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.
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.
Canada1 site, 1 recruiting
- Recruiting
University Health Network / University Of Toronto
Toronto, Ontario, M5T 2S8
Denis Poddubnyy, Professor, Denis.Poddubnyy@uhn.ca
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).
- Conditions
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- 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 group | Role | What 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.
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:
- PEST-positive and dermatologist-negative patients
- PEST-positive and dermatologist-positive patients
- PEST-negative and dermatologist-positive patients
- 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.
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:
- PEST-positive and dermatologist-negative patients
- PEST-positive and dermatologist-positive patients
- PEST-negative and dermatologist-positive patients
- 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.
- First posted23 Dec 2025
- Study start22 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Poddubnyy, Charite University, Berlin, Germany
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07298265
- Acronym / sponsor ID
- COMPOSITION / COMPOSITION2024
- Conditions
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Age >= 18 years.
- Definite diagnosis of psoriasis.
- Written informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
Time frame: Cross-sectional assessment with outcome evaluation on the same day or within 28 days
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.