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)
Phase: NA
Conditions: Psoriasis
Sponsor: Novartis Pharmaceuticals

Novartis Research and Development 
Investigational Drug Code/Generic Name – Not applicable 
Clinical Trial Protocol CAIN457AKR04 / NCT05758402 
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)
Document type: 
Synopsis/Clinical Trial Protocol 
EUDRACT number: 
Not applicable (No drug involved) 
Version number: 
01 (Original Protocol) 
Clinical Trial Phase: 
Not applicable (No drug involved) 
Release date: 
29Mar2022 
Property of Novartis 
Confidential 
May not be used, divulged, published, or otherwise disclosed 
without the consent of Novartis 
Clinical Trial Protocol Template Version 4.0 dated 15-Feb-2021 

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Table of contents 
 
Table of contents ................................................................................................................. 2 
List of tables ........................................................................................................................ 4 
List of figures ...................................................................................................................... 4 
List of abbreviations ............................................................................................................ 5 
Glossary of terms ................................................................................................................. 6 
Protocol summary ................................................................................................................ 7 
1 
Introduction ....................................................................................................................... 10 
1.1 
Background ............................................................................................................ 10 
1.2 
Purpose .................................................................................................................. 11 
2 
Objectives and endpoints  .................................................................................................. 11 
3 
Study design ...................................................................................................................... 12 
4 
Rationale ............................................................................................................................ 13 
4.1 
Rationale for study design ..................................................................................... 13 
4.2 
Rationale for Intervention ...................................................................................... 14 
4.3 
Rationale for choice of control group .................................................................... 14 
4.4 
Purpose and timing of interim analyses/design adaptations .................................. 15 
4.5 
Risks and benefits .................................................................................................. 15 
4.6 
Rationale for Public Health Emergency mitigation procedures ............................ 15 
5 
Study Population ............................................................................................................... 15 
5.1 
Inclusion criteria .................................................................................................... 15 
5.2 
Exclusion criteria ................................................................................................... 15 
6 
Study Intervention ............................................................................................................. 16 
6.1 
Study Intervention ................................................................................................. 16 
6.1.1 
EARP group .......................................................................................... 16 
6.1.2 
Routine practice group .......................................................................... 16 
6.2 
Participant numbering, randomization .................................................................. 16 
6.2.1 
Participant numbering ........................................................................... 16 
6.2.2 
Randomization ...................................................................................... 16 
6.3 
Blinding ................................................................................................................. 17 
7 
Informed consent procedures ............................................................................................ 17 
8 
Visit schedule and assessments ......................................................................................... 17 
8.1 
Screening ............................................................................................................... 20 
8.1.1 
Information to be collected on screening failures ................................. 20 
8.2 
Participant demographics/other baseline characteristics ....................................... 20 

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8.2.1 
Demographic characteristics ................................................................. 20 
8.2.2 
Medical history and medication ............................................................ 20 
8.3 
EARP ..................................................................................................................... 21 
8.4 
Physical examinations ........................................................................................... 22 
8.4.1 
NAPSI ................................................................................................... 22 
8.4.2 
SJC66/TJC68 ........................................................................................ 23 
8.5 
Efficacy .................................................................................................................. 24 
8.5.1 
Primary endpoint ................................................................................... 24 
8.5.2 
Secondary endpoint ............................................................................... 25 
8.6 
Safety ..................................................................................................................... 26 
8.7 
Additional assessments .......................................................................................... 26 
9 
Discontinuation and completion ........................................................................................ 26 
9.1 
Discontinuation from study treatment and from study .......................................... 26 
9.2 
Withdrawal of informed consent/Opposition to use data/biological samples ....... 27 
9.3 
Study completion and post-study treatment .......................................................... 27 
9.4 
Early study termination by the sponsor ................................................................. 27 
10 Safety monitoring, reporting and committees ................................................................... 27 
10.1 
Definition of adverse events and reporting requirements ...................................... 27 
10.2 
Additional Safety Monitoring ................................................................................ 27 
10.3 
Committees ............................................................................................................ 28 
11 Data Collection and Database management ...................................................................... 28 
11.1 
Data collection ....................................................................................................... 28 
11.2 
Database management and quality control ............................................................ 28 
11.3 
Site monitoring ...................................................................................................... 28 
12 Data analysis and statistical methods ................................................................................ 29 
12.1 
Analysis sets .......................................................................................................... 29 
12.2 
Participant demographics and other baseline characteristics................................. 29 
12.3 
Treatments ............................................................................................................. 30 
12.4 
Analysis supporting primary objectives ................................................................ 30 
12.4.1 
Definition of primary endpoint(s) ......................................................... 30 
12.4.2 
Statistical model, hypothesis, and method of analysis .......................... 30 
12.4.3 
Sensitivity analyses ............................................................................... 31 
12.4.4 
Supplementary analysis ......................................................................... 31 
12.5 
Analysis supporting secondary objectives ............................................................. 31 
12.5.1 
Sensitivity, specificity, PPV and NPV .................................................. 31 
12.5.2 
Demographic characteristics and PsO related characteristics ............... 31 

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12.6 
Interim analyses ..................................................................................................... 32 
12.7 
Sample size calculation ......................................................................................... 32 
13 Ethical considerations and administrative procedures ...................................................... 33 
13.1 
Regulatory and ethical compliance ........................................................................ 33 
13.2 
Responsibilities of the investigator and IRB ......................................................... 33 
13.3 
Publication of study protocol and results .............................................................. 33 
13.4 
Quality Control and Quality Assurance ................................................................. 33 
13.5 
Participant Engagement ......................................................................................... 33 
14 Protocol adherence ............................................................................................................ 34 
14.1 
Protocol amendments ............................................................................................ 34 
15 References ......................................................................................................................... 35 
Appendix 1. EARP questionnaire ............................................................................................. 38 
 
List of tables 
Table 2–1 
Objectives and related endpoints .......................................................... 11 
Table 2–2 
Evaluation outcomes  ............................................................................ 12 
Table 8–1 
Assessment schedule ............................................................................. 18 
Table 8–2 
CASPAR score ...................................................................................... 24 
 
List of figures 
Figure 3-1 
Study design .......................................................................................... 13 
Figure 8-1 
NAPSI score .......................................................................................... 23 
Figure 8-2 
SJC66/TJC68 score ............................................................................... 24 
 

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List of abbreviations 
 
BMI 
Body mass index 
CASPAR 
Classification criteria for psoriatic arthritis 
CI 
Confidence interval 
CRO 
Contract research organization 
CTT 
Clinical trial team 
DMARD 
Disease-modifying anti-rheumatic drug 
EARP 
Early arthritis for psoriatic patients 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FAS 
Full analysis set 
GCP 
Good clinical practice 
GRAPPA 
Group for research and assessment of psoriasis and psoriatic arthritis 
ICF 
Informed consent form 
ICH 
International council for harmonization of technical requirements for 
pharmaceuticals for human use 
IRB 
Institutional review board 
IWRS 
Interactive web response system 
MedDRA 
Medical dictionary for regulatory activities  
NAPSI 
Nail psoriasis severity index 
NPV 
Negative predictive value 
PASI 
Psoriasis area and severity index 
PPS 
Per protocol set 
PPV 
Positive predictive value 
PsA 
Psoriatic arthritis 
PsO 
Psoriasis 
QMS  
Quality management system 
SJC 
Swollen joint count 
SLE 
Systemic lupus erythematosus 
SOP 
Standard operating procedure 
TJC 
Tender joint count 
WHO 
World health organization  

