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)
ASAP
1 other identifier
interventional
368
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2022
CompletedFirst Submitted
Initial submission to the registry
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedResults Posted
Study results publicly available
October 10, 2024
CompletedMay 16, 2025
May 1, 2025
8 months
January 9, 2023
May 24, 2024
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection Rate of Psoriatic Arthritis (PsA)
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. The detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group. The true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score \>= 3 among EARP \>= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group.
Visit 1 (Day 1)
Secondary Outcomes (13)
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Visit 1 (Day 1)
Age Characteristics by Participants With or Without PsA
Visit 1 (Day 1)
Gender Characteristics by Participants With or Without PsA
Visit 1 (Day 1)
Body Mass Index (BMI) Characteristics by Participants With or Without PsA
Visit 1 (Day 1)
Drinking and Smoking History Characteristics by Participants With or Without PsA
Visit 1 (Day 1)
- +8 more secondary outcomes
Study Arms (2)
EARP group
OTHERFor 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.
Routine practice group
ACTIVE COMPARATORIn 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-712, South Korea
Novartis Investigative Site
Seoul, Korea, 02447, South Korea
Novartis Investigative Site
Seoul, Korea, 08308, South Korea
Novartis Investigative Site
Bucheon-si, 14647, South Korea
Novartis Investigative Site
Busan, 48108, South Korea
Novartis Investigative Site
Busan, 49241, South Korea
Novartis Investigative Site
Gwangju, 501171, South Korea
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 04763, South Korea
Novartis Investigative Site
Seoul, 05030, South Korea
Novartis Investigative Site
Seoul, 07441, South Korea
Novartis Investigative Site
Seoul, 110-746, South Korea
Novartis Investigative Site
Taegu, 41944, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
March 7, 2023
Study Start
October 20, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
May 16, 2025
Results First Posted
October 10, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com