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NCT Number: NCT06382051

Modifying PEST for Psoriatic Arthritis Screening

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.

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Key information

Conditions

Plaque Psoriasis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Investigative Site, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key inclusion criteria:

  • 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

Key exclusion criteria:

  • 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.

Treatment and study plan

PEST Screening group

Diagnostic Test

PEST Screening group

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

    Time frame: 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 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

    Time frame: 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

  2. Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist

    Time frame: Up to approximately 1 year

    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)

  3. Proportion of patients with a false positive score between each group

    Time frame: Up to approximately 1 year

    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

  4. Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests

    Time frame: 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.

  5. Patient acceptability/user experience of the PEST+2 questionnaire

    Time frame: 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

  6. Administration of dermatologist quantitative surveys

    Time frame: 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

  7. Qualitative interview with selected dermatologists

    Time frame: 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)

  8. Intervention Appropriateness Measure (IAM)

    Time frame: Up to approximately 1 year

    To assess the appropriateness of the PEST+2 from the perspective of rheumatologists

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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")

Acronym: ScreenX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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