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)

NCT ID: NCT05758402

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2023-06-30

Brief Summary

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.

Detailed 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EARP group

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.

Group Type: OTHER

EARP group

Intervention Type: DIAGNOSTIC_TEST

EARP group

Routine practice group

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.

Group Type: ACTIVE_COMPARATOR

Routine practice group

Intervention Type: DIAGNOSTIC_TEST

Routine practice group

Interventions

Routine practice group

Routine practice group

Intervention Type: DIAGNOSTIC_TEST

EARP group

EARP group

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Bucheon-si, , South Korea

Novartis Investigative Site

Busan, , South Korea

Novartis Investigative Site

Busan, , South Korea

Novartis Investigative Site

Gwangju, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Taegu, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2410

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

CAIN457AKR04

Identifier Type: -

Identifier Source: org_study_id