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Psoriasis (PsO)COMPOSITIONNCT07298265

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

An observational study of Psoriasis (PsO) and Psoriatic Arthritis (PsA), run by Charite University, Berlin, Germany at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis (PsO), Psoriatic Arthritis (PsA)
How many people
500 participants
Where
1 siteCanada
Study dates
22 Sep 2025to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with psoriasis presenting to a dermatologist without a diagnosis of PsA who have not been evaluated for the presence of PsA by a rheumatologist in the past. However, patients with psoriasis who have had an evaluation for the presence of PsA in the past but presenting now with new musculoskeletal symptoms will be eligible.

Who may be able to join

  • Age >= 18 years.
  • Definite diagnosis of psoriasis.
  • Written informed consent.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denis Poddubnyy, MD, PhD, MsC, Professor contact

+1416603 5753

Denis.Poddubnyy@uhn.ca

Canada1 site, 1 recruiting
  • University Health Network / University Of Toronto

    Toronto, Ontario, M5T 2S8

    Denis Poddubnyy, Professor, Denis.Poddubnyy@uhn.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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

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).

Medical subject headings
Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07298265
Study groupRoleWhat they receive
Patients with PsO presenting to dermatology, never previously assessed by a rheumatologist for PsA.Patients with PsO presenting to a dermatologist without a diagnosis of PsA who have not been evaluated for the presence of PsA by a rheumatologist in the past.However, patients with psoriasis who have had an evaluation for the presence of PsA in the past but presenting now with new musculoskeletal symptoms will be eligible.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Diagnosed with PsA by a Rheumatologist

    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

    Measured: The 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.

  2. The proportion of patients diagnosed with PsA.

    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

    Measured: Cross-sectional assessment with outcome evaluation on the same day or within 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start22 Sep 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07298265
Sponsor's protocol ID
COMPOSITION2024
Acronym
COMPOSITION
Status last verified
Dec 2025
First submitted
2 Dec 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis (PsO) and Psoriatic Arthritis (PsA), run by Charite University, Berlin, Germany at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Denis Poddubnyy, MD, PhD, MsC, Professor (+1416603 5753, Denis.Poddubnyy@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Diagnosed with PsA by a Rheumatologist (time frame: The 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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