Clinical trial NCT05758402: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriatic arthritis
PsA
Psoriasis
PsO
Early arthritis for psoriatic patients
EARP
Classification criteria for psoriatic arthritis
CASPAR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection Rate of Psoriatic Arthritis (PsA)
timeFrame: Visit 1 (Day 1)
Secondary outcomes:
measure: Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
timeFrame: Visit 1 (Day 1)
measure: Age Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Gender Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Body Mass Index (BMI) Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Drinking and Smoking History Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Solicited Medical History by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
measure: Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
timeFrame: Visit 1 (Day 1)
Other outcomes:
Locations:
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seongnam-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Bucheon Si
country: Korea, Republic of
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Taegu
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: