PsA Screening Questionnaire for Psoriatic Arthritis

Recruiting at 1 trial location

Overseen By Alexis Ogdie, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jessica Walsh

Disqualifiers: Psoriatic arthritis diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a new method for early detection of Psoriatic Arthritis (PsA) in individuals with psoriasis. Instead of requiring a doctor's visit, the study will test a questionnaire sent directly to patients. Participants will either receive the PsA Screening Questionnaire (also known as the Psoriasis Epidemiology Screening Tool or the Toronto Psoriatic Arthritis Screen) with instructions to consult their doctor or gain direct access to a rheumatologist (a joint and muscle specialist). The study seeks individuals with psoriasis who have not been diagnosed with PsA. As an unphased trial, this study offers a unique opportunity to contribute to early detection methods for PsA, potentially benefiting many in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this screening questionnaire is safe for patients?

Research has shown that screening questionnaires for Psoriatic Arthritis (PsA) are generally safe. Tools like the Psoriasis Epidemiology Screening Tool (PEST) help identify signs of PsA without a doctor's involvement. As they do not involve physical treatment, they pose no risk of side effects.

These questionnaires ask about symptoms you might experience. Studies have found that these tools can aid in early detection of PsA, which is crucial for managing the condition. Therefore, completing these questionnaires is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to identify psoriatic arthritis (PsA) early in patients with psoriasis. Unlike the standard of care, which often relies on patients reporting symptoms and doctors' assessments, this trial introduces a direct-to-patient screening questionnaire. This method aims to empower patients by encouraging them to discuss their results with a doctor or even directly schedule with a rheumatologist. By potentially catching PsA earlier, this approach could lead to faster treatment and better outcomes for patients.

What evidence suggests that this screening questionnaire is effective for early PsA detection?

Research has shown that screening tools like the Psoriasis Epidemiology Screening Tool (PEST) can help detect Psoriatic Arthritis (PsA) early. These questionnaires accurately identify PsA in people with psoriasis. In one study, about 30% of psoriasis patients were diagnosed with PsA after using these tools. The Toronto Psoriatic Arthritis Screening tool has also proven effective in identifying PsA. In this trial, some participants will receive an intervention PsA questionnaire with instructions to discuss a referral to a rheumatologist with their doctor, while others will receive instructions on how to directly schedule a rheumatologic evaluation. These tools provide a practical way for patients to understand their risk and seek treatment sooner. ^{2 4 5 6 7}

Who Is on the Research Team?

Jessica Walsh, M.D.

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a diagnosis of psoriasis who haven't been diagnosed with Psoriatic Arthritis. Participants should live close to the study site and have not started any treatment for Psoriatic Arthritis.

Inclusion Criteria

I have been diagnosed with psoriasis but not with psoriatic arthritis.

Be geographically located within a reasonable proximity to the Rheumatology study site

Exclusion Criteria

I have psoriasis and a rheumatologist confirmed I also have psoriatic arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a PsA screening questionnaire and are either instructed to talk with their doctor about a rheumatology referral or given direct access to schedule a rheumatologic evaluation.

6 months

Follow-up

Participants are monitored for new PsA diagnoses and rheumatologic evaluations, as well as disease severity and activity.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Direct to patient PsA Screening Questionnaire

Trial Overview The study is testing a new way to find out if people with psoriasis might also have Psoriatic Arthritis using a questionnaire that patients can fill out on their own, without needing to visit doctors' offices.

How Is the Trial Designed?

Group I: Intervention with Standard of Care Referral Experimental Treatment 1 Intervention

Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions to talk with their doctor about a referral to a rheumatologist

Group II: Intervention with Direct Access to Rheumatologist Experimental Treatment 1 Intervention

Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation

Group III: Control Active Control 1 Intervention

Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire

Who Is Running the Clinical Trial?

Jessica Walsh

Lead Sponsor

Trials

1

Recruited

18,000+

Published Research Related to This Trial

In a study of 1516 patients with psoriasis, 12.4% of those without a reported diagnosis of psoriatic arthritis (PsA) scored 3 or higher on the Psoriasis Epidemiology Screening Tool (PEST), indicating a potential risk for undiagnosed PsA.

Patients with PEST scores ≥3 were generally older, more likely to be female, and reported worse health outcomes, including higher levels of pain and fatigue, highlighting the need for improved screening for PsA in psoriasis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of the validated Psoriasis Epidemiology Screening Tool to identify signs and symptoms of psoriatic arthritis among those with psoriasis: a cross-sectional analysis from the US-based Corrona Psoriasis Registry. Mease, PJ., Palmer, JB., Hur, P., et al.[2020]

The Toronto Psoriatic Arthritis Screen, version 2 (ToPAS 2), effectively identifies psoriasis through skin-specific questions, achieving high specificity (82% to 92%) and sensitivity (69% to 84%) in a study of 258 participants.

