Modifying PEST for Psoriatic Arthritis Screening
- Conditions
- Plaque PsoriasisPsoriatic Arthritis
- Interventions
- Diagnostic Test: PEST Screening group
- Registration Number
- NCT06382051
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 502
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEST Screening group PEST Screening group 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: 1. Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions 2. PEST+2 refers to the PEST modified with two additional questions (Do you have morning stiffness that lasts for more than one (1) hour? Do you wake up at night because of low back or buttock pain?), AND 3. PEST+pictures which provides an opportunity for patients to modify their answers to PEST questions 1, 3, and 5 by presenting them with pictures of swollen joints, fingernail pitting, and swollen fingers and toes.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Intervention Appropriateness Measure (IAM) Up to approximately 1 year To assess the appropriateness of the PEST+2 from the perspective of rheumatologists
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. PESTQualitative 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)
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
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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇦Stoney Creek, Ontario, Canada