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)

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)

This was a randomized, open, parallel, controlled, multi-center, interventional, cross-sectional study to evaluate the detection rate of Psoriatic arthritis (PsA) in Korean moderate to severe Psoriasis (PsO) patients with or without the Early arthritis for psoriatic patients (EARP) screening.

All procedures for each patient were performed for one day. If an additional time was required depending on the circumstances of the institution and so on, the data specified in this study protocol were recommended to be collected as soon as possible. After the participants enrolled in this study, they were assessed whether they met the inclusion/exclusion criteria. In terms of the severity of PsO, it was assessed with the Psoriasis Area and Severity Index (PASI) and if the score of 10 or higher was defined as moderate to severe PsO. A total 368 eligible participants were randomized 1:1 ratio into the EARP group and the Routine practice group.

For the EARP group, the investigator asked the participants about the EARP questionnaire consisting of 10 questions. When the EARP score >= 3, the participants were suspected for having potential PsA. For Routine practice group, the investigator selected the participants suspected of PsA in consideration of the various clinical characteristics of the participants.

After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared.

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