Modifying PEST for Psoriatic Arthritis Screening
ScreenX
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")
1 other identifier
interventional
502
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 28, 2026
April 29, 2026
March 1, 2026
1.6 years
April 19, 2024
April 24, 2026
Conditions
Keywords
Outcome Measures
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?
Up to approximately 1 year
Secondary Outcomes (8)
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
Up to approximately 1 year
Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Up to approximately 1 year
Proportion of patients with a false positive score between each group
Up to approximately 1 year
Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
Up to approximately 1 year
Patient acceptability/user experience of the PEST+2 questionnaire
Up to approximately 1 year
- +3 more secondary outcomes
Study Arms (1)
PEST Screening group
OTHERWhen 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Novartis Investigative Site
Calgary, Alberta, T2J 7E1, Canada
Novartis Investigative Site
Kelowna, British Columbia, V1W 4V5, Canada
Novartis Investigative Site
Surrey, British Columbia, V3R 6A7, Canada
Novartis Investigative Site
Winnipeg, Manitoba, R3C 0N2, Canada
Novartis Investigative Site
Fredericton, New Brunswick, E3B 1G9, Canada
Novartis Investigative Site
Hamilton, Ontario, L8J 0G5, Canada
Novartis Investigative Site
Hamilton, Ontario, L8N 1V6, Canada
Novartis Investigative Site
Hamilton, Ontario, L8P4B4, Canada
Novartis Investigative Site
Markham, Ontario, L3R 2C7, Canada
Novartis Investigative Site
North York, Ontario, M3B 3N1, Canada
Novartis Investigative Site
Richmond Hill, Ontario, L4C 9M7, Canada
Novartis Investigative Site
Stoney Creek, Ontario, L8G 1H1, Canada
Novartis Investigative Site
Toronto, Ontario, M5S 1B6, Canada
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4, Canada
Novartis Investigative Site
Montreal, Quebec, H1Y 3L1, Canada
Novartis Investigative Site
Montreal, Quebec, H4A 3T2, Canada
Novartis Investigative Site
Québec, Quebec, G1V 4X7, Canada
Novartis Investigative Site
Ste-Foy, Quebec, G1V 4G2, Canada
Novartis Investigative Site
Verdun, Quebec, H4G 3E7, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, S7K 2C1, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, S7K0H6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2024
First Posted
April 24, 2024
Study Start
January 23, 2025
Primary Completion (Estimated)
August 28, 2026
Study Completion (Estimated)
August 28, 2026
Last Updated
April 29, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.