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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 368
- Locations
- 15
- Primary Endpoint
- Detection Rate of Psoriatic Arthritis (PsA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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.
Intervention: Routine practice group (Diagnostic Test)
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.
Intervention: EARP group (Diagnostic Test)
Outcomes
Primary Outcomes
Detection Rate of Psoriatic Arthritis (PsA)
Time Frame: Visit 1 (Day 1)
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.
Secondary Outcomes
- 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))
- Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA(Visit 1 (Day 1))
- Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA(Visit 1 (Day 1))
- Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA(Visit 1 (Day 1))
- The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA(Visit 1 (Day 1))
- Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA(Visit 1 (Day 1))
- SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA(Visit 1 (Day 1))
- Solicited Medical History by Participants With or Without PsA(Visit 1 (Day 1))
- Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA(Visit 1 (Day 1))