PsA Screening Questionnaire for Psoriatic Arthritis

Recruiting at 1 trial location

Overseen By Jessica Walsh, 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

Trial Summary

What is the purpose of this trial?

The overarching goal of this study is to develop a direct-to-patient screening approach that will improve early Psoriatic Arthritis (PsA) detection in patients with psoriasis. Previously developed screening questionnaires were intended for use in the setting of a doctor's office to assist providers with referral decisions. However, these screening questionnaires are infrequently used in routine practice because of limitations with time and resources. The study will aim to develop a practical screening strategy that does not require involvement from dermatologists (or other non-rheumatology providers) and can systematically reach a broad range of psoriasis patients, including patients not attending dermatology clinics. The researchers hypothesize that disseminating questionnaires directly to patients outside of a clinic setting (direct-to-patient approach) will educate patients about their PsA risk and improve early PsA diagnoses.

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 data supports the effectiveness of the PsA Screening Questionnaire for Psoriatic Arthritis treatment?

The Psoriasis Epidemiology Screening Tool (PEST) has shown a high sensitivity of 0.94, meaning it is effective at correctly identifying those with psoriatic arthritis, and a specificity of 0.78, indicating it can also correctly identify those without the condition. The Toronto Psoriatic Arthritis Screen (ToPAS) has been validated and refined to improve its ability to distinguish between those with and without psoriatic arthritis. ^{1 2 3 4 5}

Is the PsA Screening Questionnaire safe for humans?

The PsA Screening Questionnaire, including tools like ToPAS and PEST, is a set of questions used to identify signs of psoriatic arthritis. These questionnaires are non-invasive and generally safe for humans as they involve answering questions rather than medical procedures. ^{1 2 3 4 6}

Is the PsA Screening Questionnaire for Psoriatic Arthritis a promising treatment?

The PsA Screening Questionnaire is not a treatment but a tool to help identify psoriatic arthritis in people with psoriasis. It is promising because it helps doctors find the condition early, which can lead to better management and care for patients. ^{1 2 3 4 7}

Research Team

Jessica Walsh, M.D.

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

High prevalence of psoriatic arthritis in patients with severe psoriasis with suboptimal performance of screening questionnaires. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Assessment of the Toronto Psoriatic Arthritis Screen 2 as a Screening Tool for Psoriasis. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. Canada pubmed.ncbi.nlm.nih.gov

Validation of the Toronto Psoriatic Arthritis Screen Version 2 (ToPAS 2). [2022]

6. England 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Validation of the Simple Psoriatic Arthritis Screening (SiPAS) questionnaire in a Turkish psoriatic population. [2021]