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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEST Screening group | Other | When visiting their dermatologists, all eligible patients with moderate-to-severe plaque psoriasis (PsO) eligible for treatment with biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) will be screened for psoriatic arthritis (PsA) using PEST+pictures+2, a variation of the PEST screening tool. The PEST+pictures+2 is made up of 3 components:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEST Screening group | Diagnostic Test | PEST Screening group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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? | Up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to approximately 1 year |
| Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | novartis.email@novartis.com |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Calgary | Alberta | T2J 7E1 | Canada | |
| Novartis Investigative Site |
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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Proportion of patients with a new PsA diagnosis or suspicion of PsA, confirmed by the rheumatologist who scored:
|
| 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:
| 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 | 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. | 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 | 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 | 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) | Up to approximately 1 year |
| Intervention Appropriateness Measure (IAM) | To assess the appropriateness of the PEST+2 from the perspective of rheumatologists | Up to approximately 1 year |
| Recruiting |
| Edmonton |
| Alberta |
| T5J 3S9 |
| Canada |
| Novartis Investigative Site | Recruiting | Edmonton | Alberta | T6G 2C8 | Canada |
| Novartis Investigative Site | Recruiting | Kelowna | British Columbia | V1W 4V5 | Canada |
| Novartis Investigative Site | Recruiting | Surrey | British Columbia | V3R 6A7 | Canada |
| Novartis Investigative Site | Recruiting | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Novartis Investigative Site | Recruiting | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Novartis Investigative Site | Recruiting | Barrie | Ontario | L4M 6L2 | Canada |
| Novartis Investigative Site | Recruiting | Greater Sudbury | Ontario | P3C 1X8 | Canada |
| Novartis Investigative Site | Recruiting | Hamilton | Ontario | L8J 0G5 | Canada |
| Novartis Investigative Site | Recruiting | Hamilton | Ontario | L8N 1V6 | Canada |
| Novartis Investigative Site | Recruiting | Hamilton | Ontario | L8P4B4 | Canada |
| Novartis Investigative Site | Recruiting | London | Ontario | N6A 5R9 | Canada |
| Novartis Investigative Site | Recruiting | London | Ontario | N6G 0W7 | Canada |
| Novartis Investigative Site | Recruiting | Markham | Ontario | L3R 2C7 | Canada |
| Novartis Investigative Site | Recruiting | Ottawa | Ontario | K2A 3Z3 | Canada |
| Novartis Investigative Site | Recruiting | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Novartis Investigative Site | Recruiting | Stoney Creek | Ontario | L8G 1H1 | Canada |
| Novartis Investigative Site | Recruiting | Toronto | Ontario | M4A2S8 | Canada |
| Novartis Investigative Site | Recruiting | Toronto | Ontario | M5S 1B6 | Canada |
| Novartis Investigative Site | Recruiting | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Recruiting | Montreal | Quebec | H1Y 3L1 | Canada |
| Novartis Investigative Site | Recruiting | Montreal | Quebec | H4A 3T2 | Canada |
| Novartis Investigative Site | Recruiting | Québec | Quebec | G1V 4X7 | Canada |
| Novartis Investigative Site | Recruiting | Québec | Quebec | G1W 4R4 | Canada |
| Novartis Investigative Site | Recruiting | Ste-Foy | Quebec | G1V 4G2 | Canada |
| Novartis Investigative Site | Recruiting | Verdun | Quebec | H4G 3E7 | Canada |
| Novartis Investigative Site | Recruiting | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| Novartis Investigative Site | Recruiting | Saskatoon | Saskatchewan | S7K0H6 | Canada |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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