A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)

Study Overview
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Brief Summary
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Primary objective To compare the detection rate of PsA with EARP screening versus detection rate of PsA without EARP screening in routine clinical practice in dermatological clinics amongst moderate to severe Korean Psoriasis (PsO) patients Endpoint: • Detection rate of PsA Secondary Objective To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) between EARP questionnaire (EARP group) and the investigator's judgement (Routine practice group) To describe the patient characteristics and disease severity between PsA and non-PsA patients Endpoint: Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics

Official Title
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A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)

Conditions
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Psoriasis

Intervention / Treatment
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* Diagnostic Test: Routine practice groups
* Diagnostic Test: EARP group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is ≥ 19 years of age at the time of study enrollment Patient who had an established diagnosis of PsO based upon clinical evidence and documented medical history Patient who is moderate to severe PsO (Psoriasis Area and Severity Index (PASI) score ≥ 10) Patient who is willing and able to comply with study procedures Patient who is able to provide the informed consent form (ICF) Exclusion Criteria: Patients who have formal pre-existing diagnosis of PsA Patients who have ever received treatment with biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) Patients who currently receive systemic glucocorticoids Patients who currently receive opioid analgesics Patients who has other known pre-existing dermatological or rheumatological diseases Non-plaque psoriasis Rheumatoid arthritis Osteoarthritis Gout Reactive arthritis Ankylosing spondylitis Axial spondyloarthritis Enteropathic arthritis Plantar fasciitis Systemic lupus erythematosus (SLE) Female patients who are pregnant Patients who are participating in other interventional clinical trials Patients who have already had PsA screening via screening questionnaires or imaging

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) between EARP questionnaire (EARP group) and the investigator's judgement (Routine practice group) To describe the patient characteristics and disease severity between PsA and non-PsA patients Endpoint: Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EARP group<br>EARP group | Diagnostic Test: EARP group<br>* EARP group<br>|
| Active Comparator: Routine practice groups<br>Routine practice groups | Diagnostic Test: Routine practice groups<br>* Routine practice groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of PSA | To compare the detection rate of PsA with EARP screening versus detection rate of PsA without EARP screening in routine clinical practice in dermatological clinics amongst moderate to severe Korean PsO patients. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics | To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) between EARP questionnaire (EARP group) and the investigator's judgement (Routine practice group) To describe the patient characteristics and disease severity between PsA and non-PsA patients | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EARP, Psoriasis, PsO, psoriatic arthritis, PsA