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Glossary of terms 
 
Assessment 
A procedure used to generate data required by the study 
Clinical Trial Team 
A group of people responsible for the planning, execution and 
reporting of all clinical trial activities. Examples of team members 
include the Study Lead, Medical Monitor, Trial Statistician etc. 
Coded Data 
Personal Data which has been de-identified by the investigative 
center team by replacing personal identifiers with a code. 
Electronic Data Capture 
(EDC) 
Electronic data capture (EDC) is the electronic acquisition of 
clinical study data using data collection systems, such as Web-
based applications, interactive voice response systems and 
clinical laboratory interfaces. EDC includes the use of Electronic 
Case Report Forms (eCRFs) which are used to capture data 
transcribed from source data/documents used at the point of care 
Enrollment 
Point/time of participant entry into the study at which informed 
consent must be obtained. The action of enrolling one or more 
participants 
Participant 
A trial participant (can be a healthy volunteer or a patient). 
"Participant" terminology is used in the protocol whereas term 
"Subject" is used in data collection 
Participant number 
A unique number assigned to each participant upon signing the 
informed consent. This number is the definitive, unique identifier 
for the participant and should be used to identify the participant 
throughout the study for all data collected, sample labels, etc. 
Personal data 
Participant information collected by the Investigator that is coded 
and transferred to Novartis for the purpose of the clinical trial. 
This data includes participant identifier information, study 
information and biological samples. 
Randomization 
The process of assigning trial participants to investigational drug 
or control/comparator drug using an element of chance to 
determine the assignments in order to reduce bias. 
Randomization number 
A unique identifier assigned to each randomized participant 
Screen Failure 
A participant who did not meet one or more criteria that were 
required for participation in the study 
Source Data/Document 
Source data refers to the initial record, document, or primary 
location from where data comes. The data source can be a 
database, a dataset, a spreadsheet or even hard-coded data, such 
as paper or eSource 
Variable (or endpoint) 
The variable (or endpoint) to be obtained for each participant that 
is required to address the clinical question. The specification of 
the variable might include whether the participant experiences an 
intercurrent event. 

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Protocol summary 
 
Protocol number 
CAIN457AKR04 
Full 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) 
Brief title 
Detection rate of psoriatic arthritis in Korean moderate-to-severe 
psoriasis patients, with or without Active Screening for Arthritis in 
Psoriasis (ASAP study) 
Sponsor and Clinical Phase Sponsor - Novartis / Clinical phase - Not applicable 
Investigation type 
Other (Cross-sectional study) 
Study type 
Interventional 
Purpose 
To confirm that the Early Arthritis for Psoriatic Patients (EARP) 
screening is effective in the early diagnosis of Psoriatic Arthritis (PsA) 
Primary Objective(s) 
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 Objectives 
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 design 
This is a randomized, open, parallel, controlled, multi-center, 
interventional, cross-sectional study to evaluate the detection rate of 
PsA in Korean moderate to severe PsO patients with or without 
EARP screening. The participants will be randomized into the EARP 
group and the Routine practice groups. The detection rate of PsA in 
each group is evaluated and compared. 
Study population 
A total of 368 participants who are male and female moderate to 
severe PsO patients aged 19 years or older. 
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 

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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 Intervention 
Screening tool: the EARP questionnaire 
Efficacy assessments 
Primary endpoint: 
• 
Detection rate of PsA 
Secondary endpoint: 
• 
Sensitivity, specificity, PPV and NPV 
• 
Demographic characteristics 
• 
Medications 
• 
PsO related characteristics 
- 
PsO related medical history 
- 
Co-morbidities 
- 
Nail Psoriasis Severity Index (NAPSI) 
- 
SJC66/TJC68 

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Safety assessments 
Not applicable as no drug is involved. 
Data analysis 
The primary objective of this study is to demonstrate that the EARP 
screening is effective in the early diagnosis of PsA.  
The following hypothesis will be tested at a two-sided 0.05 level. 
𝐻𝐻0: 𝑃𝑃𝐼𝐼= 𝑃𝑃𝐶𝐶 𝑣𝑣𝑣𝑣. 𝐻𝐻𝑎𝑎: 𝑃𝑃𝐼𝐼≠𝑃𝑃𝐶𝐶  
where 𝑃𝑃𝐼𝐼 and 𝑃𝑃𝐶𝐶 are the percentage of patients with PsA in each 
EARP group and Routine practice groups, respectively. 
The number and percentage of PsA confirmed by the CASPAR 
criteria for each group are presented and the point-estimate for the 
difference of the proportion between two groups will be given with its 
two-sided 95% Confidence Interval (CI) and the p-value for the null 
hypothesis.  
Analysis on sensitivity, specificity, PPV and NPV will be presented by 
EARP group and Routine practice group. Analysis on the 
demographic characteristics and PsO related characteristics will be 
presented by patients with and without PsA. Descriptive statistics will 
be summarized with the number of patients, mean, standard 
deviation, median, minimum, and maximum for the continuous 
variables and with the number and percentage of patients for the 
categorical variables. The statistical significance for the differences 
between two groups is tested using independent t-test or Wilcoxon 
rank sum test for continuous data and using Chi-square test or 
Fisher's exact test for the categorical data. 
Key words 
Psoriasis, Psoriatic arthritis, Risk, Screening-tools, EARP 

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1 
Introduction 
1.1 
Background 
Psoriatic Arthritis (PsA) is chronic, inflammatory, musculoskeletal disease associated with 
Psoriasis (PsO) (Ritchlin CT, et al. 2017). According to previous studies, between 30% to 41% 
of patients with PsO develop PsA over the course of their lifetime (Haroon M, et al. 2014) 
(Philip J, et al. 2013). Musculoskeletal manifestations of PsA include peripheral arthritis, 
spondylitis, dactylitis and enthesitis (Ogdie A, et al. 2020). Skin manifestations of PsA include 
PsO and nail disease (Ogdie A, et al. 2020). Beyond the musculoskeletal and skin features, 
patients with PsA experience fatigue, physical function limitations, sleep disturbance, as well 
as diminished work capacity and social participation (Orbai AM, et al. 2017).  
The 2015 treatment recommendations of Group for Research and Assessment of Psoriasis and 
Psoriatic Arthritis (GRAPPA) highlight the importance of early diagnosis of PsA as one of the 
six final overarching principles for the care of patients with PsA (Coates LC, et al. 2016a). 
Delayed diagnosis of PsA may result in joint destruction and permanent disabilities, whereas 
early diagnosis and prompt therapy could prevent this irreversible joint damage (Tinazzi I, et 
al. 2012). Several studies conducted on the benefits of early diagnosis of PsA have shown that 
treatment of early stage progressive PsA can substantially improve the long-term prognosis 
(McLaughlin M, et al. 2014) (Theander E, et al. 2014). 
In Korea, the reported prevalence of PsA in PsO patients ranges from 9 to 14.1%, which is 
significantly different from the prevalence in previous studies (Choe YB, et al. 2019). This may 
be due to genetic differences, but may also be due to inadequate screening and diagnosis of PsA 
among PsO patients in Korea (Shin D, et al. 2016).  
The Classification Criteria for Psoriatic Arthritis (CASPAR) were developed by an international 
group of rheumatologists in 2006 to help standardize the diagnosis of PsA. These classification 
criteria consist of two groupings: the stem (or required criteria) consist of inflammatory joint 
(peripheral) disease, enthesitis, and inflammatory axial disease and criteria is associated with a 
numerical value (Mease PJ, et al. 2014) (Taylor W, et al. 2006). To fulfill the CASPAR criteria, 
a patient must present with at least one of the stem components and get 3 points or higher from 
the criteria. The criteria include clinical assessment (current PsO or a personal/family history 
of PsO, psoriatic nail dystrophy, and current dactylitis or history of dactylitis), radiography 
(juxta-articular new-bone formation), and blood test (negative test result for the presence of 
rheumatoid factor). Since skin lesions classically precede joint symptoms, dermatologists are 
in ideal position to play a key role in identifying patients at risk for PsA before irreversible joint 
damage occurs (Busse K, et al. 2010) (Belinchón I, et al. 2020). However, the CASPAR criteria 
are not usually performed routinely in dermatology clinics, so the diagnosis of PsA in PsO 
patients can sometimes be overlooked. Therefore, it seems as though there is a need for a simple 
tool that could assist early and active diagnosis of PsA in dermatology. 
There are several screening tools for PsA; the Psoriasis Epidemiology Screening Tool (PEST), 
the Psoriatic Arthritis Screening and Evaluation (PASE) and the Early Arthritis for Psoriatic 
Patients (EARP) questionnaire. These follow a similar questionnaire structure and have all been 
validated in patients with PsO. Among these, the EARP questionnaire is a simple, user‐friendly 
and easy to administer screening tool. And it focuses on early diagnosis of PsA and has a higher 

