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A Randomized 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05758402
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Psoriasis Diagnostic Test: Routine practice groups Diagnostic Test: EARP group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : April 21, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
EARP group
EARP group
 Diagnostic Test: EARP group
EARP group
Active Comparator: Routine practice groups
Routine practice groups
 Diagnostic Test: Routine practice groups
Routine practice groups


Outcome Measures
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Primary Outcome Measures :
  1. Detection rate of PSA [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures :
  1. Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics [ Time Frame: 24 hours ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05758402


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Korea, Republic of
Novartis Investigative Site Recruiting
Gwangju, Korea, Republic of, 501171
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05758402    
Other Study ID Numbers: CAIN457AKR04
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PsA
EARP
Psoriasis
PsO
psoriatic arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
 Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases