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

Psoriasis Clinical Trial

— CARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132231
• Other study ID #: BHC-CANDerm-003
• Status: Recruiting
• Start date: October 22, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Bausch Health Americas, Inc.
• Contact: Veronique Gaudet
• Phone: 514 908 4894
• Email: veronique.gaudet[@]bauschhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Brodalumab
Brodalumab
• Matched cohort
Matched cohort

Locations

Country	Name	City	State
Canada	CARE Site 11	Ajax	Ontario
Canada	CARE Site 05	Barrie	Ontario
Canada	CARE Site 15	Calgary	Alberta
Canada	CARE Site 26	Calgary	Alberta
Canada	CARE Site 42	Calgary	Alberta
Canada	CARE Site 38	Drummondville	Quebec
Canada	CARE Site 18	Edmonton	Alberta
Canada	CARE Site 21	Edmonton	Alberta
Canada	CARE Site 37	Edmonton	Alberta
Canada	CARE Site 41	Edmonton	Alberta
Canada	CARE Site 20	Guelph	Ontario
Canada	CARE Site 14	Hamilton	Ontario
Canada	CARE Site 24	Hamilton	Ontario
Canada	CARE Site 07	Laval	Quebec
Canada	CARE Site 50	Laval	Quebec
Canada	CARE Site 09	London	Ontario
Canada	CARE Site 22	London	Ontario
Canada	CARE Site 23	London	Ontario
Canada	CARE Site 33	Markham	Ontario
Canada	CARE Site 44	Mississauga	Ontario
Canada	CARE Site 04	Montréal	Quebec
Canada	CARE Site 51	Niagara Falls	Ontario
Canada	CARE Site 48	North York	Ontario
Canada	CARE Site 27	Oshawa	Ontario
Canada	CARE Site 17	Quebec
Canada	CARE Site 30	Quebec
Canada	CARE Site 46	Quebec
Canada	CARE Site 13	Richmond Hill	Ontario
Canada	CARE Site 35	Saint Johns	Newfoundland and Labrador
Canada	CARE Site 39	Saint-Jérôme	Quebec
Canada	CARE Site 03	Saskatoon	Saskatchewan
Canada	CARE Site 47	Sherbrooke	Quebec
Canada	CARE Site 28	Sherwood Park	Alberta
Canada	CARE Site 06	Sudbury	Ontario
Canada	CARE Site 16	Toronto	Ontario
Canada	CARE Site 49	Toronto	Ontario
Canada	CARE Site 31	Vancouver	British Columbia
Canada	CARE Site 40	Westmount	Quebec
Canada	CARE Site 32	Whitby	Ontario
Canada	CARE Site 12	Winnipeg	Manitoba
Canada	CARE Site 36	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The number and percentage of Adverse Events (AEs) or (Serious Adverse Events) SAEs reported over 12 months post-brodalumab initiation.		12 months
Secondary	Reasons for discontinuation of brodalumab therapy.	Discontinuation reason is captured on the case report form.	12 months
Secondary	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
Secondary	The mean and median time to brodalumab discontinuation.		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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