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sensitivity than the PASE and PEST questionnaires (Iragorri N, et al. 2018). Thus, the EARP 
questionnaire could assist dermatologists in screening of the potential PsA patients and make 
early diagnosis of PsA. Also, there are studies which have shown that the detection rate of PsA 
can be improved via active screening of PsO patients (Mahmood F, et al. 2017).  
These background information suggest the potential benefit of using EARP questionnaire as a 
screening tool for PsA in everyday dermatology practice. Therefore, it will be helpful to perform 
a clinical trial to compare the rate of PsA diagnosis from the current routine dermatology 
practice in Korea and that from active utilization of PsA screening tool, the EARP. 
1.2 
Purpose 
Delays in diagnosis of PsA can lead to irreversible joint damage, therefore early detection of 
PsA through active screening of arthritis symptoms in PsO patients can be beneficial. The 
EARP is a simple and easy-to-use screening tool which can be utilized in a real-world setting 
of dermatology practice, and it is focused on early diagnosis of PsA. The purpose of this study 
is to confirm that the EARP screening is effective in early diagnosis of PsA.  
2 
Objectives and endpoints  
The objectives of this study and the related endpoints are as follows. 
Table 2–1 
Objectives and related endpoints 
Objective(s) 
Endpoint(s) 
Primary Objective(s) 
• 
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  
 
Endpoint(s) for primary objective(s) 
• 
Detection rate of PsA  
Secondary Objective(s) 
• 
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(s) for secondary objective(s) 
• 
Sensitivity, specificity, PPV and NPV 
• 
Description of demographic characteristics, 
medications and PsO related characteristics  
Detection rate of PsA is defined as the percentage of the subjects with true positive results 
divided by all subjects in each EARP or Routine practice group (=TP/(TP+FP+TN+FN)) 
Sensitivity is defined as the percentage of the subjects with true positive results divided by 
CASPAR score ≥ 3 subjects in each EARP or Routine Practice group (=TP/(TP+FN)) 

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Specificity is defined as the percentage of the subjects with true negative results divided by 
CASPAR score < 3 subjects in each EARP or Routine Practice group (=TN/(TN+FP)) 
PPV is defined as the percentage of the subjects with true positive results divided by EARP ≥ 
3 subjects in the EARP group and as the percentage of the subjects with true positive results 
divided by the subjects suspected of PsA by investigator’s judgement in the Routine Practice 
group (=TP/(TP+FP)) 
NPV is defined as the percentage of the subjects with true negative results divided by EARP < 
3 subjects in the EARP group and as the percentage of the subjects with true negative results 
divided by the subjects not suspected of PSA by investigator’s judgement in the Routine 
Practice group (=TN/(TN+FN)) 
The true positive results are defined as subjects with 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. 
The true negative results are defined as subjects with CASPAR score < 3 among EARP < 3 for 
the EARP group and among those not suspected of PsA by investigator's judgement for the 
Routine Practice group (Table 2-2). 
Table 2–2 
Evaluation outcomes  
EARP group 
 
CASPAR ≥ 3 (positive) 
CASPAR < 3 (negative) 
EARP ≥ 3 (positive) 
TP (True Positive) 
FP (False Positive) 
EARP < 3 (negative) 
FN (False Negative) 
TN (True Negative) 
Routine Practice group 
 
CASPAR ≥ 3 (positive) 
CASPAR < 3 (negative) 
Suspected of PsA by investigator's 
judgement (positive) 
TP (True Positive) 
FP (False Positive) 
Not suspected of PsA by 
investigator's judgement (negative) 
FN (False Negative) 
TN (True Negative) 
 
3 
Study design 
This is a randomized, open, parallel, controlled, multi-center, interventional, cross-sectional 
study to evaluate the detection rate of PsA in Korean moderate to severe PsO patients with or 
without the EARP screening.  
All procedures for each patient will be performed for one day. If an additional time is required 
depending on the circumstances of the institution and so on, the data specified in this study 
protocol are recommended to be collected as soon as possible. After the participants are enrolled 
in this study, they will be assessed whether they meet the inclusion/exclusion criteria. In terms 

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of the severity of PsO, it will be assessed with the Psoriasis Area and Severity Index (PASI) 
and if the score of 10 or higher is defined as moderate to severe PsO. A total 368 eligible 
participants will be randomized 1:1 into the EARP group and the Routine practice groups. 
For the EARP group, the investigator will ask the participants about the EARP questionnaire 
consisting of 10 questions. When the EARP score ≥ 3, the participants will be suspected for 
having potential PsA. For Routine practice group, the investigator will select 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 will be evaluated using CASPAR. According 
to the CASPAR, participants who have inflammatory articular disease with 3 or more points 
from the CASPAR are diagnosed as PsA, and the detection rate of PsA in each group is 
evaluated and compared. 
Figure 3-1 
Study design 
 
4 
Rationale 
4.1 
Rationale for study design 
This is a randomized, open, parallel, controlled, multi-center, interventional, cross-sectional 
study to evaluate the detection rate of PsA in Korean moderate-to-severe PsO patients, with or 
without active screening for arthritis in PsO. 
The EARP questionnaire, an intervention in this study, is used for early diagnosis of PsA. In 
order to evaluate the usefulness of early diagnosis of PsA through the EARP questionnaire, the 
control group is designed to screen subjects suspected of have PsA according to the routine 
practice of real-world dermatology setting. According to the characteristics of the intervention 
used for early diagnosis of PsA in each group, this study is designed as an open study. Therefore, 

