N/A N=368 Randomized Diagnostic

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)

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT05758402 ↗

Enrolled (actual)

368

Serious AEs

—

Results posted

Oct 2024

Primary outcome: Primary: Detection Rate of Psoriatic Arthritis (PsA) — 8; 6 Participants — p=0.544

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Routine practice group (Diagnostic_test); EARP group (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Detection Rate of Psoriatic Arthritis (PsA)	8; 6	0.544
SECONDARY Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)	8; 6; 129; 157; 8; 6	0.256
SECONDARY Age Characteristics by Participants With or Without PsA	48.14; 44.02	0.101
SECONDARY Gender Characteristics by Participants With or Without PsA	20; 249; 8; 91	0.836
SECONDARY Body Mass Index (BMI) Characteristics by Participants With or Without PsA	25.02; 25.76	0.520
SECONDARY Drinking and Smoking History Characteristics by Participants With or Without PsA	20; 186; 4; 89; 4; 65	0.216
SECONDARY Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA	132.08; 118.12	0.831
SECONDARY Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA	6; 48; 22; 292; 1; 3	0.274
SECONDARY Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA	13.76; 13.62	0.622
SECONDARY The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA	27; 211; 1; 129; 16; 70	<0.001 sig
SECONDARY Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA	10.43; 4.71; 9.18; 4.91; 9.29; 4.35	<0.001 sig
SECONDARY SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA	5.36; 0.51; 6.00; 0.83; 11.36; 1.34	<0.001 sig
SECONDARY Solicited Medical History by Participants With or Without PsA	0; 0; 3; 8; 25; 332	0.043 sig
SECONDARY Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA	2; 20; 1; 11; 0; 7	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05758402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.