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Physician- vs Questionnaire-Based Screening for Psoriatic Arthritis in Psoriasis

Comparison of a Physician-Based Versus Questionnaire-Based Approach to Identify Patients With a High Probability of Psoriatic Arthritis Among Patients With Psoriasis: A Prospective Multicenter Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07298265
Acronym
COMPOSITION
Enrollment
500
Registered
2025-12-23
Start date
2025-09-22
Completion date
2026-10-31
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis (PsO), Psoriatic Arthritis (PsA)

Brief summary

Early diagnosis of psoriatic arthritis (PsA) requires close collaboration between dermatologists (as the skin manifestations of psoriatic disease in most cases precede the musculoskeletal manifestations) and rheumatologists (who are usually responsible for the final diagnosis of PsA and treatment of the musculoskeletal manifestations). Previous epidemiological studies suggest that there may still be a significant proportion of undiagnosed PsA patients among those with psoriasis seen by a dermatologist. At the same time, a diagnostic delay of more than 6 months contributes to poor radiological and functional outcomes in PsA patients. Several screening tools / questionnaires (including the Psoriatic Arthritis Screening Evaluation - PASE, the Toronto Psoriatic Arthritis Screen - ToPAS and its further development - TOPAS 2, the Psoriasis Epidemiology Screening Tool - PEST, and the Early Psoriatic Arthritis Screening Questionnaire - EARP) have been developed and validated in the past decades - all relying mostly on symptoms reported by a patient with psoriasis without an evaluation / confirmation of the presence of musculoskeletal symptoms by a dermatologist. The CONTEST study, which compared three screening tools (PASE, ToPAS and PEST) in a secondary care setting, determined that they all had a good probability of detecting PsA (sensitivity of approximately 80%) but had poor specificity (approximately 35%). Further analysis of the results of the above study has identified the most discriminative questions from each of the three questionnaires, including questions about the back and neck, and these items have been combined to create a new single 8-item screening questionnaire (CONTEST). However, a subsequent study demonstrated a similar performance for the CONTEST and the PEST tools. This poor specificity means that screening questionnaires are often not used in practice and raises a risk of overwhelming rheumatology referrals. In a recent survey of GRAPPA members, most of the participants (consisting of dermatologists, rheumatologists, and patient research partners), suggested that a basic evaluation of MSK symptoms by a dermatologist in addition to the patient-reported symptoms (questionnaire) should be part of the screening / referral process. We hypothesize, therefore, that adding a MSK evaluation by dermatologist in the screening process will be able to improve the outcome of the screening and referral process in relation to the PsA detection. In this study, we plan to evaluate the performance of a physician (dermatologist)-based screening and referral strategy as compared to the strategy based on a questionnaire completed by a patient for the detection of patients with a high probability of a diagnosis of PsA among patients with psoriasis. The primary endpoint will be the proportion of patients diagnosed with PsA among patients with psoriasis referred to a rheumatologist. This will be evaluated in the following groups: 1) PEST-positive and dermatologist-negative patients 2) PEST-positive and dermatologist-positive patients 3) PEST-negative and dermatologist-positive patients 4) PEST-negative and dermatologist-negative patients The primary comparison of the proportions of patients diagnosed with PsA (Fisher's exact test) will be done between the dermatologist-negative vs. positive patients among PEST-positive ones (group 1 vs. group 2).

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \>= 18 years. 2. Definite diagnosis of psoriasis. 3. Written informed consent.

Exclusion criteria

1. Unable or unwilling to give informed consent or to comply with the protocol. 2. Previously assessed by a rheumatologist for the presence of PsA, unless new musculoskeletal symptoms have emerged subsequent to the prior evaluation.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients Diagnosed with PsA by a RheumatologistThe study is cross-sectional. Ideally, patients should be seen by both dermatologists and rheumatologists on the same day. However, a window of up to 4 weeks between the dermatology and rheumatology examinations is acceptable.The primary outcome will be the proportion of patients diagnosed with PsA by a rheumatologist. This outcome will be evaluated in the following groups: 1. PEST-positive and dermatologist-negative patients 2. PEST-positive and dermatologist-positive patients 3. PEST-negative and dermatologist-positive patients 4. PEST-negative and dermatologist-negative patients
The proportion of patients diagnosed with PsA.Cross-sectional assessment with outcome evaluation on the same day or within 28 daysThe primary outcome will be the proportion of patients diagnosed with PsA by a rheumatologist. This outcome will be evaluated in the following groups: 1. PEST-positive and dermatologist-negative patients 2. PEST-positive and dermatologist-positive patients 3. PEST-negative and dermatologist-positive patients 4. PEST-negative and dermatologist-negative patients

Countries

Canada

Contacts

Primary ContactDenis Poddubnyy, MD, PhD, MsC, Professor
Denis.Poddubnyy@uhn.ca+1416603 5753

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026