The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
Patients will be enrolled in the study for up to 66 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
502
PEST Screening group
Novartis Investigative Site
Kelowna, British Columbia, Canada
RECRUITINGNovartis Investigative Site
Surrey, British Columbia, Canada
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
To assess the impact of adding two questions (morning stiffness and low back or buttock pain) to the validated PEST for the potential diagnosis of PsA in moderate-to-severe plaque PsO patients who are candidates for biologic disease-modifying antirheumatic drugs (bDMARDs) The primary clinical question of interest is: Can the addition of two questions to PEST pertaining to presence of morning stiffness and low back or buttock pain (i.e., PEST+2) allow for improved screening and diagnosis of PsA in patients with moderate-to-severe plaque PsO?
Time frame: Up to approximately 1 year
Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
To estimate the proportion of patients with a confirmed or suspected PsA diagnosis referred by dermatologists using PEST+2 only
Time frame: Up to approximately 1 year
Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Proportion of patients with a new PsA diagnosis or suspicion of PsA, confirmed by the rheumatologist who scored: 1. Negative on PEST and positive on PEST+pictures 2. Negative on PEST+2 and positive on PEST+pictures+2 will be evaluated to assess the impact of adding pictures as reference to guide patients answering the screening questions (question 1, 3, and 5)
Time frame: Up to approximately 1 year
Proportion of patients with a false positive score between each group
Proportion of patients with false positive score between each group will be evaluated: 1. PEST+2 vs. PEST+pictures+2 2. PEST+pictures vs. PEST 3. PEST+pictures+2 vs. PEST
Time frame: Up to approximately 1 year
Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Fredericton, New Brunswick, Canada
RECRUITINGNovartis Investigative Site
Hamilton, Ontario, Canada
RECRUITINGNovartis Investigative Site
Hamilton, Ontario, Canada
RECRUITINGNovartis Investigative Site
Hamilton, Ontario, Canada
RECRUITINGNovartis Investigative Site
Markham, Ontario, Canada
RECRUITINGNovartis Investigative Site
Richmond Hill, Ontario, Canada
RECRUITINGNovartis Investigative Site
Stoney Creek, Ontario, Canada
RECRUITINGNovartis Investigative Site
Waterloo, Ontario, Canada
RECRUITING...and 5 more locations
Description of the baseline characteristics (i.e., patient age, biological sex, years since plaque PsO diagnosis, medical history, disease characteristics, concomitant treatments, height, weight, etc.) of the positive screening score and negative screening score patients for both PEST and PEST+2 tests will be evaluated to determine patient's baseline characteristics.
Time frame: Up to approximately 1 year
Patient acceptability/user experience of the PEST+2 questionnaire
Summary scores of the patient acceptability questionnaire of PsA screening questionnaires and a categorical presentation of question-by-question responses at Visit 1
Time frame: Up to approximately 1 year
Administration of dermatologist quantitative surveys
Administration of dermatologist quantitative surveys, as well as open-ended qualitative questions to assess the acceptability and feasibility of the PEST+pictures+2 from the perspective of dermatologists
Time frame: Up to approximately 1 year
Qualitative interview with selected dermatologists
Brief 1:1 qualitative interview with selected dermatologists (maximum 12) to assess their knowledge, beliefs, and attitudes towards PsA screening (e.g., motivation to screen)
Time frame: Up to approximately 1 year
Intervention Appropriateness Measure (IAM)
To assess the appropriateness of the PEST+2 from the perspective of rheumatologists
Time frame: Up to approximately 1 year