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)

Novartis

Status: Completed

Conditions: Psoriasis

Treatments: Diagnostic Test: EARP group; Diagnostic Test: Routine practice group

Study type: Interventional

Funder types: Industry

Identifiers

NCT05758402

CAIN457AKR04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 368 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups

EARP group

Other group

Description:

For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.

Treatment:

Diagnostic Test: EARP group

Routine practice group

Active Comparator group

Description:

In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.

Treatment:

Diagnostic Test: Routine practice group