Modifying PEST for Psoriatic Arthritis Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.
Adult patients at the time of informed consent signature
Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions
Residents of Canada
Disqualifiers
Patients who have previously screened positive for PsA through PEST.
Patients who have been diagnosed with PsA.
Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)
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.
Trial design
Design model
Single group
Treatments tested in this trial
PEST Screening group
Diagnostic testPEST Screening group
Treatment groups
502 Participants
are divided into 1 treatment groupGroup A: PEST Screening groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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?
Time frame
Up to approximately 1 yearSecondary outcomes
1
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
Time frame
Up to approximately 1 year2
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: 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)
Time frame
Up to approximately 1 year3
Proportion of patients with a false positive score between each group
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
Time frame
Up to approximately 1 year4
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.
Time frame
Up to approximately 1 yearSponsors and contacts
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Source ClinicalTrials.gov