The screening tool shows excellent negative predictive value (>95%), indicating it can reliably rule out psoriasis, making it a valuable resource in settings with limited access to dermatologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Toronto Psoriatic Arthritis Screen 2 as a Screening Tool for Psoriasis. Taylor, JH., Deo, M., Sutton, M., et al.[2022]

The Turkish version of the SiPAS questionnaire is highly effective for screening psoriatic arthritis (PsA) in patients with psoriasis (PsO), demonstrating an excellent area under the ROC curve of 0.994.

With a sensitivity of 97.6% and specificity of 94.3%, a SiPAS score of 3 or higher indicates a strong need for referral to a rheumatologist, making it a valuable tool for early detection and prevention of joint damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Simple Psoriatic Arthritis Screening (SiPAS) questionnaire in a Turkish psoriatic population. Kaymaz, S., Karasu, U., Kaçar, N., et al.[2021]

The Toronto Psoriatic Arthritis Screen 2 (ToPAS 2) has been validated as an effective screening tool for psoriatic arthritis (PsA), achieving a high area under the receiver-operating curve of 0.910, indicating strong diagnostic performance.

ToPAS 2 demonstrated excellent sensitivity (87.2%) and specificity (82.7%) for identifying PsA, particularly incorporating axial involvement, making it a promising option for screening in both psoriasis patients and the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Toronto Psoriatic Arthritis Screen Version 2 (ToPAS 2). Tom, BD., Chandran, V., Farewell, VT., et al.[2022]

The Toronto Psoriatic Arthritis Screening questionnaire (ToPAS) was created to effectively screen for psoriatic arthritis (PsA) in both patients with psoriasis and the general population, making it a versatile tool for epidemiological studies.

Initial comparisons showed that ToPAS performs well against the established Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire, indicating its potential reliability, although further modifications and validations are still in progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toronto Psoriatic Arthritis Screening (ToPAS) questionnaire: a report from the GRAPPA 2009 annual meeting. Chandran, V., Gladman, DD.[2015]

In a study of 200 patients, 29% of psoriasis patients attending dermatology clinics were found to have undiagnosed psoriatic arthritis (PsA), highlighting the need for better screening in this population.

The severity of psoriasis was positively associated with the likelihood of a new PsA diagnosis, and the screening questionnaires used had low sensitivity, particularly for detecting non-polyarticular forms of arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High prevalence of psoriatic arthritis in patients with severe psoriasis with suboptimal performance of screening questionnaires. Haroon, M., Kirby, B., FitzGerald, O.[2022]

The Psoriasis Epidemiology Screening Tool (PEST) is a simple and effective screening tool for identifying psoriatic arthritis (PsA) in patients with psoriasis, showing a high sensitivity of 0.94 and a specificity of 0.78 during its development.

A future study will compare the PEST with other screening tools like ToPAS and PASE in a secondary-care population, aiming to validate its effectiveness and confirm its high sensitivity in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psoriasis Epidemiology Screening Tool (PEST): a report from the GRAPPA 2009 annual meeting. Helliwell, PS.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6593969/

Utilization of the validated Psoriasis Epidemiology Screening ... The validated Psoriasis Epidemiology Screening Tool (PEST) is a five‐item questionnaire developed to help identify PsA at an early stage.

2. elsevier.es elsevier.es/es-revista-revista-colombiana-reumatologia-english-edition--474-articulo-validation-toronto-psoriatic-arthritis-screening-S244444052300095X

Validation of the Toronto Psoriatic Arthritis Screening 2 ... The ToPAS-2 questionnaire proved to be a valid, sensitive, and specific tool for the detection of PsA in patients with psoriasis.

3. psoriasis.org psoriasis.org/psoriatic-arthritis-screening-test/

Psoriatic Arthritis Screening Test The Psoriasis Epidemiology Screening Tool (PEST) is a validated screening tool for psoriatic arthritis.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962214014388

Comparative performance of psoriatic arthritis screening ... Of 949 patients with psoriasis evaluated by rheumatologists, 285 (30%) received a clinical diagnosis of PsA (95% confidence interval 27%-33%). Probable PsA was ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/assessing-the-accuracy-of-questionnaire-based-screening-tools-for-detection-of-psoriatic-arthritis/

Assessing the Accuracy of Questionnaire-Based Screening ... Questionnaire-based screening tools have demonstrated moderate accuracy to detect psoriatic arthritis (PsA) in patients with psoriasis ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18445625/

the Toronto Psoriatic Arthritis Screen (ToPAS) Objective: To develop and validate a psoriatic arthritis (PsA) screening questionnaire: the Toronto Psoriatic Arthritis Screen (ToPAS).

7. withpower.com withpower.com/trial/phase-arthritis-6-2019-0174b

PsA Screening Questionnaire for Psoriatic Arthritis The overarching goal of this study is to develop a direct-to-patient screening approach that will improve early Psoriatic Arthritis (PsA) detection in ...