A Randomized 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
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)
ClinicalTrials.gov Identifier: NCT05758402
Novartis Reference Number: CAIN457AKR04
Last Update: Mar 07, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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
Interventions
Eligibility Criteria
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]