Modifying PEST for Psoriatic Arthritis Screening (ScreenX)

Novartis

Status: Enrolling

Conditions: Plaque Psoriasis; Psoriatic Arthritis

Treatments: Diagnostic Test: PEST Screening group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06382051

CAIN457ACA06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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502 participants in 1 patient group

PEST Screening group

Other group

Description:

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.

Treatment:

Diagnostic Test: PEST Screening group