Improving Psoriatic Arthritis Screening for Patients with Plaque Psoriasis
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")
This study is testing a new way to help doctors spot psoriatic arthritis earlier in patients with plaque psoriasis by adding extra questions and images to a screening tool.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 502 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 21 sites (Calgary, Alberta and 20 other locations) |
| Trial ID | NCT06382051 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the screening process for psoriatic arthritis (PsA) by adding two questions and images to the existing PEST questionnaire for patients with moderate-to-severe plaque psoriasis. Participants will complete the screening at their first dermatologist visit, and those who screen positive will undergo a comprehensive diagnostic assessment by a rheumatologist. The study will track treatment choices and status through a remote follow-up visit with the dermatologist. The goal is to improve early diagnosis and treatment pathways for patients with PsA.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with moderate-to-severe plaque psoriasis who are eligible for biologic DMARDs.
Not a fit: Patients who have already been diagnosed with psoriatic arthritis or have inflammatory arthritis unrelated to PsA will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of psoriatic arthritis in patients with plaque psoriasis, improving their treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving screening methods for related conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Calgary, Alberta and 20 other locations
- Novartis Investigative Site — Calgary, Alberta, Canada (Recruiting)
- Novartis Investigative Site — Kelowna, British Columbia, Canada (Recruiting)
- Novartis Investigative Site — Surrey, British Columbia, Canada (Recruiting)
- Novartis Investigative Site — Winnipeg, Manitoba, Canada (Recruiting)
- Novartis Investigative Site — Fredericton, New Brunswick, Canada (Recruiting)
- Novartis Investigative Site — Hamilton, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Hamilton, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Hamilton, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Markham, Ontario, Canada (Recruiting)
- Novartis Investigative Site — North York, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Richmond Hill, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Stoney Creek, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Toronto, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Waterloo, Ontario, Canada (Recruiting)
- Novartis Investigative Site — Montreal, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Montreal, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Québec, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Ste-Foy, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Verdun, Quebec, Canada (Recruiting)
- Novartis Investigative Site — Saskatoon, Saskatchewan, Canada (Recruiting)
- Novartis Investigative Site — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.