Clinical trial NCT06382051: Modifying PEST for Psoriatic Arthritis Screening
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")
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plaque Psoriasis
Psoriatic Arthritis
Keywords: Psoriasis
Psoriatic Arthritis
PsA
Plaque Psoriasis
PsO
Implementation Science
Psoriasis Epidemiology Screening Tool
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-04-24
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
timeFrame: Up to approximately 1 year
Secondary outcomes:
measure: 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
timeFrame: Up to approximately 1 year
measure: Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
timeFrame: Up to approximately 1 year
measure: Proportion of patients with a false positive score between each group
timeFrame: Up to approximately 1 year
measure: Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
timeFrame: Up to approximately 1 year
measure: Patient acceptability/user experience of the PEST+2 questionnaire
timeFrame: Up to approximately 1 year
measure: Administration of dermatologist quantitative surveys
timeFrame: Up to approximately 1 year
measure: Qualitative interview with selected dermatologists
timeFrame: Up to approximately 1 year
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Stoney Creek
country: Canada
facility: Novartis Investigative Site
state: Ontario
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: