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")

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Diagnostic test: PEST Screening group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 502
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • Novartis Investigative Site
    • Edmonton, Alberta, Canada, T6G 2C8
      • Recruiting
      • Novartis Investigative Site
    • Edmonton, Alberta, Canada, T5J 3S9
      • Recruiting
      • Novartis Investigative Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 4V5
      • Recruiting
      • Novartis Investigative Site
    • Surrey, British Columbia, Canada, V3R 6A7
      • Recruiting
      • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Recruiting
      • Novartis Investigative Site
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Recruiting
      • Novartis Investigative Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Recruiting
      • Novartis Investigative Site
    • Greater Sudbury, Ontario, Canada, P3C 1X8
      • Recruiting
      • Novartis Investigative Site
    • Hamilton, Ontario, Canada, L8N 1V6
      • Recruiting
      • Novartis Investigative Site
    • Hamilton, Ontario, Canada, L8J 0G5
      • Recruiting
      • Novartis Investigative Site
    • Hamilton, Ontario, Canada, L8P4B4
      • Recruiting
      • Novartis Investigative Site
    • London, Ontario, Canada, N6A 5R9
      • Recruiting
      • Novartis Investigative Site
    • London, Ontario, Canada, N6G 0W7
      • Recruiting
      • Novartis Investigative Site
    • Markham, Ontario, Canada, L3R 2C7
      • Recruiting
      • Novartis Investigative Site
    • North York, Ontario, Canada, M3B 3N1
      • Recruiting
      • Novartis Investigative Site
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Recruiting
      • Novartis Investigative Site
    • Stoney Creek, Ontario, Canada, L8G 1H1
      • Recruiting
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5S 1B6
      • Recruiting
      • Novartis Investigative Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Recruiting
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H4A 3T2
      • Recruiting
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H1Y 3L1
      • Recruiting
      • Novartis Investigative Site
    • Québec, Quebec, Canada, G1W 4R4
      • Recruiting
      • Novartis Investigative Site
    • Québec, Quebec, Canada, G1V 4X7
      • Recruiting
      • Novartis Investigative Site
    • Ste-Foy, Quebec, Canada, G1V 4G2
      • Recruiting
      • Novartis Investigative Site
    • Verdun, Quebec, Canada, H4G 3E7
      • Recruiting
      • Novartis Investigative Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Recruiting
      • Novartis Investigative Site
    • Saskatoon, Saskatchewan, Canada, S7K0H6
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key inclusion criteria:

1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.
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.
2. Patients who have been diagnosed with PsA.
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 within the last 6 months prior to patient enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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: Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions; 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; 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.

Diagnostic test: PEST Screening group; PEST Screening group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 1 year
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: 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)	Up to approximately 1 year
Proportion of patients with a false positive score between each group	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	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	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.	Up to approximately 1 year
Patient acceptability/user experience of the PEST+2 questionnaire	Summary scores of the patient acceptability questionnaire of PsA screening questionnaires and a categorical presentation of question-by-question responses at Visit 1	Up to approximately 1 year
Administration of dermatologist quantitative surveys	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	Up to approximately 1 year
Qualitative interview with selected dermatologists	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)	Up to approximately 1 year
Intervention Appropriateness Measure (IAM)	To assess the appropriateness of the PEST+2 from the perspective of rheumatologists	Up to approximately 1 year

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Psoriatic Arthritis; PsA; Plaque Psoriasis; Implementation Science; PsO; Psoriasis Epidemiology Screening Tool
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Skin and Connective Tissue Diseases; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: CAIN457ACA06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No