Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
Conditions: Psoriatic Arthritis
Sponsor: University of Pennsylvania

PARC-B 
Psoriatic Arthritis Research Collaborative: Biologic Sub-Study 
 
NCT03378336 
 
Study Protocol and Statistical Analysis Plan 
August 14, 2019 
 

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Modiﬁcation
Basic Info
Conﬁrmation Number:
cjdfhgga
Protocol Number:
828357
Created By:
BUSH, KATHLEEN
Principal Investigator:
OGDIE-BEATTY, ALEXIS
Protocol Title:
Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
Short Title:
PARC-B
Protocol Description:
Psoriatic arthritis (PsA) is an inﬂammatory arthritis with substantial variation in clinical 
features. We propose a multicenter collaborative approach to better understand the phenotypes 
and current management of PsA in the United States.The central goal of this proposal is to obtain 
the data necessary to design a pragmatic trial in PsA.
Submission Type:
Biomedical Research
Application Type:
PRIME
PennERA Protocol Status
Approved
Resubmission*
No
Are you submitting a Modiﬁcation to this protocol?*
Yes
Current Status of Study
Study Status
Currently in Progress
If study is currently in progress, please enter the following
Number of subjects enrolled at Penn since the study was initiated
0
Actual enrollment at participating centers
0
If study is closed to further enrollment, please enter the following
Number of subjects in therapy or intervention
0
Number of subjects in long-term follow-up only
0

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IRB Determination
If the change represents more than minimal risk to subjects, it must be reviewed and approved by the 
IRB at a convened meeting. For a modiﬁcation to be considered more than minimal risk, the proposed 
change would increase the risk of discomfort or decrease beneﬁt. The IRB must review and approve the 
proposed change at a convened meeting before the change can be implemented unless the change is 
necessary to eliminate an immediate hazard to the research participants. In the case of a change 
implemented to eliminate an immediate hazard to participants, the IRB will review the change to 
determine that it is consistent with ensuring the participant&prime;s continued welfare. Examples: 
Convened Board Increase in target enrollment for investigator initiated research or potential Phase I 
research Expanding inclusion or removing exclusion criteria where the new population may be at 
increased risk Revised risk information with active participants Minor risk revisions that may affect a 
subject&prime;s willingness to continue to participate Expedited Review Increase in target enrollment 
at Penn where overall enrollment target is not exceeded or potentially sponsored research Expanding 
inclusion or removing exclusion where the new population has the same expected risk as the previous, 
based on similarities of condition Revised risk information with subjects in long-term follow-up Minor 
risk revisions with no subjects enrolled to date 
Expedited Review
Modiﬁcation Summary
Please describe any required modiﬁcation to the protocol. If you are using this form to submit an 
exception or report a deviation, enter 'N/A' in the box below.
Updating Personnel
Risk / Beneﬁt
Does this amendment alter the Risk/Beneﬁt proﬁle of the study?
No
Change in Consent
Has there been a change in the consent documents?
No
If YES, please choose from the options below regarding re-consenting
Deviations
Are you reporting a deviation to this protocol?*
No
Exceptions
Are you reporting an exception to this protocol?*
No

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Protocol Details
Resubmission*
Yes
Study Personnel
Principal Investigator
Name:
OGDIE-BEATTY, ALEXIS
Dept / School / Div:
4261 - DM-Rheumatology
Campus Address
Mail Code
4385
Address:
3400 Spruce Street
5 White
City State Zip:
Philadelphia PA 19104-4385
Phone:
215-615-4375
Fax:
-
Pager:
Email:
Alexis.Ogdie@uphs.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
11/15/2015
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Study Contacts
Name:
BUSH, KATHLEEN
Dept / School / Div:
4261 - DM-Rheumatology
Campus Address
Mail Code
4283
Address:
Floor 5 3400 Spruce Street 
HUP White- Room 5016 
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
-
Fax:
-
Pager:
Email:
katbu@pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
09/09/2017
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA

