PsoriasisCARENCT05132231
Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
An observational study of Psoriasis, run by Bausch Health Americas, Inc. at 42 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Brodalumab and Matched cohort
- How many people
- 394 participants
- Where
- 42 sitesCanada
- Study dates
- 22 Oct 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Canada42 sites
CARE Site 11
Ajax, Ontario, L1S 7K8
CARE Site 05
Barrie, Ontario, L4M 7G1
CARE Site 42
Calgary, Alberta, T2J 7E1
CARE Site 26
Calgary, Alberta, T2W 4X9
CARE Site 15
Calgary, Alberta, T5J 3S9
CARE Site 38
Drummondville, Quebec, J2B 5L4
CARE Site 18
Edmonton, Alberta, T5J 3S9
CARE Site 41
Edmonton, Alberta, T6G 1C3
CARE Site 21
Edmonton, Alberta, T6W 0J5
CARE Site 37
Edmonton, Alberta, T6X 0N9
CARE Site 06
Greater Sudbury, Ontario, P3C 1XB
CARE Site 20
Guelph, Ontario, N1L 0B7
CARE Site 14
Hamilton, Ontario, L8N 1Y2
CARE Site 24
Hamilton, Ontario, L9B 1K5
CARE Site 07
Laval, Quebec, H7N 6L2
CARE Site 50
Laval, Quebec, H7P K7
CARE Site 23
London, Ontario, N6A 2C2
CARE Site 22
London, Ontario, N6A 5R9
CARE Site 09
London, Ontario, N6H 5L6
CARE Site 33
Markham, Ontario, L3P 1X3
CARE Site 44
Mississauga, Ontario, L4W 0C2
CARE Site 04
Montreal, Quebec, H2E 1V4
CARE Site 51
Niagara Falls, Ontario, L2E 6A6
CARE Site 48
North York, Ontario, M3B 0A7
CARE Site 27
Oshawa, Ontario, L1H 1B9
CARE Site 46
Québec, Quebec, G1V T3
CARE Site 30
Québec, Quebec, G1W 4R4
CARE Site 17
Québec, Quebec, G3K 2P8
CARE Site 13
Richmond Hill, Ontario, L4C 9M7
CARE Site 35
Saint Johns, Newfoundland and Labrador, A1E 1V4
CARE Site 52
Saint-Charles-Borromée, Quebec, J6E 4P6
CARE Site 39
Saint-Jérôme, Quebec, J7Z 7E2
CARE Site 03
Saskatoon, Saskatchewan, S7T 0G3
CARE Site 47
Sherbrooke, Quebec, J1L 0H8
CARE Site 28
Sherwood Park, Alberta, T8H 0P1
CARE Site 49
Toronto, Ontario, M2N 3A6
CARE Site 16
Toronto, Ontario, M5A 3R6
CARE Site 31
Vancouver, British Columbia, V5Z 1M9
CARE Site 40
Westmount, Quebec, H3Z 2S6
CARE Site 32
Whitby, Ontario, L1N 8M7
CARE Site 36
Winnipeg, Manitoba, R3C 0N2
CARE Site 12
Winnipeg, Manitoba, R3M 3Z4
About this study
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
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
- Being tested
- Brodalumab, Matched cohort
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabBiological
Brodalumab
Matched cohortBiological
Matched cohort
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab initiator | Eligible adult participants who are enrolling into the SILIQ (brodalumab) Patient Support Program (PSP) and initiating brodalumab as per routine care. Receives: 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. Receives: Biological: Matched cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Key demographics and clinical characteristics include: prior biologic experience, age, gender, province, disease duration, number of comorbidities.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 months
Reasons for discontinuation of brodalumab therapy.
Discontinuation reason is captured on the case report form.
Measured: 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.
Measured: 12 months
The mean and median time to brodalumab discontinuation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start22 Oct 2021
- Primary completion5 Feb 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Barbeau, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132231
- Sponsor's protocol ID
- BHC-CANDerm-003
- Acronym
- CARE
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05132231
- Acronym / sponsor ID
- CARE / BHC-CANDerm-003
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brodalumab initiator | – | Biological: BrodalumabEligible adult participants who are enrolling into the SILIQ (brodalumab) Patient Support Program (PSP) and initiating brodalumab as per routine care. |
| Matched cohort | – | Biological: Matched cohortParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrodalumabBrodalumab | Biological | Brodalumab initiator |
| Matched cohortMatched cohort | Biological | Matched cohort |
Primary outcome
The percentage change from baseline of the Dermatology Life Quality Index (DLQI) at 3 months, 6 months, and 12 months post-brodalumab initiation.
Time frame: baseline, 3 months, 6 months, 12 months
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.
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.
Time frame: baseline, 3 months, 6 months, 12 months
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.
The percentage change from baseline of the Health Utility Index (HUI2) at 3 months, 6 months, and 12 months post-brodalumab initiation.
Time frame: baseline, 3 months, 6 months, 12 months
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.
The mean Treatment Satisfaction Questionnaire for Medication (TSQM) domain scores at baseline, 3 months, 6 months, and 12 months post-brodalumab initiation.
Time frame: baseline, 3 months, 6 months, 12 months
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).
25 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Reasons for discontinuation of brodalumab therapy.
Time frame: 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.
Time frame: 12 months
The mean and median time to brodalumab discontinuation.
Time frame: 12 months
The number of patients encountering psoriasis-related physician
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering psoriasis-related physician
Time frame: baseline, 3 months, 6 months, 12 months
The number of patients encountering hospital visit
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering hospital visit
Time frame: baseline, 3 months, 6 months, 12 months
The number of patients encountering emergency room (ER) visits
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering emergency room (ER) visits
Time frame: baseline, 3 months, 6 months, 12 months
The number of patients encountering psoriasis-related procedures
Time frame: baseline, 3 months, 6 months, 12 months
Associated costs of patients encountering psoriasis-related procedures
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Barbeau study director
Bausch Health Americas, Inc.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Bausch Health Americas, Inc. at 42 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change from baseline of the Dermatology Life Quality Index (DLQI) at 3 months, 6 months, and 12 months post-brodalumab initiation. (time frame: baseline, 3 months, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.