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Modifying PEST for Psoriatic Arthritis Screening
NCT06382051 · Novartis
In plain English
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Official 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")
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.
Eligibility criteria
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 design
Enrollment target: 502 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-23
Estimated completion: 2026-12-31
Last updated: 2026-09-09
Interventions
Diagnostic Test: PEST Screening group
Primary outcomes
- • Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs (Up to approximately 1 year)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (30)
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Fredericton, New Brunswick, Canada
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Barrie, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Ottawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Stoney Creek, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Verdun, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
Novartis Investigative SiteRecruiting
Saskatoon, Saskatchewan, Canada