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Name:
HOPKINS, SARAH C
Dept / School / Div:
4261 - DM-Rheumatology
Campus Address
Mail Code
4283
Address:
3400 Spruce Street
3400 SPRUCE ST 
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
Fax:
4283
Pager:
Email:
sarah.hopkins@pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
07/08/2022
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Name:
ALMONTE, MICHELE D
Dept / School / Div:
4261 - DM-Rheumatology
Campus Address
Mail Code
4283
Address:
3400 Spruce Street 
University of Pennsylvania Whi
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
Fax:
Pager:
Email:
Michele.Almonte@uphs.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
02/12/2022
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
Other Investigator
Name:
GEORGE, MICHAEL
Dept / School / Div:
4261 - DM-Rheumatology
Campus Address
Mail Code
4283
Address:
HUP 
3400 SPRUCE ST 
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
-
Fax:
-
Pager:
Email:
michael.george@uphs.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
08/04/2019
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA

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Responsible Org (Department/School/Division):
4261 - DM-Rheumatology
Key Study Personnel
Name:
CRAIG, ETHAN T
Department/School/Division:
DM-Rheumatology
HS Training Completed:
Yes
Training Expiration Date:
09/12/2021
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Name:
LUO, DEE
Department/School/Division:
Health System
HS Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
DURKIN, CLAIRE
Department/School/Division:
Health System
HS Training Completed:
Yes
Training Expiration Date:
06/09/2022
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
Biomedical Research
Clinical Trial*
Is this a clinical trial?
Yes
If Yes, please be aware that for each clinical trial conducted or supported by a Federal department or 
agency, one IRB-approved informed consent form used to enroll subjects must be posted by the 
awardee or the Federal department or agency component conducting the trial on a publicly available 

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Federal Web site that will be established as a repository for such informed consent forms.
Investigator Initiated Trial*
Is this an investigator initiated trial?
Yes
If Yes, please be aware that the investigator may be required to create and manage a record of this trial 
in https://clinicaltrials.gov.
Drugs or Devices*
Does this research study involve Drugs or Devices?
No
IND Exemption
For studies that fall under an IND exemption, please provide the number below
For studies including IND or IDE's, please provide the number(s) below
IDE Review*
NOTE: For research involving investigational devices, you are required to review the guidance on 
Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https://
www.med.upenn.edu/pennmanual/secure/investigational-product-management-at-sites-not-using-
investigational-drug-services-(ids).html Please check the box Yes if you have reviewed the guidance.
Yes
Research Device Management*
Please indicate how research device(s) will be managed.
Not Applicable (no investigational devices)
Drug, Herbal Product or Other Chemical Element Management *
Please indicate how drugs, herbal products or other chemical entities will be managed.
Not Applicable (no drugs, herbal products or other chemical entities)
Radiation Exposure*
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol?
No
Gene Transfer*
Does this research involve gene transfer (including all vectors) to human subjects?
No
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)?
Yes
CACTIS and CT Studies*
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) 
and CT studies that research subjects would not receive if they were not part of this protocol?
No
CAMRIS and MRI Studies*
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this 
protocol?
No

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Investigational Agent or Device within the Operating Room*
Does the research project involve the use of an investigational agent or device within the Operating 
Room?
No
Cancer Related research not being conducted by an NCI cooperative group*
Does this protocol involve cancer-related studies in any of the following categories?
No
Processing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
In-House Manufacturing of Materials*
Will the research involve processing (such as over encapsulating, or compounding)?
No
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
Yes
If the answer is YES, indicate which items is is provided with this submission:
Modiﬁed research informed consent document that incorporates HIPAA requirements
CTRC Resources*
Does the research involve CTRC resources?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
Yes
Clinical Laboratory Services*
Will samples be collected by UPHS phlebotomy and/or analyzed by the hospital laboratory?
Yes
Anatomic Pathology Services*
Will tissue specimens (other than blood) be collected for clinical, diagnostic, or research purposes OR 
be processed through surgical pathology, cytopathology, neuropathology, or hematopathology?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
N/A
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?

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N/A
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes?
Yes
Primary Focus*
Epidemiological research
Protocol Interventions
Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
Survey instrument
x None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Department budget code
None
Multi-Center Research
Penn as lead
1. Is this a multi-center study where Penn is serving as the Lead Site or the Penn PI is serving as the 
Lead Investigator?
No
Management of Information for Multi-Center Research
Penn irb of record
2. Is this a multi-center study where the Penn IRB will be asked to serve as the IRB of Record for other 
external study sites?
No
Other Sites
No other sites

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Protocol
Abstract
Psoriatic arthritis (PsA) is a chronic inﬂammatory arthritis that can be associated with devastating 
outcomes including irreversible joint damage. The management of a patient with PsA is extremely 
challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to 
prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of 
this study speciﬁcally focus on responses to biologic therapy among patients with PsA and determining 
the optimal set of outcome measures for PsA trials.
Objectives
Overall objectives
This is a multi-center cross-sectional study aiming to obtain the data necessary to design a pragmatic 
trial in PsA including responses to biologic therapy among patients and determine the optimal set of 
outcome measures for PsA trials.
Primary outcome variable(s)
Aim 1. Determine responses to biologic therapy with among patients with PsA in real world setting. 
Hypotheses: a) The magnitude of response to TNFi will be lower in a heterogeneous PsA population 
(ACR20 40%) than in the homogenous RCT populations reported in the literature (ACR20 ~60%). 
Additionally, the magnitude of response, as deﬁned by multiple outcome measures including ACR20, 
will be lower in the subset of patients with active disease who would not be eligible for a typical RCT(3 
swollen joints) compared to patients who would be eligible for an RCT (3 swollen joints).  Rationale: 
The majority of patients with PsA are not represented in RCTs. To design high quality pragmatic trials 
with appropriate sample size estimates, response rates in real-life settings are needed.
Secondary outcome variable(s)
Aim 2. Deﬁne the optimal set of outcome measures for pragmatic trials with PsA. Hypothesis: A 
parsimonious set of instruments will be identiﬁed; these outcome measures will be responsive, non-
overlapping, and feasible for pragmatic trials. Rationale: Optimal outcome measures for pragmatic 
trials will be feasible, valid, and responsive across the diverse spectrum of patients with PsA. We will 
examine the responsiveness, minimal clinically important improvement (MCII) and discrimination of 
multiple PsA outcome measures. These results will inform selection of the primary and secondary 
outcomes for pragmatic trials and will also be relevant for traditional RCTs. Because subgroups of 
patients may respond differently, we will also examine the performance of the outcome measures within 
subgroups, including subphenotypes (e.g., axial disease, polyarticular, oligoarticular), demographics 
(e.g., sex), and common comorbidities (e.g., obesity and depression). These analyses will a) identify 
outcome measures suitable for pragmatic trials, b) determine if outcome measure selection should differ 
according to PsA subgroups and c) inform stratiﬁcation variables for pragmatic trials
Background
Psoriatic arthritis (PsA) is a chronic inﬂammatory arthritis associated with psoriasis, one of the most 
common autoimmune skin diseases affecting 2-3% of the population. Despite many advances in disease 
pathogenesis and therapeutics, approximately half of PsA patients continue to have active disease 
despite treatment. Therefore, it is imperative to test new treatment modalities including non-
pharmacologic therapies and novel management strategies. While randomized controlled trials (RCTs) 
can address efﬁcacy, or whether a drug can work, the homogenous population selected for inclusion in 
RCTs is not generalizable to the broader population of patients with PsA (a highly heterogeneous 
disease). By contrast, pragmatic trials test the effectiveness of management strategies in "real-world" 
clinical practice as opposed to the highly controlled settings in RCTs. Many important questions facing 
patients with PsA (e.g., comparative effectiveness) can be addressed with pragmatic trials. However, 
before this approach can be launched effectively, there is a fundamental need to identify appropriate 
outcome measures for PsA pragmatic trials. Currently the primary outcome in PsA RCTs, is the 
American College of Rheumatology 20% Response Criteria (ACR20), an outcome designed for 
rheumatoid arthritis, a substantially different inﬂammatory arthritis. Furthermore, the ACR criteria have 
intrinsic weaknesses that ultimately limit feasibility for a pragmatic trial, including the need for a blood 
test at two time points and underperformance in the most common PsA subpopulation (the half of 
patients with less than three swollen and tender joints at therapy initiation). The ultimate goal of this 
proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of 

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patients. Three objectives are envisioned: 1) Examine response in the heterogeneous population of 
patients that can be enrolled in pragmatic trials and compare those to the subset of patients who would 
be eligible for a traditional RCT; 2) Deﬁne the optimal set of outcomes for use in a pragmatic trial; and 
3) Examine how subgroups (e.g., sex, phenotypes, comorbidities) affect outcome measurement. We will 
address the aims in a prospective observational cohort study conducted within the multicenter Psoriatic 
Arthritis Research Collaborative (PARC). The four centers will also be the sites for the proposed 
pragmatic trial. At completion of the Aims, we will have all of the necessary components to initiate a 
pragmatic trial for PsA: outcomes will be selected, stratiﬁcation variables identiﬁed, sample size 
calculated, and data collection methods solidiﬁed. Additionally, we will identify expectations for 
treatment response in clinical practice, calculate minimal clinically important improvement, and 
examine how subgroups affect measurement of response. The results from the proposed studies will 
additionally inform outcome measures for traditional RCTs and clinical practice.
Study Design
Phase*
Not applicable
Design
a) prospective multicenter observational cohort study: phenotypes and patient characteristics will be 
compared among 4 psoriatic arthritis clinics in the United states
Study duration
The length of subject participation in the trial will be approximately 3 months. Estimated 2 years to 
enroll all subjects and complete study.
Resources necessary for human research protection
Describe research staff and justify that the staff are adequate in number and qualiﬁcations to conduct 
the research. Describe how you will ensure that all staff assisting with the research are adequately 
informed about the protocol and their research related duties. Please allow adequate time for the 
researchers to conduct and complete the research. Please conﬁrm that there are adequate facilities for 
the research.
The study team is composed of 5 investigators with diverse and complementary talents and experiences 
that are in line with the study goals. All investigators are members of the Group for Research and 
Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and all collaborate extensively with local 
psoriasis experts. Furthermore, all four centers have already been collecting data from patients in their 
PsA clinics, have published on many topics in PsA, and hold grants from a variety of sources. All four 
centers have outstanding scientiﬁc environments with supportive of division directors and track records 
for successful competition for NIH funding. The scientiﬁc environments at all four institutions are 
outstanding. All institutions have unmatched resources for clinical and translational research and all 
investigators have access to institutional Clinical and Translational Science Award (CTSA) resources. 
Additionally, all of the investigators have published studies in psoriatic arthritis and are active members 
within GRAPPA. Given that each center sees approximately 40-60 new patients with PsA each year, 
obtaining 55 new or return patients within the study period is feasible. Aligning data capture among our 
centers through completion of this study will allow for continued uniform data capture and 
collaboration. Furthermore, this model is sustainable and low cost as primary data is collected and 
stored within each institution primarily and data will be transferred into the PARC database as needed. 
Thus, the model could be modiﬁed by each institution to serve other ongoing studies and could be 
extended to other sites in the future.
Characteristics of the Study Population
Target population
Rheumatology clinic patients with active PsA switching to or adding a TNFi.
Subjects enrolled by Penn Researchers
55

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Subjects enrolled by Collaborating Researchers
220
Accrual
Patients seen by any rheumatology provider will be recruited at their new patient visit or return visit. 
Flyers about the study will be posted in examination rooms and rheumatology practitioners within the 
division will be educated about the study. The Penn Psoriatic Arthritis Clinic sees approximately 65-75 
patients with psoriatic arthritis per year.
Key inclusion criteria
-Age 18-89 -Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) 
(103) -Initiation of TNFi (etanercept, adalimumab, inﬂiximab, certolizumab, golimumab) (At the time 
of the submission of this grant, TNFi biosimilars have been approved by the FDA but are not available 
on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for 
participation. Patients may have been on the medication in the past but must have had greater than 2 
months off the medication.Patients may be taking other traditional DMARDs. A washout period is not 
required.)
Key exclusion criteria
-Unable to give informed consent -Out of the age range -Switching therapies for skin psoriasis in the 
setting of well controlled joint and enthesis symptoms. -Patients with only active PsA
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Populations vulnerable to undue inﬂuence or coercion
Although not directly targeted, mentally disabled persons, economically or educationally disadvantaged 
persons, and/or employees or students of the University of Pennsylvania will not be denied enrollment 
and any special protections and/or additional safeguards will be undertaken in order to protect the rights 
and welfare of these subjects from coercion or undue inﬂuence as appropriate.
Subject recruitment
Patients seen by any rheumatology provider may be recruited by the study team (as listed in HS-ERA) 
at their new patient visit or return visit. Flyers about the study will be posted in examination rooms and 
rheumatology practitioners within the division will be educated about the study.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes

Page 12 of 17
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Participants will receive $30 at the completion of the second visit for their participation in the study. 
Participants will be compensated by Clincard. Greenphire/Clincard have agreed to waive Social 
Security number collection for this study.
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
Patients may be recruited before or after a new patient visit or return visit. In the case that the visit 
encounter is completed before enrollment, only the additional information not collected for clinical 
purposes will be collected. In other words, most of this information is collected in a routine clinic 
encounter. The information collected during that encounter will be used to complete as much of the 
CRF as possible and then the additional elements from the CRF will be completed by the research 
coordinator or site PI following that visit using information from the visit notes.  After informed 
consent is obtained by a member of the study team listed on HS-ERA, a detailed history about the 
patient's arthritis will be taken and a complete examination will be performed by the rheumatologist. 
Patients will complete a set of Patient Reported Outcome (PRO) surveys electronically or on paper. 
Participants may also choose to have the survey link emailed and complete the PRO's within the 2 
weeks following the baseline enrollment visit. Results of laboratory tests and radiography obtained for 
clinical purposes will be recorded. We will record the therapeutic regimen planned at the end of the 
clinical encounter. This data will be collected by the rheumatologist and the research coordinator at 
each site.  Patients will also undergo a blood draw by venipuncture at the outpatient lab. Approximately 
40 mL (4 tubes) of blood will be drawn at each visit. No more than 50 mL will be drawn at each visit. 
Clinical labs may also be drawn at this time. The study team will pick up the blood, process it, and store 
it onsite at UPenn/UPHS. The research blood draw will be ordered in EPIC and charged to the study but 
all other items in this study are considered clinical care and will be charged to insurers/subjects as 
usual.  At a follow up visit approximately 3 months from the initial study visit, a thinned version of the 
CRF will be used to update the information collected from the participant and record any changes and 
response to therapy. . The participant will also ﬁll out a different version of patient outcome 
measurements, have a complete examination performed by a rheumatologist, and undergo a blood draw 
again. A link to the PRO surveys will be emailed out 2 weeks prior to the scheduled follow-up visit and 
will be available until 2 weeks after the visit. Participants can also choose to complete the PROs at the 
visit on paper or electronically. The blood and information collected throughout this study will be used 
to build a repository for future research projects. The de-identiﬁed information stored in the redcap will 
available to the study teams at each of the sites involved in this study and to those PIs for future 
research. Researchers not involved in this study will not be permitted to request or use data or samples 
from this study. Blood samples will be processed and stored at individual sites. Blood samples may be 
shipped to a central location for further testing but will not be made available to outside researchers. 
Further testing will be focused on bio-markers of treatment response and disease progression. 
Participants may retract permission and ask that their samples be destroyed.
The following documents are currently attached to this item:
There are no documents attached for this item.

Page 13 of 17
Deception
Does your project use deception?
No
International Research
Are you conducting research outside of the United States?
No
Analysis Plan
We will report demographics and disease characteristics of the patients by center. Similarly, we will 
describe the PsA phenotypes of patients enrolled at each site, patients previous therapies, and new 
therapy prescribed stratiﬁed by PsA phenotype. The chi-squared test will be used to test the difference 
in prevalence of each disease phenotype by center. A one-way ANOVA test (or Kruskal Wallis, the non-
parametric equivalent) will be used to determine whether there is a signiﬁcant difference between 
centers in mean disease severity (DAS66/68 score, HAQ score, RAPID3 score) and duration of 
psoriasis. With 20 patients in each group and an effect size 1.1 (assuming difference in min and max 
mean scores of 5.5 and standard deviation of 5), we will have 82% power to detect a signiﬁcant 
difference (=0.05). While this is a modest estimation of standard deviation for some of the measures 
listed, we believe the sample size will be adequate to provide important initial observations in this 
proof-of-concept study. Furthermore, understanding of the basic epidemiology of psoriatic arthritis 
phenotypes within the four clinics will provide important observations for future study planning.
The following documents are currently attached to this item:
There are no documents attached for this item.
Data conﬁdentiality
x Paper-based records will be kept in a secure location and only be accessible to personnel involved 
in the study.
x Computer-based ﬁles will only be made available to personnel involved in the study through the 
use of access privileges and passwords.
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and conﬁdentiality of identiﬁable information.
x Wherever feasible, identiﬁers will be removed from study-related information.
A Certiﬁcate of Conﬁdentiality will be obtained, because the research could place the subject at 
risk of criminal or civil liability or cause damage to the subject's ﬁnancial standing, 
employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the 
subject and the study would be the consent document and the primary risk is a breach of 
conﬁdentiality. (This is not an option for FDA-regulated research.)
Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identiﬁcation of subjects.
Subject Conﬁdentiality
All four institutions use the Epic electronic medical record system and have existing REDCap databases 
(see Computer Resources for more information on REDCap). For the purpose of this study and use in 
future studies, we will build a PARC Core REDCap Database. All four institutions will have access to 
this Core REDCap Database with designated data use agreements. The PARC Core REDCap Database 
will then be populated from each of our existing institutional RedCap databases. Personal identiﬁers 
(name, medical record number) will not be stored as a part of this dataset. Instead, personal identiﬁers 
will remain within each individual institution and only de-identiﬁed data placed in the Core REDCap 
database. To ensure the protection of the subjects and data integrity, we will maintain the highest 
security settings for the Core REDCap Database. Each user will have a speciﬁc user-ID and password 
and will access only de-identiﬁed data. Personal identiﬁers from each site will only be visible to 
providers and study team at that site.For our site, any data involving personal identiﬁers or contact 

Page 14 of 17
information will be kept on a UPHS maintained server and accessed via password protected computers. 
This REDCap Database will include elements of dates. A data use agreement was executed between the 
institutions involved in this study for the PARC study (819801) and an appendix has been added to that 
agreement in order to include the speciﬁcs of this study.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record?
No
Subject Privacy
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas conﬁdentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly 
disciplines (e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
Patients will be seen in private clinic rooms with only the physician and possibly the coordinators, both 
of which are HIPAA trained and will not discuss the patient outside of clinic areas. Patients will be 
recruited through word of mouth, by other rheumatologists mentioning the study, and also by patients 
themselves seeing the ﬂyers. All participation is voluntary. All questionnaires being presented to the 
patients are well-accepted methods of data collection, and the answers to the questionnaires will be 
discussed with the patient in the private clinic room should any questions arise. Participants will be 
asked to provide their phone numbers and/or email addresses for study follow-up. This contact 
information will not be shared outside of the study team or used for purposes outside this study.
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
Yes, data will included in a RedCap database and shared with study teams at NYU, Cleveland Clinic 
and University of Utah. Personal identiﬁers and contact information will not be included in this 
database. A data use agreement has been set up between these institutions.
Data Protection*
x Name
Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None

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Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Tissue Specimens Obtained as Part of Research*
Are Tissue Specimens being obtained for research?
Yes
Tissue Specimens - Collected during regular care*
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)?
Yes
Tissue Specimens - otherwise discarded*
Would specimens otherwise be discarded?
Yes
Tissue Specimens - publicly available*
Will tissue specimens be publicly available?
No
Tissue Specimens - Collected as part of research protocol*
Will tissue specimens be collected as part of the research protocol?
Yes
Tissue Specimens - Banking of blood, tissue etc. for future use*
Does research involve banking of blood, tissue, etc. for future use?
Yes
Genetic testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 
of genetic counseling. Describe how subject conﬁdentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable."
This study may include testing of bio-markers to better understand the phenotypes of psoriatic arthritis 
as well as treatment response and disease progression. This testing is exploratory and the results will 
not be returned to participants or recorded in medical records.
Consent
1. Consent Process
Overview
Patients seen by any rheumatology provider may be recruited at their new patient visit or return visit. 
Flyers about the study will be posted in examination rooms and rheumatology practitioners within the 
division will be educated about the study. Informed consent may be obtained by the PI or study 
personnel listed in HS-ERA.  Study personnel will discuss the goals of the study and the information 
that will be collected from the medical record and clinical notes. They will also discuss the kinds of 
questionnaires/surveys that the participant will be asked to complete and any risks involved in the study 
including loss of conﬁdentiality. Since this study involves de-identiﬁed data being shared with study 
teams and stored for future research, this will also be discussed with participants. This consent process 
will also cover how and why blood will be collected, tested, and stored and the risks of this procedure.
Children and Adolescents
N/A

Page 16 of 17
Adult Subjects Not Competent to Give Consent
Adult subjects not competent to give consent will not be consented.
2. Waiver of Consent
Waiver or Alteration of Informed Consent*
No Waiver Requested
Minimal Risk*
Impact on Subject Rights and Welfare*
Waiver Essential to Research*
Additional Information to Subjects
Written Statement of Research*
No
If no written statement will be provided, please provide justiﬁciation
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt
Potential Study Risks
There is a minimal risk of loss of conﬁdentiality. There are also risks involved in collecting blood via 
venipunture including local pain, bruising, bleeding, fainting, blood clot formation, and in rare 
instances, an infection at the blood draw site. This study does include blood that may be used in bio-
marker studies but these tests are exploratory and the results will not be returned to participants. 
Because this study is framed around clinical procedures, incidental ﬁndings are not considered a risk as 
their discovery would be considered part of clinical care.
Potential Study Beneﬁts
There are no individual beneﬁts to be obtained through participating in the study. However, the beneﬁt 
to our understanding of psoriatic arthritis and how to better treat psoriatic arthritis will be signiﬁcant.
Alternatives to Participation (optional)
The alternative is to not participate.
Data and Safety Monitoring
Principal Investigators will monitor the study at each individual site.
The following documents are currently attached to this item:
There are no documents attached for this item.
Risk / Beneﬁt Assessment
Minimal Risk
General Attachments
The following documents are currently attached to this item:
Cover Letter (pb_irbcoverletter_8_14_2019.doc)

Page 17 of 17
Additional forms (citi_deeluo.pdf)