PsoriasisASAPNCT05758402
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)
A study testing Routine practice group and EARP group in people with Psoriasis, run by Novartis Pharmaceuticals at 15 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Routine practice group and EARP group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 20 Oct 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Novartis Investigative Site
Bucheon-si, 14647
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Busan, 48108
Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Gwangju, 501171
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-712
Novartis Investigative Site
Seoul, Korea, 02447
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 04763
Novartis Investigative Site
Seoul, 05030
Novartis Investigative Site
Seoul, 07441
Novartis Investigative Site
Seoul, 110-746
Novartis Investigative Site
Taegu, 41944
About this study
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.
Read the detailed description
All procedures for each patient were performed for one day. If an additional time was required depending on the circumstances of the institution and so on, the data specified in this study protocol were recommended to be collected as soon as possible. After the participants enrolled in this study, they were assessed whether they met the inclusion/exclusion criteria. In terms of the severity of PsO, it was assessed with the Psoriasis Area and Severity Index (PASI) and if the score of 10 or higher was defined as moderate to severe PsO. A total 368 eligible participants were randomized 1:1 ratio into the EARP group and the Routine practice group.
For the EARP group, the investigator asked the participants about the EARP questionnaire consisting of 10 questions. When the EARP score >= 3, the participants were suspected for having potential PsA. For Routine practice group, the investigator selected the participants suspected of PsA in consideration of the various clinical characteristics of the participants.
After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared.
- Conditions
- Psoriasis
- Being tested
- Routine practice group, EARP group
- Keywords
- Psoriatic arthritis, PsA, Psoriasis, PsO, Early arthritis for psoriatic patients, EARP, Classification criteria for psoriatic arthritis, CASPAR
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine practice groupDiagnostic test
Routine practice group
EARP groupDiagnostic test
EARP group
| Study group | Role | What they receive |
|---|---|---|
| EARP group | Other | For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR. Receives: Diagnostic Test: EARP group |
| Routine practice group | Active comparator | In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR. Receives: Diagnostic Test: Routine practice group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rate of Psoriatic Arthritis (PsA)
After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared.
The detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group.
The true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score >= 3 among EARP >= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group.
Measured: Visit 1 (Day 1)
Secondary outcomes (13)
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Sensitivity was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false negative (FN).
Specificity was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false positive (FP).
Positive predictive value (PPV) was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false positive (FP).
Negative predictive value (NPV) was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false negative (FN).
Measured: Visit 1 (Day 1)
Age Characteristics by Participants With or Without PsA
Age characteristics between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Gender Characteristics by Participants With or Without PsA
Gender characteristics between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Body Mass Index (BMI) Characteristics by Participants With or Without PsA
Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Drinking and Smoking History Characteristics by Participants With or Without PsA
Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA
Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA
PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 (0% of involved area) to 6 (90-100% of involved area). Within each area, the severity is estimated by three clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 (none) to 4 (maximum). The sum of all three severity parameters is then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs).
Measured: Visit 1 (Day 1)
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
The presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) and presence or absence of musculoskeletal symptoms between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
The Nail Psoriasis Severity Index (NAPSI) score is used to measure psoriasis of the nails. Each nail is divided into 4 equal and symmetrical quadrants to properly assess nail matrix and nail bed changes. Each nail is given a score for nail bed PsO and nail matrix PsO ranging from 0 (none) to 4 (present in 4/4 nail) depending on the presence of any of the features of nail PsO in that quadrant. A total score per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included).
Measured: Visit 1 (Day 1)
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
66 swollen and 68 tender joints are assessed (the hips are not assessed for swelling). The joint count is scored as a sum of the tender joints and a sum of the swollen joints. SJC66: swollen joint count in 66 joints; TJC68: tender joint count in 66 joints.
Measured: Visit 1 (Day 1)
Solicited Medical History by Participants With or Without PsA
The presence or absence of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, hypertension and fatty liver)) between patients with PsA and without PsA were analyzed and compared.
Measured: Visit 1 (Day 1)
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
The presence or absence of PsO related treatment other than medications (UV light therapy, Psoralen with ultraviolet A (PUVA), Phototherapy and Laser therapy and Naturopathy) between patients with PsA and without PsA was analyzed and compared.
Measured: Visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start20 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758402
- Sponsor's protocol ID
- CAIN457AKR04
- Acronym
- ASAP
- Status last verified
- May 2025
- First submitted
- 9 Jan 2023
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05758402
- Acronym / sponsor ID
- ASAP / CAIN457AKR04
- Conditions
- Psoriasis
- Keywords
- Psoriatic arthritis, PsA, Psoriasis, PsO, Early arthritis for psoriatic patients, EARP, Classification criteria for psoriatic arthritis, CASPAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All procedures for each patient were performed for one day. If an additional time was required depending on the circumstances of the institution and so on, the data specified in this study protocol were recommended to be collected as soon as possible. After the participants enrolled in this study, they were assessed whether they met the inclusion/exclusion criteria. In terms of the severity of PsO, it was assessed with the Psoriasis Area and Severity Index (PASI) and if the score of 10 or higher was defined as moderate to severe PsO. A total 368 eligible participants were randomized 1:1 ratio into the EARP group and the Routine practice group.
For the EARP group, the investigator asked the participants about the EARP questionnaire consisting of 10 questions. When the EARP score >= 3, the participants were suspected for having potential PsA. For Routine practice group, the investigator selected the participants suspected of PsA in consideration of the various clinical characteristics of the participants.
After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EARP group | Other | Diagnostic Test: EARP groupFor the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR. |
| Routine practice group | Active comparator | Diagnostic Test: Routine practice groupIn the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine practice groupRoutine practice group | Diagnostic test | Routine practice group |
| EARP groupEARP group | Diagnostic test | EARP group |
Primary outcome
Detection Rate of Psoriatic Arthritis (PsA)
Time frame: Visit 1 (Day 1)
After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared. The detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group. The true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score >= 3 among EARP >= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group.
13 secondary outcomes
Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)
Time frame: Visit 1 (Day 1)
Age Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Gender Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Body Mass Index (BMI) Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Drinking and Smoking History Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Solicited Medical History by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA
Time frame: Visit 1 (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine practice group and EARP group in people with Psoriasis, run by Novartis Pharmaceuticals at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection Rate of Psoriatic Arthritis (PsA) (time frame: Visit 1 (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.