Clinical trial NCT05132231: Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
Official title: CARE: A CAnadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: The percentage change from baseline of the Dermatology Life Quality Index (DLQI) at 3 months, 6 months, and 12 months post-brodalumab initiation.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: 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.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The percentage change from baseline of the Health Utility Index (HUI2) at 3 months, 6 months, and 12 months post-brodalumab initiation.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The mean Treatment Satisfaction Questionnaire for Medication (TSQM) domain scores at baseline, 3 months, 6 months, and 12 months post-brodalumab initiation.
timeFrame: baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: 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.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: 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.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: 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.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: 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.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The percentage change from baseline of the Psoriasis Symptom Inventory (PSI) at 3, 6, and 12 months post-brodalumab initiation.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The number and percentage of Adverse Events (AEs) or (Serious Adverse Events) SAEs reported over 12 months post-brodalumab initiation.
timeFrame: 12 months
measure: Reasons for discontinuation of brodalumab therapy.
timeFrame: 12 months
measure: The number and percentage of patients who initiated brodalumab and remained on treatment after 3 months, 6 months and 12 months post-brodalumab initiation.
timeFrame: 12 months
measure: The mean and median time to brodalumab discontinuation.
timeFrame: 12 months
measure: The number of patients encountering psoriasis-related physician
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Associated costs of patients encountering psoriasis-related physician
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The number of patients encountering hospital visit
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Associated costs of patients encountering hospital visit
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The number of patients encountering emergency room (ER) visits
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Associated costs of patients encountering emergency room (ER) visits
timeFrame: baseline, 3 months, 6 months, 12 months
measure: The number of patients encountering psoriasis-related procedures
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Associated costs of patients encountering psoriasis-related procedures
timeFrame: baseline, 3 months, 6 months, 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: The number of hospital encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
timeFrame: 12 months
measure: The associated costs of hospital encounters in a subgroup of patients treated with brodalumab and a matched cohort at 12 months post brodalumab initiation.
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: CARE Site 42
state: Alberta
city: Calgary
country: Canada
facility: CARE Site 26
state: Alberta
city: Calgary
country: Canada
facility: CARE Site 15
state: Alberta
city: Edmonton
country: Canada
facility: CARE Site 18
state: Alberta
city: Edmonton
country: Canada
facility: CARE Site 41
state: Alberta
city: Edmonton
country: Canada
facility: CARE Site 21
state: Alberta
city: Edmonton
country: Canada
facility: CARE Site 37
state: Alberta
city: Sherwood Park
country: Canada
facility: CARE Site 28
state: Alberta
city: Vancouver
country: Canada
facility: CARE Site 31
state: British Columbia
city: Winnipeg
country: Canada
facility: CARE Site 36
state: Manitoba
city: Winnipeg
country: Canada
facility: CARE Site 12
state: Manitoba
city: Saint Johns
country: Canada
facility: CARE Site 35
state: Newfoundland and Labrador
city: Ajax
country: Canada
facility: CARE Site 11
state: Ontario
city: Barrie
country: Canada
facility: CARE Site 05
state: Ontario
city: Guelph
country: Canada
facility: CARE Site 20
state: Ontario
city: Hamilton
country: Canada
facility: CARE Site 14
state: Ontario
city: Hamilton
country: Canada
facility: CARE Site 24
state: Ontario
city: London
country: Canada
facility: CARE Site 23
state: Ontario
city: London
country: Canada
facility: CARE Site 22
state: Ontario
city: London
country: Canada
facility: CARE Site 09
state: Ontario
city: Markham
country: Canada
facility: CARE Site 33
state: Ontario
city: Mississauga
country: Canada
facility: CARE Site 44
state: Ontario
city: Niagara Falls
country: Canada
facility: CARE Site 51
state: Ontario
city: North York
country: Canada
facility: CARE Site 48
state: Ontario
city: Oshawa
country: Canada
facility: CARE Site 27
state: Ontario
city: Richmond Hill
country: Canada
facility: CARE Site 13
state: Ontario
city: Sudbury
country: Canada
facility: CARE Site 06
state: Ontario
city: Toronto
country: Canada
facility: CARE Site 49
state: Ontario
city: Toronto
country: Canada
facility: CARE Site 16
state: Ontario
city: Whitby
country: Canada
facility: CARE Site 32
state: Ontario
city: Drummondville
country: Canada
facility: CARE Site 38
state: Quebec
city: Laval
country: Canada
facility: CARE Site 07
state: Quebec
city: Laval
country: Canada
facility: CARE Site 50
state: Quebec
city: Montréal
country: Canada
facility: CARE Site 04
state: Quebec
city: Saint-Charles-Borromée
country: Canada
facility: CARE Site 52
state: Quebec
city: Saint-Jérôme
country: Canada
facility: CARE Site 39
state: Quebec
city: Sherbrooke
country: Canada
facility: CARE Site 47
state: Quebec
city: Westmount
country: Canada
facility: CARE Site 40
state: Quebec
city: Saskatoon
country: Canada
facility: CARE Site 03
state: Saskatchewan
city: Quebec
country: Canada
facility: CARE Site 46
city: Quebec
country: Canada
facility: CARE Site 30
city: Quebec
country: Canada
facility: CARE Site 17
Study officials:
affiliation: Bausch Health
name: Martin Barbeau
role: STUDY_DIRECTOR
References: