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 Clinical Trial

— ASAP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05758402
• Other study ID #: CAIN457AKR04
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective To compare the detection rate of PsA with EARP screening versus detection rate of PsA without EARP screening in routine clinical practice in dermatological clinics amongst moderate to severe Korean Psoriasis (PsO) patients

Endpoint:

• Detection rate of PsA

Secondary Objective To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) between EARP questionnaire (EARP group) and the investigator's judgement (Routine practice group) To describe the patient characteristics and disease severity between PsA and non-PsA patients

Endpoint:

• Sensitivity, specificity, PPV and NPV

• Description of demographic characteristics, medications and PsO related characteristics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patient who is = 19 years of age at the time of study enrollment

2. Patient who had an established diagnosis of PsO based upon clinical evidence and documented medical history

3. Patient who is moderate to severe PsO (Psoriasis Area and Severity Index (PASI) score = 10)

4. Patient who is willing and able to comply with study procedures

5. Patient who is able to provide the informed consent form (ICF)

Exclusion Criteria:

1. Patients who have formal pre-existing diagnosis of PsA

2. Patients who have ever received treatment with biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

3. Patients who currently receive systemic glucocorticoids

4. Patients who currently receive opioid analgesics

5. 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)

6. Female patients who are pregnant

7. Patients who are participating in other interventional clinical trials

8. Patients who have already had PsA screening via screening questionnaires or imaging

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis

Intervention

Diagnostic Test:
• Routine practice groups
Routine practice groups
• EARP group
EARP group

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Bucheon si
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Taegu

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of PSA	To compare the detection rate of PsA with EARP screening versus detection rate of PsA without EARP screening in routine clinical practice in dermatological clinics amongst moderate to severe Korean PsO patients.	4 weeks
Secondary	Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics	To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) between EARP questionnaire (EARP group) and the investigator's judgement (Routine practice group) To describe the patient characteristics and disease severity between PsA and non-PsA patients	4 weeks