Modifying PEST for Psoriatic Arthritis Screening

Psoriatic Arthritis Clinical Trial

— ScreenX  

Official title:

A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada ("ScreenX")

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382051
• Other study ID #: CAIN457ACA06
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 28, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 502
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Key inclusion criteria:

1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, as per provincial reimbursement criteria

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 or any other screening method

2. Patients who have been diagnosed with PsA and/or followed by a rheumatologist

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis

Intervention

Diagnostic Test:
• PEST Screening group
PEST Screening group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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: Negative on PEST and positive on PEST+pictures; 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)	Up to approximately 1 year
Secondary	Proportion of patients with a false positive score between each group	Proportion of patients with false positive score between each group will be evaluated: PEST+2 vs. PEST+pictures+2; PEST+pictures vs. PEST; PEST+pictures+2 vs. PEST	Up to approximately 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intervention Appropriateness Measure (IAM)	To assess the appropriateness of the PEST+2 from the perspective of rheumatologists	Up to approximately 1 year