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NCT05758402
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
Conditions: Psoriasis
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 196
Sponsor: Novartis Pharmaceuticals
Location: Korea, Republic of
Summary
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) patientsEndpoint:• Detection rate of PsASecondary 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 patientsEndpoint:Sensitivity, specificity, PPV and NPVDescription of demographic characteristics, medications and PsO related characteristics
Eligibility Criteria
Inclusion Criteria:Patient who is ≥ 19 years of age at the time of study enrollmentPatient who had an established diagnosis of PsO based upon clinical evidence and documented medical historyPatient who is moderate to severe PsO (Psoriasis Area and Severity Index (PASI) score ≥ 10)Patient who is willing and able to comply with study proceduresPatient who is able to provide the informed consent form (ICF)Exclusion Criteria:Patients who have formal pre-existing diagnosis of PsAPatients who have ever received treatment with biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)Patients who currently receive systemic glucocorticoidsPatients who currently receive opioid analgesicsPatients who has other known pre-existing dermatological or rheumatological diseasesNon-plaque psoriasisRheumatoid arthritisOsteoarthritisGoutReactive arthritisAnkylosing spondylitisAxial spondyloarthritisEnteropathic arthritisPlantar fasciitisSystemic lupus erythematosus (SLE)Female patients who are pregnantPatients who are participating in other interventional clinical trialsPatients who have already had PsA screening via screening questionnaires or imaging
Source: ClinicalTrials.gov (NCT05758402). StuddyBuddy aggregates publicly available trial information.