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1:1 balanced randomization is planned to compensate for the limitation of the open study and 
to reduce the bias. 
Regarding the study population, this study will include male and female patients with moderate 
to severe PsO. It is confirmed that the PASI score, which evaluates the severity of PsO, was 
significantly higher in PsO patients with PsA than in PsO patients without PsA. This means that 
there is a close relation between the severity of PsO and the prevalence of PsA (Choi JW, et al. 
2017). Therefore, in order to conduct the study on patients expected to have a high prevalence 
of PsA, patients with a PASI score of 10 or higher, defined as moderate to severe PsO patients, 
are selected as a study population. In addition, this study excluded patients who has ever 
received the biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) which may mask 
symptoms of PsA and thus make PsA more difficult to be diagnosed in PsO patients. By 
excluding these patients, the effect of the questionnaire can be confirmed more clearly in the 
real-world setting.  
4.2 
Rationale for Intervention 
According to the 2015 treatment recommendation of GRAPPA, the importance of early 
diagnosis of PsA is emphasized as one of the six final overarching principles for prognosis of 
PsA (Coates LC, et al. 2016a). However, the precise investigation such as radiography and 
rheumatoid factor are required for PsA diagnosis, and this interrupts the early diagnosis of PsA. 
Furthermore, unlike early rheumatoid arthritis where the majority of cases have anti‐
citrullinated protein autoantibodies, a specific marker is absent in early PsA. Therefore, there is 
a greater reliance on clinical assessments in at‐risk groups (Jo SJ et al. 2019), and the need for 
a screening tool of questionnaire has emerged. 
As mentioned above, a various tool has been developed to screen or diagnose PsA in PsO 
patients and the EARP questionnaire is a simple, user‐friendly and easy to administer screening 
tool that can be easily used in dermatology. Furthermore, it focuses on early diagnosis of PsA 
and has a higher sensitivity than the PASE and PEST questionnaires (Iragorri N, et al. 2018). 
Therefore, the EARP screening is selected as an intervention because it is considered to be the 
most applicable screening tool in the real-world dermatology setting in Korea, and it is thought 
that it will result in high early diagnosis rate of PsA. 
4.3 
Rationale for choice of control group 
In this study, the control group is the routine practice group where the PsA screening gets done 
via clinical suspicion of the investigator. 
Typically, patients do not know about the connection between PsO and PsA. Thus, patients 
generally do not inform dermatologists about their PsA symptoms, and often the symptoms of 
PsA are in the early stage which makes PsA difficult to be recognized by the patients. Therefore, 
in routine dermatology practice, PsO patients may get delayed with diagnosis of PsA until they 
develop obvious joint symptoms. With regards to treatment, some dermatologists refer the 
patients to rheumatologists when the patients get noticeable joint symptoms (Jo SJ, et al. 2019). 
However, there are some dermatologists who treat the PsA patients themselves especially those 
in the early stage of the disease. 

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Therefore, we intend to establish the validity of the EARP screening by comparing the PsA 
diagnosis rate in routine dermatological practice and in the EARP screening. 
4.4 
Purpose and timing of interim analyses/design adaptations 
Not applicable 
4.5 
Risks and benefits 
Not applicable 
4.6 
Rationale for Public Health Emergency mitigation procedures 
Not applicable 
5 
Study Population 
The study will include male and female patients with moderate to severe PsO. A total of 368 
patients (184 in each treatment arm) will be randomized at 15 centers across the Korea 
(Depending on the progress of the study, additional sites may be added.).  
The calculation of the sample size is provided in Section 12.8. 
5.1 
Inclusion criteria 
Participants eligible for inclusion in this study must meet all of the following 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 (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) 
5.2 
Exclusion criteria 
Participants meeting any of the following criteria are not eligible for inclusion in this study. 
1. Patients who have formal pre-existing diagnosis of PsA  
2. Patients who have ever received treatment with biologic DMARDs  
3. Patients who currently receive systemic glucocorticoids. 
4. Patients who currently receive opioid analgesics  
5. Patients who have other known pre-existing dermatological or rheumatological diseases 
- 
Non-plaque psoriasis 
- 
Rheumatoid arthritis 
- 
Osteoarthritis 
- 
Gout 
- 
Reactive arthritis 
- 
Ankylosing spondylitis 

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- 
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. 
6 
Study Intervention 
6.1 
Study Intervention 
6.1.1 
EARP group 
The EARP questionnaire will be provided to the investigator in a Korean translated form. For 
the EARP group, the investigator provides this questionnaire to the participants, who will fill 
out this according to their symptoms. The investigator should calculate the total score of the 
questionnaire answered by the participant. After the completion of EARP questionnaire 
evaluation, the participants will be evaluated using the CASPAR. 
6.1.2 
Routine practice group 
In the control group, PsA risk will be assessed in moderate to severe PsO patients as per routine 
practice without using the EARP screening. Routine practice for the treatment of moderate to 
severe PsO patients seldom include active screening for symptoms of PsA using any screening 
questionnaires. Instead of that, the investigator may ask the participants if they have any joint 
pain currently or in the past. After the completion of PsA risk assessment via routine practice 
according to the investigator’s judgement, the participants will be evaluated using the CASPAR. 
6.2 
Participant numbering, randomization 
6.2.1 
Participant numbering 
Each participant is identified in the study by a participant number (Participant No.), that is 
assigned when the participant is enrolled for screening and is retained for the participant 
throughout his/her participation in the study. The Participant No. consists of the site number (as 
assigned by Novartis to the investigative site) with a sequence number suffixed to it, so that 
each participant’s participation is numbered uniquely across the entire database.  
6.2.2 
Randomization 
The randomization numbers will be generated using the following procedure to ensure that 
treatment assignment is unbiased.  
Participants who meet all inclusion criteria and none of the exclusion criteria will be centrally, 
randomly allocated with a 1:1 ratio to either the EARP group or the Routine practice group 
using an Interactive Web Response System (IWRS).  

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The Randomization Number (Randomization No.) consists of the group number and a sequence 
number. An eligible patient will be given the lowest available sequence number. This number 
assigns the patient to one of the groups.  
Randomization will be stratified by the site in order to minimize the bias caused by each 
judgment of investigator.  
6.3 
Blinding 
Assigned group will be open to participants, investigator staff, persons performing the 
assessments and the Novartis clinical trial team (CTT). Such that no aggregate statistical 
analyses by treatment shall be performed prior to the database lock. 
7 
Informed consent procedures 
Eligible participants may only be included in the study after providing (witnessed, where 
required by law or regulation), Institutional Review Board (IRB)-approved informed consent. 
In cases where the participant's representative(s) gives consent, the participant must be informed 
about the study to the extent possible given his/her level of understanding. If the participant is 
capable of doing so, he/she must indicate agreement by personally signing and dating the 
written informed consent document. 
Informed consent must be obtained before conducting any study-specific procedures (e.g. all of 
the procedures described in the protocol). The process of obtaining informed consent must be 
documented in the participant source documents. 
Novartis will review the Contract Research Organization (CRO) proposed ICF to ensure it 
complies with the International Council for Harmonization of Technical Requirements for 
Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice (GCP) guidelines and 
regulatory requirements and is considered appropriate for this study. Any further changes to the 
proposed consent form suggested by the investigator must be agreed to by Novartis before 
submission to the IRB. 
8 
Visit schedule and assessments 
The assessment schedule (Table 8–1) lists all of the assessments when they are performed. All 
data obtained from these assessments must be supported in the participant’s source 
documentation. 
All baseline assessments may occur during the screening, and all procedures for each participant 
is performed for one day (Visit 1). If an additional time is required depending on the 
circumstances of the institution and so on, the data specified in this study protocol are 
recommended to be collected as soon as possible. 
Participants should be seen for all assessments as outlined in the assessment schedule (Table 8–
1).

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Table 8–1 
Assessment schedule  
Period 
Screening 
Randomization Intervention 
Physical 
examination 
Evaluation 
Visit Name 
Visit 1 
Day/Week/Month 
Day 1 
Obtain informed consent 1) 
X 
 
 
 
 
Demographics 
Year of birth, age 
X 
 
 
 
 
Sex 
X 
 
 
 
 
Height (cm) 
X 
 
 
 
 
Weight (kg) 
X 
 
 
 
 
Body Mass Index (BMI) 
X 
 
 
 
 
Alcohol consumption status 
X 
 
 
 
 
Smoking status 
X 
 
 
 
 
Pregnancy tests 2) 
X 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
Medical history and 
medication 3) 
Medical history 
X 
 
 
 
 
PsO related medical history 
X 
 
 
 
 
Medications 
X 
 
 
 
 
PsO related treatment other than 
medications 
X 
 
 
 
 
Randomization 
 
X 
 
 
 
Intervention 
EARP screening  
(EAPR group) 
 
 
X 
 
 
Investigator’s judgement 
(Routine practice group) 
 
 
X 
 
 
Physical examination 
NAPSI 
 
 
 
X 
 
SJC66 
 
 
 
X 
 
TJC68 
 
 
 
X 
 

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Period 
Screening 
Randomization Intervention 
Physical 
examination 
Evaluation 
Visit Name 
Visit 1 
Day/Week/Month 
Day 1 
CASPAR 4) 
Clinical assessment 
 
 
 
 
X 
Blood test 
 
 
 
 
X 
Radiography 
 
 
 
 
X 
PsO; Psoriasis; EARP: Early arthritis for psoriatic patients; NAPSI: Nail psoriasis severity index; SJC: Swollen joint count; TJC: Tender joint count; CASPAR: 
Classification criteria for psoriatic arthritis; PsA: Psoriatic arthritis  
1) All procedures must be conducted after getting ICF, and participant numbers are assigned in the order of consent. 
2) For all female patients of child bearing potential only, a urine-HCG test will be performed. 
3) Medical history and medication 
• 
Medical history: Heart diseases, stroke, diabetes, hyperlipidemia, hypertension, fatty liver and other diseases 
• 
PsO related medical history: Date of diagnosis for PsO, family history of PsO, family history of PsA, PASI score, hard-to-treat area involvement 
(scalp, palmoplantar and nails), musculoskeletal symptoms  
• 
Medications 
• 
PsO related treatment other than medications 
4) CASPAR: Based on the CASPAR, participants are diagnosed with or without PsA. 
• 
Clinical assessment: Inflammatory articular disease (inflammatory joint (peripheral) disease, enthesitis, and inflammatory axial disease), date of 
diagnosis for PsO#, family history of PsO#, presence or absence of typical psoriatic nail dystrophy (onycholysis, pitting, hyperkeratosis), presence 
or absence of dactylitis, history of dactylitis (recorded by rheumatologist) 
• 
Blood test: Rheumatoid factor 
• 
Radiography: Hand and foot plain X-ray (evidence of juxta-articular new bone formation in hand (including wrist) and feet (including ankle)) 
Note) #: These values which are included the CASPAR are replaced by the values in Section 8.2.2.2. 
 

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8.1 
Screening 
All procedures must be conducted after getting ICF, and participant numbers are assigned in 
the order of consent. Screening is performed to assess inclusion/exclusion criteria (Refer to the 
value of Section 8.2). 
8.1.1 
Information to be collected on screening failures 
Participants who sign an ICF and subsequently found to be ineligible prior to randomization 
will be considered a screen failure. The reason for screen failure should be recorded on the 
electronic case report form (eCRF). The demographic information, informed consent, and 
inclusion/exclusion pages must also be completed for screen failure participants.  
Participants who are randomized and fail to start study (e.g., participants randomized in error) 
will be considered an early terminator. The reason for early termination should be recorded on 
the eCRF. 
8.2 
Participant demographics/other baseline characteristics 
The following patient demographic and other baseline characteristics data will be collected on 
all participants. 
8.2.1 
Demographic characteristics 
The following information will be collected/documented at screening for each patient: 
• 
Year of birth 
• 
Age 
• 
Sex 
• 
Height (cm) 
• 
Weight (kg) 
• 
BMI 
• 
Alcohol consumption status (current drinker, past-drinker or non-drinker) 
• 
Smoking status (current smoker, ex-smoker or never smoked) 
8.2.2 
Medical history and medication 
8.2.2.1 
Medical history 
• 
Heart diseases (presence or absence/start date/end date/ongoing or not) 
• 
Stroke (presence or absence/start date/end date/ongoing or not) 
• 
Diabetes (presence or absence/start date/end date/ongoing or not) 
• 
Hyperlipidemia (presence or absence/start date/end date/ongoing or not) 
• 
Hypertension (presence or absence/start date/end date/ongoing or not) 

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• 
Fatty liver (presence or absence/start date/end date/ongoing or not) 
• 
Other diseases (presence or absence/disease name/start date/end date/ongoing or not)  
8.2.2.2 
PsO related medical history 
• 
Date of diagnosis for PsO 
• 
Family history of PsO 
• 
Family history of PsA 
• 
PASI score 
• 
Hard-to-treat area involvement (presence or absence of scalp, palmoplantar and nails) 
• 
Musculoskeletal symptoms (presence or absence/site) 
8.2.2.3 
Medications 
• 
Presence or absence of medications 
• 
Drug name 
• 
Daily dose 
• 
Route of administration 
• 
Administration period (start date/end date/ongoing or not) 
• 
Purpose of administration (PsO related/others) 
8.2.2.4 
PsO related treatment other than medications 
• 
Presence or absence of PsO related treatment 
• 
Treatment name 
• 
Treatment period (start date/end date/ongoing or not) 
8.3 
EARP 
The EARP is a questionnaire composed of ten questions regarding symptoms of joint disease, 
developed for the early diagnosis of PsO. This questionnaire consists of simple questions, and 
it has 0-10 range (Tinazzi I, et al. 2012). 
In this study, the EARP screening is only conducted on the EARP group, and when the EARP 
score ≥ 3, it can be judged that the patients is potential PsA. The Korean EARP questionnaire 
is included in Appendix 1. EARP questionnaire. 
• 
EARP score 

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8.4 
Physical examinations 
8.4.1 
NAPSI 
The nails will be visually inspected, and if an abnormality is observed, a photograph will be 
obtained and will be evaluated by investigator using NAPSI. 
NAPSI is a numeric, reproducible, objective, simple tool for evaluation of nail PsO. This scale 
is used to evaluate the severity of nail bed PsO and nail matrix PsO by area of involvement in 
the nail unit. The nail is divided with imaginary horizontal and longitudinal lines into quadrants. 
Each nail is given a score for nail bed PsO (0-4) and nail matrix PsO (0-4) depending on the 
presence of any of the features of nail PsO in that quadrant (Rich P, et al. 2003). A total score 
per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included). 
In this study, NAPSI is measured for all participants. 
• 
Score of left hand 
• 
Score of right hand 
• 
Score of left foot 
• 
Score of right foot 
• 
Total score 

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Figure 8-1 
NAPSI score 
 
8.4.2 
SJC66/TJC68 
The SJC66/TJC68 is the first instrument fully endorsed within the PsA core outcome 
measurement set. The 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 (Duarte-García A, et al. 2019).  
In this study, SJC66/TJC68 gets measured for all participants. 
• 
SJC66: number of swollen joints 
• 
TJC68: number of tender joints 

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Figure 8-2 
SJC66/TJC68 score 
 
8.5 
Efficacy 
All efficacy assessments should be recorded in the eCRF. The methods of evaluation and the 
primary and secondary parameter to be assessed are listed in this section. 
8.5.1 
Primary endpoint 
The primary endpoint of this study is detection rate of PsA. The assessments are measured by 
the CASPAR including clinical assessment, radiography and blood test. In addition, some 
values which are included the CASPAR are replaced by the values in Section 8.2. 
8.5.1.1 
CASPAR 
In this study, the CASPAR will be measured for all participants after the EARP questionnaire 
evaluation and the investigator’s judgement are completed in each group. The details of the 
CASPAR scoring are in the Table 8–2 (Cantini F, et al. 2010). 
Table 8–2 
CASPAR score 
To meet the CASPAR, a patient must have an inflammatory articular disease (inflammatory joint 
(peripheral) disease, enthesitis, or inflammatory axial disease) with ≥ 3 points from the above criteria. 
Criteria 
Point 
Current PsO 
2 
Personal history of PsO 
1 

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To meet the CASPAR, a patient must have an inflammatory articular disease (inflammatory joint 
(peripheral) disease, enthesitis, or inflammatory axial disease) with ≥ 3 points from the above criteria. 
Criteria 
Point 
Family history of PsO 
1 
Typical PsO nail dystrophy (onycholysis, pitting, hyperkeratosis) 
1 
Current dactylitis or history of dactylitis 
1 
Negative rheumatoid factor 
1 
Hand and foot plain radiography (evidence of juxta-articular new bone formation 
in hand (including wrist) and feet (including ankle)) 
1 
The items for the CASPAR measurement are as follows. 
• 
Clinical assessment 
Inflammatory joint disease (presence or absence of Inflammatory joint (peripheral) 
disease, enthesitis and inflammatory axial disease), date of diagnosis for PsO#, family 
history of PsO#, presence or absence of typical psoriatic nail dystrophy (onycholysis, 
pitting, hyperkeratosis), presence or absence of dactylitis, history of dactylitis  
• 
Blood test 
Rheumatoid factor 
• 
Radiography 
Hand and foot plain X-ray (evidence of juxta-articular new bone formation in hand 
(including wrist) and feet (including ankle)) 
Note) #: These values which are included the CASPAR are replaced by the values in Section 8.2.2.2. 
8.5.2 
Secondary endpoint 
The secondary endpoints of this study are as follows. 
• 
Sensitivity, specificity, PPV and NPV 
• 
Description of demographic characteristics, medications and PsO related characteristics 
Sensitivity, specificity, PPV and NPV will use CASPAR to determine PsA diagnosis, and be 
compared between EARP questionnaire (EARP group) and the investigator's judgement 
(Routine practice group) (Section 8.5.1.1). 
Description of demographic characteristics, medications and PsO related characteristics will be 
compared between PsA and non-PsA patients. Details of the variables are in Section 8.5.2.1 to 
8.5.2.3 and the assessment will be measured by the values in Section 8.2 and 8.4. 
8.5.2.1 
Demographic characteristics 
• 
Age 
• 
Sex 
• 
BMI 

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• 
Alcohol consumption status 
• 
Smoking status 
8.5.2.2 
Medications 
• 
Drug name 
8.5.2.3 
PsO related characteristics 
PsO related medical history 
• 
Duration of PsO 
• 
Family history of PsO 
• 
Family history of PsA  
• 
PASI score 
• 
Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) 
• 
Presence or absence of musculoskeletal symptoms 
• 
Presence or absence of PsO related treatment other than medications  
Co-morbidities 
• 
Presence or absence of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, 
hypertension, fatty liver) 
NAPSI 
• 
Total Score 
SJC66/TJC68 
• 
SJC66: number of swollen joints 
• 
TJC68: number of tender joints 
8.6 
Safety 
Safety assessment is not applicable as no drug is involved. 
8.7 
Additional assessments 
No additional tests will be performed on participants entered into this study. 
9 
Discontinuation and completion  
9.1 
Discontinuation from study treatment and from study 
Not applicable 

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9.2 
Withdrawal of informed consent/Opposition to use 
data/biological samples  
Withdrawal of consent/opposition to use data occurs when a participant: 
• Explicitly requests to stop the use of their data (opposition to use participant’s data) 
and 
• No longer wishes to participate in this study 
This request should be in writing (depending on local regulations) and recorded in the source 
documentation. 
In this situation, the investigator should make a reasonable effort to understand the primary 
reason for the participant’s decision to withdraw their consent/opposition to use data and record 
this information. 
Where consent to the use of Personal and Coded Data is not required in a certain country's legal 
framework, the participant therefore cannot withdraw consent. However, they still retain the 
right to object to the further collection or use of their Personal Data. 
Study must be discontinued and no further assessments conducted. 
Novartis will continue to retain and use all research results (data) that have already been 
collected for the study evaluation. No new Personal Data will be collected following withdrawal 
of consent/opposition. 
9.3 
Study completion and post-study treatment 
The study will be considered completed when the last participant enrolled in the study visits 
and performs the last assessment. Participation in this study has no impact on the type of 
medical care that the participant will receive during study as well as post-study participation. 
9.4 
Early study termination by the sponsor 
The study can be terminated by Novartis at any time. 
This study is completed after one visit for each participant, and there is no effect on the safety 
or welfare of the participants due to the study ending after single visit. The investigator or 
sponsor depending on local regulation will be responsible for informing IRBs of the early 
termination of the trial. 
10 
Safety monitoring, reporting and committees 
10.1 
Definition of adverse events and reporting requirements  
Not applicable 
10.2 
Additional Safety Monitoring  
Not applicable 

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10.3 
Committees 
Not applicable 
11 
Data Collection and Database management  
11.1 
Data collection 
Designated investigator staff will enter the data required by the protocol into the eCRF. The 
eCRFs have been built using fully validated secure web-enabled software that conforms to 21 
CFR Part 11 requirements, Investigator site staff will not be given access to the Electronic Data 
Capture (EDC) system until they have been trained. Automatic validation programs check for 
data discrepancies in the eCRFs, allow modification and/or verification of the entered data by 
the investigator staff. 
The investigator/designee is responsible for assuring that the data entered into eCRF is complete, 
accurate, and that entry and updates are performed in a timely manner. The Investigator must 
certify that the data entered are complete and accurate. 
After final database lock, the investigator will receive copies of the participant data for 
archiving at the investigational site. 
All data should be recorded, handled, and stored in a way that allows its accurate reporting, 
interpretation, and verification. 
11.2 
Database management and quality control  
Novartis personnel (or designated CRO) will review the data entered by investigational staff 
for completeness and accuracy. Electronic data queries stating the nature of the problem and 
requesting clarification will be created for discrepancies and missing values and sent to the 
investigational site via the EDC system. Designated investigator site staff are required to 
respond promptly to queries and to make any necessary changes to the data. 
The medications entered into the database will be coded using the World Health Organization 
(WHO) Drug Reference List, which employs the Anatomical Therapeutic Chemical 
classification system. Medical history/current medical conditions and adverse events will be 
coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. 
Once all the necessary actions have been completed and the database has been declared to be 
complete and accurate, it will be locked. Any changes to the database after that time can only 
be made after written agreement by Novartis development management. 
11.3 
Site monitoring 
Before study initiation, at a site initiation visit or at an investigator’s meeting, a Novartis/CRO 
representative will review the protocol and data capture requirements (i.e. eCRFs) with the 
investigators and their staff. During the study, Novartis employs several methods of ensuring 
protocol and GCP compliance and the quality/integrity of the sites’ data. The field monitor will 
visit the site to check the completeness of participant records, the accuracy of data capture / 
data entry, the adherence to the protocol and to GCP, the progress of enrollment, and to ensure 

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that study treatment is being stored, dispensed, and accounted for according to specifications. 
Key study personnel must be available to assist the field monitor during these visits.  
The investigator must maintain source documents for each participant in the study, consisting 
of case and visit notes (hospital or clinic medical records) containing demographic and medical 
information, laboratory data, and the results of any other tests or assessments. All information 
on CRFs must be traceable to these source documents in the participant's file. The investigator 
must also keep the original ICF signed by the participant (a signed copy is given to the 
participant). 
The investigator must give the monitor access to all relevant source documents to confirm their 
consistency with the data capture and/or data entry. Novartis monitoring standards require full 
verification for the presence of informed consent, adherence to the inclusion/exclusion criteria 
and of data that will be used for all primary variables. Additional checks of the consistency of 
the source data with the CRFs are performed according to the study-specific monitoring plan. 
No information in source documents about the identity of the participants will be disclosed. 
12 
Data analysis and statistical methods 
All analyses will be performed by a designated CRO. 
Descriptive statistics will include n, mean, standard deviation, median, minimum, and 
maximum for continuous variables and the number and percentage of patients for categorical 
variables. If necessary, more detailed information will be provided. Statistical comparisons 
between two groups for continuous variables will be made using independent t-test or Wilcoxon 
rank sum test, and that for categorical variables using Chi-square test or Fisher’s exact test. All 
the statistical tests will use a two-sided test at the significance level of 0.05.  
Missing data will not be imputed, and all statistical analyses will be performed using available 
data. 
Further technical details will be specified in the Statistical Analysis Plan, which will be finalized 
prior to database lock. 
12.1 
Analysis sets 
The data obtained from this study will be analyzed for the full analysis set (FAS) and per-
protocol set (PPS). The efficacy analysis will be performed using the FAS and PPS and the 
primary efficacy population is the FAS.  
• 
The FAS will consist of all patients as randomized who had assessment for the primary 
endpoint. 
• 
The PPS will consist of all patients in the FAS who completed the study without major 
protocol deviations. 
12.2 
Participant demographics and other baseline characteristics  
Analysis on demographic characteristics and PsO related characteristics will be conducted on 
the FAS and presented by interventional group and overall. 

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• 
Demographic characteristics include age, sex, height (cm), weight (kg), BMI, alcohol 
consumption status and smoking status. 
• 
PsO related characteristics include duration of PsO, family history of PsO, family 
history of PsA, PASI score, status of hard-to-treat area involvement (scalp, 
palmoplantar and nails), status of musculoskeletal symptoms, NAPSI (left hand, right 
hand, left foot, right foot and total), SJC66, TJC68, status of co-morbidities (heart 
diseases, stroke, diabetes, hyperlipidemia, hypertension and fatty liver), and status of 
PsO related treatment other than medications. 
Continuous variables will be summarized with the number of patients, mean, standard deviation, 
median, minimum, and maximum and categorical variables will be summarized with the 
number and percentage of patients. Statistical comparisons between two groups for continuous 
variables will be made using independent t-test or Wilcoxon rank sum test and that for 
categorical variables using Chi-square test or Fisher’s exact test. 
In addition, the number and percentage of patients having at least one prior and ongoing PsO 
related treatment other than medications will be tabulated by system organ class and preferred 
term of the MedDRA dictionary. The number and percentage of patients having at least one 
prior and ongoing medication will be tabulated by therapeutic main group and preferred term 
of the WHO drug dictionary. 
12.3 
Treatments  
Not applicable 
12.4 
Analysis supporting primary objectives 
The main objective of this study is to compare the detection rate of PsA amongst moderate to 
severe PsO patients between the EARP group and the Routine practice groups. 
12.4.1 
Definition of primary endpoint(s) 
The primary endpoint of the study is the detection rate of PsA 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 are defined as patients with 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. 
12.4.2 
Statistical model, hypothesis, and method of analysis 
The following hypothesis will be tested at a two-sided 0.05 level. 
𝐻𝐻0: 𝑃𝑃𝐼𝐼= 𝑃𝑃𝐶𝐶 𝑣𝑣𝑣𝑣. 𝐻𝐻𝑎𝑎: 𝑃𝑃𝐼𝐼≠𝑃𝑃𝐶𝐶  
where 𝑃𝑃𝐼𝐼 and 𝑃𝑃𝐶𝐶 are the percentage of patients with PsA in each EARP group and Routine 
practice group, respectively. 
The number and percentage of patients with PsA will be presented by each group using the FAS. 
The point-estimate for the difference of proportion between two groups (EARP group – Routine 

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practice group) will be given with its two-sided 95% Confidence Interval (CI) and the p-value 
for the null hypothesis. Superiority will be claimed if the lower limit of the CI is greater than 0. 
The primary analysis will be repeated for the PPS using the same model as the one used for the 
primary analysis. 
12.4.3 
Sensitivity analyses  
Not applicable 
12.4.4 
Supplementary analysis  
Not applicable 
12.5 
Analysis supporting secondary objectives  
12.5.1 
Sensitivity, specificity, PPV and NPV 
Analysis on sensitivity, specificity, PPV and NPV will be performed on the FAS and PPS and 
presented by EARP group and Routine practice group. 
Sensitivity will be 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 will be 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) will be 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) will be summarized with the number and percentage of 
patients who have true negative (TN) among those who have true negative (TN) and false 
negative (FN). 
The statistical significance for the differences between two groups is tested using Chi-square 
test or Fisher's exact test. 
12.5.2 
Demographic characteristics and PsO related characteristics  
Analysis on the demographic characteristics and PsO related characteristics will be performed 
on the FAS and PPS and presented by patients with and without PsA.  
The following demographic characteristics and PsO related characteristics will be included. 
• 
Demographic characteristics include age, sex, BMI, alcohol consumption status and 
smoking status. 
• 
PsO related characteristics include duration of PsO, family history of PsO, family 
history of PsA, PASI score, status of hard-to-treat area involvement (scalp, 
palmoplantar and nails), status of musculoskeletal symptoms, NAPSI (total), SJC66, 
TJC68, status of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, 
hypertension and fatty liver), and status of PsO related treatment other than 
medications. 

