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

CARE: A CAnadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Brodalumab; Biological: Matched cohort

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Veronique Gaudet; Phone Number: 514 908 4894; Email: veronique.gaudet@bauschhealth.com

Study Locations

• Canada
  • Quebec, Canada, G1W 4R4
    • Recruiting
    • CARE Site 30
  • Quebec, Canada, G3K 2P8
    • Recruiting
    • CARE Site 17
  • Quebec, Canada, G1V T3
    • Recruiting
    • CARE Site 46
  • Alberta
    • Calgary, Alberta, Canada, T2W 4X9
      • Recruiting
      • CARE Site 26
    • Calgary, Alberta, Canada, T5J 3S9
      • Recruiting
      • CARE Site 15
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • CARE Site 42
    • Edmonton, Alberta, Canada, T5J 3S9
      • Recruiting
      • CARE Site 18
    • Edmonton, Alberta, Canada, T6G 1C3
      • Recruiting
      • CARE Site 41
    • Edmonton, Alberta, Canada, T6W 0J5
      • Recruiting
      • CARE Site 21
    • Edmonton, Alberta, Canada, T6X 0N9
      • Recruiting
      • CARE Site 37
    • Sherwood Park, Alberta, Canada, T8H 0P1
      • Recruiting
      • CARE Site 28
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • CARE Site 31
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Recruiting
      • CARE Site 36
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • CARE Site 12
  • Newfoundland and Labrador
    • Saint Johns, Newfoundland and Labrador, Canada, A1E 1V4
      • Recruiting
      • CARE Site 35
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • Recruiting
      • CARE Site 11
    • Barrie, Ontario, Canada, L4M 7G1
      • Recruiting
      • CARE Site 05
    • Guelph, Ontario, Canada, N1L 0B7
      • Recruiting
      • CARE Site 20
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Recruiting
      • CARE Site 14
    • Hamilton, Ontario, Canada, L9B 1K5
      • Recruiting
      • CARE Site 24
    • London, Ontario, Canada, N6A 2C2
      • Recruiting
      • CARE Site 23
    • London, Ontario, Canada, N6A 5R9
      • Recruiting
      • CARE Site 22
    • London, Ontario, Canada, N6H 5L6
      • Recruiting
      • CARE Site 09
    • Markham, Ontario, Canada, L3P 1X3
      • Recruiting
      • CARE Site 33
    • Mississauga, Ontario, Canada, L4W 0C2
      • Recruiting
      • CARE Site 44
    • Niagara Falls, Ontario, Canada, L2E 6A6
      • Recruiting
      • CARE Site 51
    • North York, Ontario, Canada, M3B 0A7
      • Recruiting
      • CARE Site 48
    • Oshawa, Ontario, Canada, L1H 1B9
      • Recruiting
      • CARE Site 27
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Recruiting
      • CARE Site 13
    • Sudbury, Ontario, Canada, P3C 1XB
      • Recruiting
      • CARE Site 06
    • Toronto, Ontario, Canada, M5A 3R6
      • Recruiting
      • CARE Site 16
    • Toronto, Ontario, Canada, M2N 3A6
      • Recruiting
      • CARE Site 49
    • Whitby, Ontario, Canada, L1N 8M7
      • Recruiting
      • CARE Site 32
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Recruiting
      • CARE Site 38
    • Laval, Quebec, Canada, H7N 6L2
      • Recruiting
      • CARE Site 07
    • Laval, Quebec, Canada, H7P K7
      • Recruiting
      • CARE Site 50
    • Montréal, Quebec, Canada, H2E 1V4
      • Recruiting
      • CARE Site 04
    • Saint-Jérôme, Quebec, Canada, J7Z 7E2
      • Recruiting
      • CARE Site 39
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Recruiting
      • CARE Site 47
    • Westmount, Quebec, Canada, H3Z 2S6
      • Recruiting
      • CARE Site 40
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7T 0G3
      • Recruiting
      • CARE Site 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Matched cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Key demographics and clinical characteristics include: prior biologic experience, age, gender, province, disease duration, number of comorbidities.	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.	The Psoriasis Area Severity Index (PASI) score (0 to 72) is a calculation of plaque qualities, including induration/infiltration (plaque thickness), erythema, and desquamation (scaling), and the area involved with PsO (48). The investigator or qualified designee will score plaque erythema, scaling and induration (on a scale of 0 to 4) and area of involvement (on a scale of 0 to 6) for 4 body areas: head and neck, upper extremities, trunk, and lower extremities.	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.	The Static Physicians Global Assessment (sPGA) scale (0 [clear] to 4 [severe]) is designed to evaluate the assessor's global assessment of the patient's psoriasis.	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.	The Static Physicians Global Assessment (sPGA) scale (0 [clear] to 4 [severe]) is designed to evaluate the assessor's global assessment of the patient's psoriasis.	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.	Psoriasis Symptom Inventory (PSI): The severity of itch, redness, scaling, burning, stinging, cracking, flaking, and pain over the last 24 hours is assessed on a scale of 0 to 4 (0 - not at all, 1- mild, 2 - moderate, 3- severe, 4- very severe) for a total score of 32, with higher scores indicating more severe disease	baseline, 3 months, 6 months, 12 months
The number and percentage of Adverse Events (AEs) or (Serious Adverse Events) SAEs reported over 12 months post-brodalumab initiation.		12 months
Reasons for discontinuation of brodalumab therapy.	Discontinuation reason is captured on the case report form.	12 months
The number and percentage of patients who initiated brodalumab and remained on treatment after 3 months, 6 months and 12 months post-brodalumab initiation.		12 months
The mean and median time to brodalumab discontinuation.		12 months
The number of patients encountering psoriasis-related physician	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering psoriasis-related physician	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
The number of patients encountering hospital visit	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering hospital visit	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
The number of patients encountering emergency room (ER) visits	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering emergency room (ER) visits	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
The number of patients encountering psoriasis-related procedures	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering psoriasis-related procedures	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures.	baseline, 3 months, 6 months, 12 months
The number of psoriasis-related physician encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The associated costs of psoriasis-related physician encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The number of hospital encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The associated costs of hospital encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The number of emergency room (ER) visit encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The associated costs of emergency room (ER) visit encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The number of psoriasis-related procedures encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months
The associated costs of psoriasis-related procedures encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.	Healthcare encounters include: psoriasis-related physician, hospital and emergency room (ER) visits, as well as psoriasis-related procedures	12 months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Martin Barbeau, Bausch Health

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: BHC-CANDerm-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No