Modifying PEST for Psoriatic Arthritis Screening

NCT ID: NCT06382051

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Plaque Psoriasis Psoriatic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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PEST Screening group

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.

Group Type OTHER

PEST Screening group

Intervention Type DIAGNOSTIC_TEST

PEST Screening group

Interventions

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PEST Screening group

PEST Screening group

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Kelowna, British Columbia, Canada

Site Status RECRUITING

Novartis Investigative Site

Fredericton, New Brunswick, Canada

Site Status RECRUITING

Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Markham, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Richmond Hill, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Stoney Creek, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Waterloo, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Québec, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Ste-Foy, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Novartis Investigative Site

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CAIN457ACA06

Identifier Type: -

Identifier Source: org_study_id

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