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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)

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Routine practice groups
EARP group
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriasis focused on measuring PsA, EARP, Psoriasis, PsO, psoriatic arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

EARP group

Routine practice groups

Arm Description

EARP group

Routine practice groups

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2023
Last Updated
September 28, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05758402
Brief 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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
PsA, EARP, Psoriasis, PsO, psoriatic arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EARP group
Arm Type
Other
Arm Description
EARP group
Arm Title
Routine practice groups
Arm Type
Active Comparator
Arm Description
Routine practice groups
Intervention Type
Diagnostic Test
Intervention Name(s)
Routine practice groups
Intervention Description
Routine practice groups
Intervention Type
Diagnostic Test
Intervention Name(s)
EARP group
Intervention Description
EARP group
Primary Outcome Measure Information:
Title
Detection rate of PSA
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sensitivity, specificity, PPV and NPV Description of demographic characteristics, medications and PsO related characteristics
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Bucheon si
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
501171
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
133 792
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Taegu
ZIP/Postal Code
41944
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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)

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