Plaque PsoriasisScreenXNCT06382051
Modifying PEST for Psoriatic Arthritis Screening
A study testing PEST Screening group in people with Plaque Psoriasis and Psoriatic Arthritis, run by Novartis Pharmaceuticals at 30 sites in Canada.
Trial summary
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis, Psoriatic Arthritis
- What is being tested?
- PEST Screening group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 30 sitesCanada
- Study dates
- 23 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.
- Adult patients at the time of informed consent signature
- Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions
- Residents of Canada
Who cannot join
- Patients who have previously screened positive for PsA through PEST.
- Patients who have been diagnosed with PsA.
- Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)
- Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
30 sites in 1 country
Canada30 sites, 30 recruiting
- Recruiting
Novartis Investigative Site
Barrie, Ontario, L4M 6L2
- Recruiting
Novartis Investigative Site
Calgary, Alberta, T2J 7E1
- Recruiting
Novartis Investigative Site
Edmonton, Alberta, T5J 3S9
- Recruiting
Novartis Investigative Site
Edmonton, Alberta, T6G 2C8
- Recruiting
Novartis Investigative Site
Fredericton, New Brunswick, E3B 1G9
- Recruiting
Novartis Investigative Site
Greater Sudbury, Ontario, P3C 1X8
- Recruiting
Novartis Investigative Site
Hamilton, Ontario, L8J 0G5
- Recruiting
Novartis Investigative Site
Hamilton, Ontario, L8N 1V6
- Recruiting
Novartis Investigative Site
Hamilton, Ontario, L8P 4B4
- Recruiting
Novartis Investigative Site
Kelowna, British Columbia, V1W 4V5
- Recruiting
Novartis Investigative Site
London, Ontario, N6A 5R9
- Recruiting
Novartis Investigative Site
London, Ontario, N6G 0W7
- Recruiting
Novartis Investigative Site
Markham, Ontario, L3R 2C7
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H1Y 3L1
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H4A 3T2
- Recruiting
Novartis Investigative Site
Ottawa, Ontario, K2A 3Z3
- Recruiting
Novartis Investigative Site
Québec, Quebec, G1V 4X7
- Recruiting
Novartis Investigative Site
Québec, Quebec, G1W 4R4
- Recruiting
Novartis Investigative Site
Richmond Hill, Ontario, L4C 9M7
- Recruiting
Novartis Investigative Site
Saskatoon, Saskatchewan, S7K 0H6
- Recruiting
Novartis Investigative Site
Saskatoon, Saskatchewan, S7K 2C1
- Recruiting
Novartis Investigative Site
Ste-Foy, Quebec, G1V 4G2
- Recruiting
Novartis Investigative Site
Stoney Creek, Ontario, L8G 1H1
- Recruiting
Novartis Investigative Site
Surrey, British Columbia, V3R 6A7
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M4A 2S8
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M5S 1B6
- Recruiting
Novartis Investigative Site
Verdun, Quebec, H4G 3E7
- Recruiting
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
- Recruiting
Novartis Investigative Site
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada ("ScreenX")
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
Read the detailed description
Patients will be enrolled in the study for up to 120 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status.
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis
- Being tested
- PEST Screening group
- Keywords
- Psoriasis, Psoriatic Arthritis, PsA, Plaque Psoriasis, PsO, Implementation Science, Psoriasis Epidemiology Screening Tool
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEST Screening groupDiagnostic test
PEST Screening group
| Study group | Role | What they receive |
|---|---|---|
| PEST Screening group | Other | When visiting their dermatologists, all eligible patients with moderate-to-severe plaque psoriasis (PsO) eligible for treatment with biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) will be screened for psoriatic arthritis (PsA) using PEST+pictures+2, a variation of the PEST screening tool.
The PEST+pictures+2 is made up of 3 components:
1. Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions
2. PEST+2 refers to the PEST modified with two additional questions (Do you have morning stiffness that lasts for more than one (1) hour? Do you wake up at night because of low back or buttock pain?), AND
3. PEST+pictures which provides an opportunity for patients to modify their answers to PEST questions 1, 3, and 5 by presenting them with pictures of swollen joints, fingernail pitting, and swollen fingers and toes. Receives: Diagnostic Test: PEST Screening group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
To assess the impact of adding two questions (morning stiffness and low back or buttock pain) to the validated PEST for the potential diagnosis of PsA in moderate-to-severe plaque PsO patients who are candidates for biologic disease-modifying antirheumatic drugs (bDMARDs) The primary clinical question of interest is: Can the addition of two questions to PEST pertaining to presence of morning stiffness and low back or buttock pain (i.e., PEST+2) allow for improved screening and diagnosis of PsA in patients with moderate-to-severe plaque PsO?
Measured: Up to approximately 1 year
Secondary outcomes (8)
Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
To estimate the proportion of patients with a confirmed or suspected PsA diagnosis referred by dermatologists using PEST+2 only
Measured: Up to approximately 1 year
Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Proportion of patients with a new PsA diagnosis or suspicion of PsA, confirmed by the rheumatologist who scored:
- Negative on PEST and positive on PEST+pictures
- Negative on PEST+2 and positive on PEST+pictures+2 will be evaluated to assess the impact of adding pictures as reference to guide patients answering the screening questions (question 1, 3, and 5)
Measured: Up to approximately 1 year
Proportion of patients with a false positive score between each group
Proportion of patients with false positive score between each group will be evaluated:
- PEST+2 vs. PEST+pictures+2
- PEST+pictures vs. PEST
- PEST+pictures+2 vs. PEST
Measured: Up to approximately 1 year
Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
Description of the baseline characteristics (i.e., patient age, biological sex, years since plaque PsO diagnosis, medical history, disease characteristics, concomitant treatments, height, weight, etc.) of the positive screening score and negative screening score patients for both PEST and PEST+2 tests will be evaluated to determine patient's baseline characteristics.
Measured: Up to approximately 1 year
Patient acceptability/user experience of the PEST+2 questionnaire
Summary scores of the patient acceptability questionnaire of PsA screening questionnaires and a categorical presentation of question-by-question responses at Visit 1
Measured: Up to approximately 1 year
Administration of dermatologist quantitative surveys
Administration of dermatologist quantitative surveys, as well as open-ended qualitative questions to assess the acceptability and feasibility of the PEST+pictures+2 from the perspective of dermatologists
Measured: Up to approximately 1 year
Qualitative interview with selected dermatologists
Brief 1:1 qualitative interview with selected dermatologists (maximum 12) to assess their knowledge, beliefs, and attitudes towards PsA screening (e.g., motivation to screen)
Measured: Up to approximately 1 year
Intervention Appropriateness Measure (IAM)
To assess the appropriateness of the PEST+2 from the perspective of rheumatologists
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start23 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382051
- Sponsor's protocol ID
- CAIN457ACA06
- Acronym
- ScreenX
- Status last verified
- Sep 2026
- First submitted
- 19 Apr 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada ("ScreenX")
- ClinicalTrials.gov ID
- NCT06382051
- Acronym / sponsor ID
- ScreenX / CAIN457ACA06
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis
- Keywords
- Psoriasis, Psoriatic Arthritis, PsA, Plaque Psoriasis, PsO, Implementation Science, Psoriasis Epidemiology Screening Tool
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 2024 (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.
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
Detailed description
Patients will be enrolled in the study for up to 120 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEST Screening group | Other | Diagnostic Test: PEST Screening groupWhen visiting their dermatologists, all eligible patients with moderate-to-severe plaque psoriasis (PsO) eligible for treatment with biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) will be screened for psoriatic arthritis (PsA) using PEST+pictures+2, a variation of the PEST screening tool. The PEST+pictures+2 is made up of 3 components: 1. Psoriasis Epidemiology Screening Tool (PEST) consisting of 5 simple questions 2. PEST+2 refers to the PEST modified with two additional questions (Do you have morning stiffness that lasts for more than one (1) hour? Do you wake up at night because of low back or buttock pain?), AND 3. PEST+pictures which provides an opportunity for patients to modify their answers to PEST questions 1, 3, and 5 by presenting them with pictures of swollen joints, fingernail pitting, and swollen fingers and toes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.
- Adult patients at the time of informed consent signature
- Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions
- Residents of Canada
Key exclusion criteria (4 listed)
- Patients who have previously screened positive for PsA through PEST.
- Patients who have been diagnosed with PsA.
- Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)
- Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEST Screening groupPEST Screening group | Diagnostic test | PEST Screening group |
Primary outcome
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs
Time frame: Up to approximately 1 year
To assess the impact of adding two questions (morning stiffness and low back or buttock pain) to the validated PEST for the potential diagnosis of PsA in moderate-to-severe plaque PsO patients who are candidates for biologic disease-modifying antirheumatic drugs (bDMARDs) The primary clinical question of interest is: Can the addition of two questions to PEST pertaining to presence of morning stiffness and low back or buttock pain (i.e., PEST+2) allow for improved screening and diagnosis of PsA in patients with moderate-to-severe plaque PsO?
8 secondary outcomes
Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Time frame: Up to approximately 1 year
Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist
Time frame: Up to approximately 1 year
Proportion of patients with a false positive score between each group
Time frame: Up to approximately 1 year
Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests
Time frame: Up to approximately 1 year
Patient acceptability/user experience of the PEST+2 questionnaire
Time frame: Up to approximately 1 year
Administration of dermatologist quantitative surveys
Time frame: Up to approximately 1 year
Qualitative interview with selected dermatologists
Time frame: Up to approximately 1 year
Intervention Appropriateness Measure (IAM)
Time frame: Up to approximately 1 year
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 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEST Screening group in people with Plaque Psoriasis and Psoriatic Arthritis, run by Novartis Pharmaceuticals at 30 sites 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 4 inclusion and 4 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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 Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs (time frame: Up to approximately 1 year). 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 28 Sep 2026.