -0.03 to 1.00, where a value of 1.00 indicates perfect health and a score of 0.00 corresponds to death. Negative scores represent health states considered to be worse than death.

  baseline, 3 months, 6 months, 12 months

• The mean Treatment Satisfaction Questionnaire for Medication (TSQM) domain scores at baseline, 3 months, 6 months, and 12 months post-brodalumab initiation.

  The self-administered Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire is along 4 dimensions: medication effectiveness, side effects of use, convenience of use, and global/overall satisfaction. The scale for TSQM scores ranges from 0 (extremely dissatisfied) to 100 (extremely satisfied).

  baseline, 3 months, 6 months, 12 months

Secondary Outcomes (25)

• The number and percentage of patients on brodalumab at baseline, 3 months, 6 months, and 12 months post-initiation by key patient demographics and clinical characteristics.

  baseline, 3 months, 6 months, 12 months

• The number and percentage of patients that initiated brodalumab achieving a Psoriasis Area Severity Index (PASI) response of 75, 90 or 100 at 3 months, 6 months, and 12 months post-brodalumab initiation.

  baseline, 3 months, 6 months, 12 months

• The number and percentage of patients that initiated brodalumab achieving an Static Physicians Global Assessment (sPGA) score of 0 or 1 at 3 months, 6 months, and 12 months post-brodalumab initiation.

  baseline, 3 months, 6 months, 12 months

• The number and percentage of patients that initiated brodalumab achieving a 2 grade or more improvement compared to baseline of the Static Physicians Global Assessment (sPGA) score at 3 months, 6 months, and 12 months post-brodalumab initiation.

  baseline, 3 months, 6 months, 12 months

• The percentage change from baseline of the Psoriasis Symptom Inventory (PSI) at 3, 6, and 12 months post-brodalumab initiation.

  baseline, 3 months, 6 months, 12 months

Study Arms (2)

Brodalumab initiator

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

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.

Biological: Matched cohort

Interventions

Brodalumab BIOLOGICAL

Brodalumab

Brodalumab initiator

Matched cohort BIOLOGICAL

Matched cohort

Matched cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants initiating brodalumab as part of routine clinical care and who meet all of the inclusion and none of the exclusion criteria are eligible to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Participation in an interventional clinical trial concurrently or within the last 30 days prior to providing verbal consent to participate in this study.
• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (42)

CARE Site 42

Calgary, Alberta, T2J 7E1, Canada

Location

CARE Site 26

Calgary, Alberta, T2W 4X9, Canada

Location

CARE Site 15

Calgary, Alberta, T5J 3S9, Canada

Location

CARE Site 18

Edmonton, Alberta, T5J 3S9, Canada

Location

CARE Site 41

Edmonton, Alberta, T6G 1C3, Canada

Location

CARE Site 21

Edmonton, Alberta, T6W 0J5, Canada

Location

CARE Site 37

Edmonton, Alberta, T6X 0N9, Canada

Location

CARE Site 28

Sherwood Park, Alberta, T8H 0P1, Canada

Location

CARE Site 31

Vancouver, British Columbia, V5Z 1M9, Canada

Location

CARE Site 36

Winnipeg, Manitoba, R3C 0N2, Canada

Location

CARE Site 12

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

CARE Site 35

Saint Johns, Newfoundland and Labrador, A1E 1V4, Canada

Location

CARE Site 11

Ajax, Ontario, L1S 7K8, Canada

Location

CARE Site 05

Barrie, Ontario, L4M 7G1, Canada

Location

CARE Site 06

Greater Sudbury, Ontario, P3C 1XB, Canada

Location

CARE Site 20

Guelph, Ontario, N1L 0B7, Canada

Location

CARE Site 14

Hamilton, Ontario, L8N 1Y2, Canada

Location

CARE Site 24

Hamilton, Ontario, L9B 1K5, Canada

Location

CARE Site 23

London, Ontario, N6A 2C2, Canada

Location

CARE Site 22

London, Ontario, N6A 5R9, Canada

Location

CARE Site 09

London, Ontario, N6H 5L6, Canada

Location

CARE Site 33

Markham, Ontario, L3P 1X3, Canada

Location

CARE Site 44

Mississauga, Ontario, L4W 0C2, Canada

Location

CARE Site 51

Niagara Falls, Ontario, L2E 6A6, Canada

Location

CARE Site 48

North York, Ontario, M3B 0A7, Canada

Location

CARE Site 27

Oshawa, Ontario, L1H 1B9, Canada

Location

CARE Site 13

Richmond Hill, Ontario, L4C 9M7, Canada

Location

CARE Site 49

Toronto, Ontario, M2N 3A6, Canada

Location

CARE Site 16

Toronto, Ontario, M5A 3R6, Canada

Location

CARE Site 32

Whitby, Ontario, L1N 8M7, Canada

Location

CARE Site 38

Drummondville, Quebec, J2B 5L4, Canada

Location

CARE Site 07

Laval, Quebec, H7N 6L2, Canada

Location

CARE Site 50

Laval, Quebec, H7P K7, Canada

Location

CARE Site 04

Montreal, Quebec, H2E 1V4, Canada

Location

CARE Site 46

Québec, Quebec, G1V T3, Canada

Location

CARE Site 30

Québec, Quebec, G1W 4R4, Canada

Location

CARE Site 17

Québec, Quebec, G3K 2P8, Canada

Location

CARE Site 52

Saint-Charles-Borromée, Quebec, J6E 4P6, Canada

Location

CARE Site 39

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

CARE Site 47

Sherbrooke, Quebec, J1L 0H8, Canada

Location

CARE Site 40

Westmount, Quebec, H3Z 2S6, Canada

Location

CARE Site 03

Saskatoon, Saskatchewan, S7T 0G3, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martin Barbeau

  Bausch Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 24, 2021
• Study Start: October 22, 2021
• Primary Completion: February 5, 2025
• Study Completion: March 31, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CA (42)