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)

Not Applicable

Completed

Conditions: Psoriasis

Interventions: Diagnostic Test: EARP group
Diagnostic Test: Routine practice group

Registration Number: NCT05758402

Lead Sponsor: Novartis Pharmaceuticals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 368

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EARP group	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.
Routine practice 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.

Primary Outcome Measures

Name	Time	Method
Detection Rate of Psoriatic Arthritis (PsA)	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 Outcome Measures

Name	Time	Method
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)	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).
Age Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	Age characteristics between patients with PsA and without PsA were analyzed and compared.
Gender Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	Gender characteristics between patients with PsA and without PsA were analyzed and compared.
Body Mass Index (BMI) Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.
Drinking and Smoking History Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.
Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.
Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	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).
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	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.
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	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).
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA	Visit 1 (Day 1)	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.
Solicited Medical History by Participants With or Without PsA	Visit 1 (Day 1)	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.
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA	Visit 1 (Day 1)	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.