Plaque Psoriasis, Psoriatic Arthritis
Conditions
Keywords
Psoriasis, Psoriatic Arthritis, PsA, Plaque Psoriasis, PsO, Implementation Science, Psoriasis Epidemiology Screening Tool
Brief summary
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.
Detailed description
Patients will be enrolled in the study for up to 120 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.
Interventions
DIAGNOSTIC_TESTPEST Screening group
PEST Screening group
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria: 1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment. 2. Adult patients at the time of informed consent signature 3. Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions 4. Residents of Canada Key
Exclusion criteria
1. Patients who have previously screened positive for PsA through PEST. 2. Patients who have been diagnosed with PsA. 3. Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis) 4. Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs | Up to approximately 1 year | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to approximately 1 year | To estimate the proportion of patients with a confirmed or suspected PsA diagnosis referred by dermatologists using PEST+2 only |
| Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist | Up to approximately 1 year | 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) |
| Proportion of patients with a false positive score between each group | Up to approximately 1 year | 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 |
| Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests | Up to approximately 1 year | 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. |
| Patient acceptability/user experience of the PEST+2 questionnaire | Up to approximately 1 year | Summary scores of the patient acceptability questionnaire of PsA screening questionnaires and a categorical presentation of question-by-question responses at Visit 1 |
| Administration of dermatologist quantitative surveys | Up to approximately 1 year | 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 |
| Qualitative interview with selected dermatologists | Up to approximately 1 year | 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) |
| Intervention Appropriateness Measure (IAM) | Up to approximately 1 year | To assess the appropriateness of the PEST+2 from the perspective of rheumatologists |
Countries
Canada
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed