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)

October 30, 2023 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

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, 05030
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 05355
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 110-746
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 133 792
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of PSA
Time Frame: 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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