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Continuous variables will be summarized with the number of patients, mean, standard deviation, 
median, minimum, and maximum and categorical variables will be summarized with the 
number and percentage of patients. The statistical significance for the differences between two 
groups is tested using independent t-test or Wilcoxon rank sum test for continuous data and 
using Chi-square test or Fisher's exact test for the categorical data.  
In addition, the number and percentage of patients having at least one prior and ongoing PsO 
related treatment other than medications will be tabulated by system organ class and preferred 
term of the MedDRA dictionary. The number and percentage of patients having at least one 
prior and ongoing medication will be tabulated by therapeutic main group and preferred term 
of the WHO drug dictionary. 
12.6 
Interim analyses 
No interim analysis will be performed. 
12.7 
Sample size calculation 
According to previous studies, the prevalence of PsA among PsO patients in Korea ranged from 
9.0% to 14.1% (9.0% in Back HJ, et al. 2000, 10.8% in Oh et al. 2017, 13.5% in Choi et al. 
2017, 14.1% in Choi HJ, et al. 2008) (Back HJ, et al. 2000) (Oh EH, et al. 2017) (Choi JW, et 
al. 2017) (Choi HJ, et al. 2008). Considering that this study excludes patients who have received 
treatment with biologic DMARDs to reduce any confounding as trying to demonstrate the 
usefulness of the EARP as an early diagnosis tool for PsA, the detection rate of PsA among 
patients with PsO is assumed to be 9% in the Routine practice group. 
For the EARP group, the detection rate of PsA among PsO patients is assumed to be 19.7%, 
given that in a recent large meta-analysis of 266 studies worldwide, the overall prevalence of 
PsA among PsO patients was reported as 19.7% (Alinaghi F, et al. 2019). Several studies and 
meta-analyses revealed that undiagnosed PsA is common in patients with PsO and between 9% 
and 13.76% of patients with PsO may have undiagnosed PsA (9% in Sleman et al. 2015, 10.1% 
in Coates et al. 2016, 12.4% in Mease et al. 2013, 13.76% in Alshaikh et al. 2020) (Spelman L, 
et al. 2015) (Coates LC, et al. 2016b) (Mease PJ, et al. 2017) (Alshaikh AF, et al. 2020). Thus, 
it would be a reasonable assumption that the detection rate of PsA among patients with PsO 
will increase to 19.7% in the EARP group if the EARP screening will improve the detection 
rate by around 11%. 
Based on a two-sided alpha=0.05 and power 1-β=0.80, assuming the PsA detection rates of 9% 
and 19.7% in the Routine practice and EARP groups, respectively, the sample size of this study 
is estimated to be about 165 per group. 
 
𝑛𝑛=
൫𝑍𝑍𝛼𝛼/2 + 𝑍𝑍𝛽𝛽൯
2(𝑃𝑃𝐶𝐶∗(1 −𝑃𝑃𝐶𝐶) + 𝑃𝑃𝐼𝐼∗(1 −𝑃𝑃𝐼𝐼))
(𝑃𝑃𝐶𝐶−𝑃𝑃𝐼𝐼)2
=
(1.96 + 0.842)2(0.09 ∗(1 −0.09) + 0.197 ∗(1 −0.197))
(0.09 −0.197)2
= 164.64 
 
Considering 10% of invalid cases, a total of 368 patients (184 patients per group) is planned to 
be enrolled in this study. 

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13 
Ethical considerations and administrative procedures  
13.1 
Regulatory and ethical compliance  
This clinical study was designed and shall be implemented, executed and reported in accordance 
with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, and 
with the ethical principles laid down in the Declaration of Helsinki. 
13.2 
Responsibilities of the investigator and IRB  
Before initiating a trial, the investigator/institution must obtain approval/favorable opinion from 
the IRB for the trial protocol, written ICF, consent form updates, participant recruitment 
procedures (e.g., advertisements) and any other written information to be provided to 
participants. Prior to study start, the investigator is required to sign a protocol signature page 
confirming his/her agreement to conduct the study in accordance with these documents and all 
of the instructions and procedures found in this protocol and to give access to all relevant data 
and records to Novartis monitors, auditors, Novartis Quality Assurance representatives, 
designated agents of Novartis, IRBs, and regulatory authorities as required. 
13.3 
Publication of study protocol and results  
The protocol will be registered in a publicly accessible database such as clinicaltrials.gov. In 
addition, after study completion (defined as last patient last visit) and finalization of the study 
report the results of this trial will be submitted for publication and posted in a publicly accessible 
database of clinical trial results, such as the Novartis clinical trial results website and all required 
Health Authority websites (e.g. Clinicaltrials.gov, EudraCT etc.). 
For details on the Novartis publication policy including authorship criteria, please refer to the 
Novartis publication policy training materials that were provided to you at the trial investigator 
meetings. 
13.4 
Quality Control and Quality Assurance  
Novartis maintains a robust Quality Management System (QMS) that includes all activities 
involved in quality assurance and quality control, to ensure compliance with written Standard 
Operating Procedures as well as applicable global/local GCP regulations and ICH Guidelines. 
Audits of investigator sites, vendors, and Novartis systems are performed by auditors, 
independent from those involved in conducting, monitoring or performing quality control of the 
clinical trial. The clinical audit process uses a knowledge/risk based approach. 
Audits are conducted to assess GCP compliance with global and local regulatory requirements, 
protocols and internal Standard Operating Procedures (SOPs), and are performed according to 
written Novartis processes. 
13.5 
Participant Engagement  
Not applicable 

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14 
Protocol adherence  
This protocol defines the study objectives, the study procedures and the data to be collected on 
study participants. Additional assessments required to ensure safety of participants should be 
administered as deemed necessary on a case by case basis. Under no circumstances including 
incidental collection is an investigator allowed to collect additional data or conduct any 
additional procedures for any purpose involving any investigational drugs under the protocol, 
other than the purpose of the study. If despite this interdiction prohibition, data, information, 
observation would be incidentally collected, the investigator shall immediately disclose it to 
Novartis and not use it for any purpose other than the study, except for the appropriate 
monitoring on study participants. 
Investigators ascertain they will apply due diligence to avoid protocol deviations. If an 
investigator feels a protocol deviation would improve the conduct of the study this must be 
considered a protocol amendment, and unless such an amendment is agreed upon by Novartis 
and approved by the IRB and Health Authorities, where required, it cannot be implemented. 
14.1 
Protocol amendments  
Any change or addition to the protocol can only be made in a written protocol amendment that 
must be approved by Novartis, health authorities where required, and the IRB prior to 
implementation. 
Only amendments that are required for participant safety may be implemented immediately 
provided the health authorities are subsequently notified by protocol amendment and the 
reviewing IRB is notified. 
Notwithstanding the need for approval of formal protocol amendments, the investigator is 
expected to take any immediate action required for the safety of any participant included in this 
study, even if this action represents a deviation from the protocol. In such cases, Novartis should 
be notified of this action and the IRB at the study site should be informed according to local 
regulations. 

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15 
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Tinazzi I, Adami S, Zanolin EM, et al (2012) The early psoriatic arthritis screening 
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Appendix 1. EARP questionnaire 
EARP 
 
 
Tinazzi I, et al. The early psoriatic arthritis screening questionnaire: a simple and fast method for the 
identification of arthritis in patients with psoriasis. Rheumatology 2012;51:2058–2063. 
doi:10.1093/rheumatology/kes187