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)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Diagnostic test: EARP group; Diagnostic test: Routine practice group

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 Type: Interventional
• Enrollment (Actual): 368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon Si, Korea, Republic of, 14647
    • Novartis Investigative Site
  • Busan, Korea, Republic of, 48108
    • Novartis Investigative Site
  • Busan, Korea, Republic of, 49241
    • Novartis Investigative Site
  • Gwangju, Korea, Republic of, 501171
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 04763
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05030
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 07441
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 110-746
    • Novartis Investigative Site
  • Taegu, Korea, Republic of, 41944
    • Novartis Investigative Site
  • Gyeonggi Do
    • Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
      • Novartis Investigative Site
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
      • Novartis Investigative Site
  • Korea
    • Seoul, Korea, Korea, Republic of, 08308
      • Novartis Investigative Site
    • Seoul, Korea, Korea, Republic of, 02447
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: EARP group; EARP group
Active Comparator: 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.	Diagnostic test: Routine practice group; Routine practice group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)	Sensitivity was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false negative (FN). Specificity was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false positive (FP). Positive predictive value (PPV) was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false positive (FP). Negative predictive value (NPV) was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false negative (FN).	Visit 1 (Day 1)
Age Characteristics by Participants With or Without PsA	Age characteristics between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Gender Characteristics by Participants With or Without PsA	Gender characteristics between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Body Mass Index (BMI) Characteristics by Participants With or Without PsA	Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Drinking and Smoking History Characteristics by Participants With or Without PsA	Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA	Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA	Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA	PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 (0% of involved area) to 6 (90-100% of involved area). Within each area, the severity is estimated by three clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 (none) to 4 (maximum). The sum of all three severity parameters is then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs).	Visit 1 (Day 1)
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA	The presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) and presence or absence of musculoskeletal symptoms between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA	The Nail Psoriasis Severity Index (NAPSI) score is used to measure psoriasis of the nails. Each nail is divided into 4 equal and symmetrical quadrants to properly assess nail matrix and nail bed changes. Each nail is given a score for nail bed PsO and nail matrix PsO ranging from 0 (none) to 4 (present in 4/4 nail) depending on the presence of any of the features of nail PsO in that quadrant. A total score per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included).	Visit 1 (Day 1)
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA	66 swollen and 68 tender joints are assessed (the hips are not assessed for swelling). The joint count is scored as a sum of the tender joints and a sum of the swollen joints. SJC66: swollen joint count in 66 joints; TJC68: tender joint count in 66 joints.	Visit 1 (Day 1)
Solicited Medical History by Participants With or Without PsA	The presence or absence of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, hypertension and fatty liver)) between patients with PsA and without PsA were analyzed and compared.	Visit 1 (Day 1)
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA	The presence or absence of PsO related treatment other than medications (UV light therapy, Psoralen with ultraviolet A (PUVA), Phototherapy and Laser therapy and Naturopathy) between patients with PsA and without PsA was analyzed and compared.	Visit 1 (Day 1)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis; PsA; Psoriatic arthritis; PsO; CASPAR; EARP; Early arthritis for psoriatic patients; Classification criteria for psoriatic arthritis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: CAIN457AKR04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No