Clinical trial NCT04093531
Conditions: Primary Sjögren Syndrome
Keywords: primary sjogren syndrome PSS SjS Sjogren Ustekinumab SS
Sponsor: University of Rochester
Start date: 2020-01-15; Completion date: 2022-05-11
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will make a preliminary determination of the safety of ustekinumab in patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures of inflammation (biomarkers).

Detailed description:
This is a single-center, open label, pilot trial of ustekinumab in patients with Primary Sjögren's Syndrome (PSS). Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.

Arms: arm 1: All subjects will receive an intravenous loading dose of 6 mg/kg at their baseline visit. 650mg acetaminophen and 60mg allegra will be given as premedication to the infusion. All patients will receive 90mg ustekinumab by a subcutaneous injection at all subsequent dosing visits. Subcutaneous injections do not require any premedication. Drug will be administered by qualified personnel.
Interventions: intervention 1: Ustekinumab
Intervention descriptions: intervention 1: Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.

Protocol documents:
Prot_SAP_000.pdf: 
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NCT04093531 
Pilot Trial of Ustekinumab for Primary Sjögren’s Syndrome  
Principal Investigator: Ummara Shah, M.D. 
Co Sub-Investigator: Jennifer Anolik, M.D., PhD.  
Co Sub-Investigator: Christopher Ritchlin, M.D.  
Sponsor: University of Rochester Medical Center 
Funded by: Janssen Scientific Affairs Inc. 
Definitions: 
Company: Janssen Scientific Affairs Inc. 
Institution: University of Rochester Medical Center 
1. PURPOSE OF THE STUDY AND BACKGROUND 
1.1 Purpose 
Objectives: This pilot study will make a preliminary determination of the safety of ustekinumab 
in patients with Primary Sjogren’s Syndrome (PSS) and assess the response of systemic measures 
of inflammation (biomarkers). If this study is successful we would anticipate applying for a 
moderate size phase IIa study where subjects would be randomized to ustekinumab or placebo. 
Primary clinical objective: To examine the safety of ustekinumab in patients with PSS. 
Secondary clinical objective: To assess the effect of ustekinumab on the subjective and objective 
clinical manifestations of PSS. 
Primary Mechanistic objective: To determine whether the standard dosing schedule for 
ustekinumab lowers serum biomarkers of inflammation in patients with PSS.  
1.2 Background 
Sjogren’s syndrome (SS) is a chronic systemic autoimmune disease, for which no treatment is 
available. For this trial, we propose to study the safety and clinical efficacy of ustekinumab, a 
human monoclonal antibody that works by inhibiting the p40 subunit of the proteins IL-12 and 
IL-23. Ustekinumab has been FDA approved for treatment of moderate–to-severe plaque 
psoriasis. Similar to psoriasis, T cells are central effectors in SS, as demonstrated by the T cell 
predominance of the salivary glands lymphocytic infiltrates, with a large predominance of CD4+ 
T cells [1]. Pathophysiologic models emphasize an “autoimmune epithelitis” [2], where the initial 
injury triggers a cytokine cascade leading to development of SS at the site of salivary epithelial 
cell. Recent studies indicate that IL-17 plays a critical role in epithelial defense, while IL-22 
promotes keratinocyte proliferation and secretion of host defense protein [3]. Increased plasma 
levels of IL-6, IL-12, IL-23, and IL-17 have been observed in SS. Furthermore, cells staining for 
IL-6, IL-23, and IL-17 as well as IL12 and IFNγ are present in  salivary glands from SS patients 
[4] and increased levels of IL17, IL23 and their receptors are expressed on these cells [5]. Most 
importantly, ustekinumab has a very favorable safety profile, making it an attractive therapeutic 
agent for a patient population that is “starving” for an effective treatment. 


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2. STUDY DESIGN 
 
2.1. Overview 
This is a single-center, open label, pilot trial of ustekinumab in patients with Primary Sjögren’s 
Syndrome (PSS). Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of 
ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 
20. Subjects will be followed for 24 weeks. 
 
2.2. Endpoints 
• 
The primary endpoint is a well-established, patient reported questionnaire for use in PSS, 
ESSPRI [6]. The reason we chose a patient-reported outcome is multifactorial. Prior study 
with rituximab in PSS has demonstrated modest improvements at week 26 in patient-
reported symptoms of fatigue and oral dryness, with no significant improvement in the 
objective measures of lacrimal and salivary gland function [7]. As most patients with PSS 
report that dryness and fatigue are the two most bothersome health issues, we feel that 
focusing on this aspect of the illness will be most meaningful from a patient perspective. 
• 
Secondary endpoints: Change between day 0 and week 24 in the following: 
 Subjective efficacy 
(1) Short Form-36 questionnaire (SF-36) 
(2) VAS global assessments of symptoms of oral and eye dryness 
(3) VAS global assessment of fatigue 
(4) VAS global assessment of joint pain 
 Objective efficacy  
(1) Unstimulated and stimulated salivary flow  
(2) European League Against Rheumatism (EULAR) Sjögren’s  
Syndrome Disease Activity Index (ESSDAI) 
 Mechanistic studies 
(1) Serum levels of TNFα, IL-6, IL17, IL17A, IL17F, IL22, IL12, IL23, 
BAFF (baseline, 12, 24 weeks) 
(2) B and T cell subsets analysis baseline, 12, 24 weeks 
(3) Peripheral blood interferon signature (baseline, 12, 24 weeks) 
 SS Disease Activity Labs 
(1) Autoantibodies:  Anti-Ro (screening), ANA, anti-La, RF (baseline, 
12, 24 weeks) 
(2) Inflammatory markers: CRP, ESR (baseline, 12, 24 weeks) 
(3) Markers of immunological activation : IgG, C3, and C4 (baseline, 
12, 24 weeks)  
 Safety  
(1) Adverse events; serious adverse events 
(2) Total infections; serious infections 
(3) CBC with differential and chemistry panel at baseline, 4, 12, 20 and 
24 weeks 
(4) SF-36. 
(5) Stimulated and unstimulated whole salivary flow 


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(6) ESSDAI 
(7) VAS global assessments of symptoms of oral and eye dryness 
(8) VAS global assessment of fatigue 
(9) VAS global assessment of joint pain 
 
2.3. Rationale for Study Design 
Nothing is known about the potential benefits of ustekinumab therapy for PSS, although a 
scientific rationale does exist for hypothesizing that this drug may improve the signs and 
symptoms of this disease. As ustekinumab has not been previously tested in PSS population, we 
decided that a pilot study to assess safety and efficacy in a small group of subjects is the most 
appropriate design. The open label design makes it difficult to properly assess efficacy but can 
provide the necessary data and framework for a larger phase III randomized, double blind clinical 
trial.  The objective of the study is to assess efficacy and safety of ustekinumab in patients with 
PSS. Each patient will be his/her own control, and we will look for the difference in the outcomes 
listed between baseline and 24 week end-point.  
 
2.4. Rationale for Dosage 
The efficacy and safety of ustekinumab (UST) in the treatment of lupus was evaluated in a global 
Phase 2, randomized, placebo-controlled trial in 102 adults with seropositive SLE by Systemic 
Lupus International Collaborating Clinics (SLICC) criteria and active disease despite ongoing 
standard of care therapy (steroid, antimalarial and/or immunosuppressive therapies) 
(https://www.jnj.com/media-center/press-releases/stelara-ustekinumab-shows-positive-
resultsin-treatment-of-systemic-lupus-erythematosus-in-phase-2-trial). 
Patients 
were 
randomized (3:2) to receive intravenous (IV) STELARA® 6 mg/kg or placebo (PBO) at week 0, 
followed by subcutaneous (SC) injections of STELARA® 90 mg or placebo every eight weeks, 
both in addition to standard of care therapy for 24 weeks. At week 24, patients in the placebo 
arm crossed over to active study agent.  
Systemic lupus erythematosus and PSS have very similar cytokine profiles, and there is a 
significant overlap in the cytokine disturbances. Therefore, it is mechanistically reasonable to 
use a similar dose for PSS. An infusion loading dose of 6mg/kg of ustekinumab will be 
administered, followed by 90mg subcutaneous injections of ustekinumab approximately every 4 
to 8 weeks. We chose this dose based on recent evidence of ustekinumab efficacy in SLE.  
 
2.5. Rationale for Mechanistic Samples 
The purpose of the mechanistic studies is to examine the effects of ustekinumab therapy on the 
mechanisms of disease in PSS and on immunocompetence. The specific aims are to determine if 
ustekinumab treatment produces changes in systemic immune function, as evidenced by serum 
levels of acute phase reactants, serum levels of autoantibodies (including but not limited to 
antiSSA(Ro) and anti-SSB(La) antibodies, and rheumatoid factor (RF), serum level of cytokines 
and chemokines, peripheral blood T and B cell subsets, and the interferon signature in peripheral 
blood. 
Although the pathogenesis of Primary Sjogren’s Syndrome remains unclear, the disease has 
traditionally been believed to be T cell mediated. Histology suggests that in SS T cells tend to 
dominate the glandular lesions early on while B cells tend to dominate the late phase of the 
disease  [11]. However, recent evidence indicates a major contribution of B cells [12]. Such 
abnormalities include B-cell hyperactivity manifested through hypergammaglobulinemia and a 


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constellation of autoantibodies including both organ-specific antibodies and systemic 
autoantibodies (anti-nuclear antibodies, anti-Ro and anti-La and rheumatoid factor) [13]. 
Interestingly, these autoantibodies may be present before obvious salivary dysfunction develops 
suggesting that they are not secondary to the tissue damage.  
In this context, B cell activating factor belonging to the tumor necrosis factor (TNF) family 
(BAFF) was found to be strikingly associated with SS [14]. In mice, BAFF overexpression is 
responsible for B cell compartment expansion and autoimmune manifestations such as lupus-like 
disease and SS which progress with age [15]. BAFF overexpression is associated with 
autoantibody production in primary SS. Recombinant soluble BAFF co-stimulates B cells in vitro 
to proliferate and secrete Ig [16] and elevated levels of BAFF were found in sera from patients 
with SLE and primary SS [17, 18]. In primary SS, BAFF levels were higher in patients with 
antiSSA or anti-SSB Abs compared to patients without detectable levels of these autoantibodies 
[19]. One interesting feature of SS autoimmunity in both humans and animal models of SS is the 
high levels of IFN, both IFN-α/β and IFN-γ [11, 20].  SS, like systemic lupus erythematosus 
(SLE) [21] has been designated an autoimmune disease characterized by an “IFN-signature.” 
models, based on the elevated levels of plasma IFNs in SS patients and the reported activation of 
multiple IRGs/ISGs seen in microarray studies [22]. 
The cytokine imbalance in SS has been long described. The peripheral blood is characterized by 
overexpression of the interferon regulated genes [23], high immunoglobulin levels and the 
presence of autoantibodies indicating concomitant activation of the innate and adaptive immune 
system. In the exocrine glands pro- inflammatory cytokines, such as Interferon (IFN)α and γ, 
tumor necrosis factor (TNF) α, interleukin (IL-)12 and IL-23 along with other cytokines 
important in T and B cell activation and autoantibody production, such as IL-6 and B cell 
activating factor (BAFF), are overexpressed [24].  Interleukin-12 (IL-12) is a heterodimeric 
cytokine produced predominantly by activated monocytes and dendritic cells. It enhances 
proliferation and cytolytic activity of natural killer (NK) and T cells, and stimulates their IFN-γ 
production [25]. An age-dependent increase in anti-SSB/La antibodies was observed in IL-
12transgenic mice and was accompanied by an increase in antinuclear antibodies [26].  
3. CHARACTERISTICS OF THE RESEARCH POPULATION 
 
3.1. Subject Characteristics 
Patients fulfilling the 2016 ACR EULAR classification criteria for PSS (see below) who are 
stable in terms of their PSS and are otherwise in good health. Systemic manifestations of the 
disease (fatigue, joint pain, peripheral neuropathy, interstitial lung disease, leukocytoclastic 
vasculitis, renal tubular acidosis, significant parotid swelling) will be documented, but will not 
be a requirement for eligibility.  
a) Number of Subjects: The first 15 subjects who meet all eligibility criteria will be enrolled 
into the treatment 
b) Gender and Age of Subjects:  This study will enroll adults, male and female, aged 18-75 
years old.  
c) Racial and Ethnic Origin: Racial and ethnic origin of subjects will be monitored to reflect 
the diversity of our community. Because of the epidemiology of PSS, we expect more women 
than men and more whites (non-Hispanic) in that population. However, no subjects will be 
excluded based on race or ethnic origin.  


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d) Vulnerable Subjects: Vulnerable subjects will not be targeted. The stipend is appropriate to 
the level of inconvenience and pain of the procedure and therefore should not be coercive. 
Subjects will be assured that they are free to not participate or to withdraw at any time, 
without risking loss of present or future care that they would otherwise receive. 
 
3.2. Inclusion and Exclusion Criteria 
Inclusion: A subject who has met all of the following criteria is eligible for participation in the study: 
1) Has provided written informed consent 
2) Between the ages of 18-75 years (inclusive) 
3) Body weight ≥ 40 kg 
4) Meets the 2016 ACR EULAR criteria (score >4) 
a. 3 points- Labial salivary gland with focal lymphocytic sialadenitis and focus score of >1 
foci/4 mm2‡ 
b. 3 Points- Anti-SSA/Ro positive  
c. 1 Point- Ocular Staining Score >5 in at least 1 eye 
d. 1 Point- Schirmer’s test <5 mm/5 minutes in at least 1 eye 
e. 1 Point- Unstimulated whole saliva flow rate <0.1 ml/minute 
5) If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 10 mg/day and stable for at 
least 4 weeks prior to baseline visit 
6) If taking hydroxychloroquine, the dose must be stable for at least 12 weeks prior to baseline.  
7) If taking a cholinergic stimulant (e.g. pilocarpine, cevimeline), the dose must be stable for at least 
4 weeks prior to baseline. 
8) If a female of childbearing potential, must agree to practice two highly effective forms of 
contraception during the study (one of which must be a barrier method) and able to continue 
contraception for 20 weeks after her last dose of study agent. 
9) If a male of reproductive potential, must agree to practice two highly effective forms of 
contraception during the study (one of which must be a barrier method) and be able to continue 
contraception for 20 weeks after his last dose of study agent. Subject must also agree not to donate 
sperm up to 20 weeks after his last dose of study drug.  
Exclusion: A subject who meets any of the following criteria is disqualified from participation in the 
study:  
1) Has a chronic or persistent infection that might be worsened by immunosuppressive treatment (e.g., 
HIV, hepatitis B, hepatitis C, or tuberculosis). 
2) History of untreated TB or positive QuantiFERON TB-Gold during screening period.  If a subject 
has previously received an adequate course of therapy for either latent (9 months of isoniazid in a 
locale where rates of primary multi-drug resistant TB infection are <5%) or active TB infection, a 
QuantiFERON TB-Gold test need not be obtained, but a chest radiograph or other appropriate 
image must still be obtained if not done so within the prior 3 months.  
3) History of recurrent significant infections or occurrence of a serious local infection (e.g., cellulitis, 
abscess) or systemic infection (e.g., pneumonia, septicemia) within twelve weeks prior to Day 0. 
4) Active symptomatic infection within two weeks prior to Day 0. 
5) Receipt of live vaccine within four weeks prior to Day 0. 
6) History or presence of primary or secondary immunodeficiency. 
7) History of any life-threatening allergic reactions to pilocarpine, latex, or any components of 
ustekinumab. Pilocarpine will be used to stimulate salivary flow in order to assess flow rate.  
Latex is a component in the needle cover for the pre-filled syringes containing the study drug.  


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8) Is currently pregnant or nursing. 
9) Concurrent use of anticholinergic agents, such as tricyclic antidepressants (i.e. amitriptyline, 
nortriptyline, imipramine), first generation antihistamines (including diphenhydramine and 
hydroxyzine), phenothiazines, antiparkinsonian drugs, anti-asthmatic drugs (i.e. ipratroprium), or 
gastrointestinal (GI) medications that cause xerostomia in more than 10% of patients. 
10) Treatment with any of the following within the defined period prior to the screening and Day 0 
visits: 
a. 12 months for rituximab 
b. 24 weeks for cyclophosphamide 
c. 8 weeks for azathioprine, cyclosporine, methotrexate, and mycophenolate mofetil 
d. 4 weeks for intravenous immunoglobulin 
e. 4 weeks for etanercept 
f. 8 weeks for adalimumab 
g. 12 weeks for infliximab 
h. 8 weeks Golimumab  
i. 
8weeks Certolizumab pegol  
j. 
16 weeks Abatacept  
k. 4 weeks Tocilizumab SQ   
l. 
16 weeks Tocilizumab IV  
m. 4 weeks Tofacitinib and Tofacitinib XR  
11) Prednisone (or equivalent corticosteroid) > 10 mg/day. 
12) A definite diagnosis of RA, SLE, systemic sclerosis, or dermatomyositis. 
13) A history of alcohol or substance abuse within 5 years of baseline. 
14) A history of head and neck radiation therapy, sarcoidosis, or graft-versus-host disease. 
15) A history of malignancy, except for a resected basal or major squamous cell carcinoma, cervical 
dysplasia, or in situ cervical cancer Grade I, within the last five years. 
16) Abnormal laboratory results for the following parameters at the baseline visit: 
a. Absolute neutrophil count (ANC): < 1500/mm3 
b. Platelets: < 100,000/mm3  
c. Hemoglobin: < 9 grams (g)/deciliter (dL) 
d. Serum creatinine: ≥ 2.0 mg/dL 
e. AST: > 1.5x upper limit of normal 
f. ALT: > 1.5x upper limit of normal.  
17) A psychiatric disorder rendering the subject incapable of providing informed consent. 
18) Plans for foreign travel to countries other than Canada or Western Europe within the treatment 
period. 
19) Inability or unwillingness to follow the protocol 
20) Any condition or treatment that, in the opinion of the investigator, places the subject at an 
unacceptable risk as a participant in the trial. 
 
3.3. Discussion of Subject Population 
The criteria were selected, firstly, in order to minimize the risks and account for the subject’s 
safety. The criteria was also designed to select a subject population characteristic of PSS patients 
while eliminating as many confounding variables as able.  


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4. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT 
 
4.1. Method Of Subject Identification And Recruitment 
The investigators have a well-defined population of PSS patients in a repository (RSRB# 35516, 
STUDY 0276) who have consented to contact about future research. Subjects will be first 
recruited from the repository. Subjects will also be recruited by the medical staff at surrounding 
Allergy, Immunology and Rheumatology clinics. This study may also identify potential subjects 
for recruitment using the CTSI Research Participant Registry, RSRB#42818. 
 
4.2. Process of Consent 
Consent will be obtained by one of the investigators and/or study coordinators. A verbal 
consent will be obtained over the phone in order for potential subjects to hold salivary stimulant 
or tear production medications they might be taking as well as lubricating eye drops prior to 
screening. Subjects will also be asked via the verbal script to not wear eye make-up to the 
screening visit. Full informed consent will be obtained at the screening visit, prior to any study 
procedures. Subjects will be asked to sign a separate consent form for HIV testing. Female 
partners of male study subjects who become pregnant during the study or during 20 weeks after 
their partner’s last study medication dose will be asked to sign a separate consent form to 
remain in contact, collect information regarding the pregnancy and to contact the childbirth 
doctor(s). 
The study will be described orally and the subject will be given the opportunity to read the 
consent form and ask questions. The subject may also communicate with the study team 
member by writing back and forth. Those wishing to consider the study further or discuss it 
with their family members will be given a copy for review either through mail, email, or in 
person. They will also be informed that they are not required to participate in the study in order 
to receive care or treatment for their condition and that they may terminate their consent at any 
point. The signed consent form will be stored in a secure location.  
5. METHODS AND STUDY PROCEDURES 
Schedule of Activities 
Procedures 
Screening 
Baseline 
Week 
4 
Week 
12 
Week 
20 
Week  
24/  
ET 
Unscheduled 
Informed Consent 
x 
  
  
  
  
  
  
Eligibility / Inclusion/Exclusion 
x 
x 
  
  
  
  
  
Medical History (complete) 
x 
  
  
  
  
  
  
Medical History (Interval) 
  
x 
x 
x 
x 
x 
x 
Concomitant Medication 
x 
x 
x 
x 
x 
x 
x 
Vital Signs, including weight 
x 
x 
x 
x 
x 
x 
x 
Complete Physical Exam 
x 
  
  
  
  
  
  
Targeted Physical Exam 
  
x 
x 
x 
x 
x 
x 
Schirmer’s Test* 
x 
 
 
 
 
 
 
AE Assessment 
x 
x 
x 
x 
x 
x 
x 
Salivary Flow (unstimulated) 
 x 
x 
  
  
  
x 
  


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Salivary Flow (stimulated) 
 
x 
 
 
 
x 
 
Efficacy Assessments ( ESSPRI, 
SF36, VAS global) 
  
x 
  
  
  
x 
  
ESSDAI 
 
x 
 
 
 
x 
x 
UA reflex to micro (ESSDAI) 
  
x 
  
  
  
x 
x  
CBC with Diff & Chem Panel 
x 
x 
x 
x 
x 
x 
x 
ANA, Anti-La (SSB), Anti-Ro (SSA) 
& RF 
 x 
x 
  
  
  
x 
  
CRP, ESR, C3, C4, IgG 
  
x 
  
 x 
  
x 
  
HIV, Hep B & C 
x 
  
  
  
  
  
  
Serum Pregnancy Test 
x 
  
  
  
  
  
  
QuantiFERON TB-Gold 
x 
 
 
 
 
 
 
Mechanistic Samples (collection) 
  
x 
 
x 
 
x 
  
POCT Pregnancy Test (UA) 
  
x 
x 
x 
x 
  
  
Drug Administration 
  
x 
x 
x 
x 
  
  
Total Volume of Blood Drawn per 
visit 
28mL 
120mL 
9mL 
120mL 
9mL 
120mL 
9mL 
*Schirmer’s Test will only be done on subjects who do not meet the unstimulated whole saliva flow rate criteria 
value at screening.  
┼ Female subjects of childbearing potential will also receive a phone call 20 weeks after their last dose of IP to 
see if they have become pregnant.  
 
5.1. Treatment Dosage and Administration 
All subjects will receive an intravenous loading dose of 6 mg/kg at their baseline visit. 650mg 
acetaminophen and 60mg allegra will be given as premedication 30-60 minutes prior to the 
infusion. Subjects with a history of an allergic reaction to either allegra or acetaminophen will be 
given an equivalent substitute. The intravenous loading dose and premedication will be 
administered to the subject by qualified personnel at the clinical research center over a period of 
at least 1 hour. Subjects will be asked to wait an additional hour at the study site to monitor for 
adverse reactions. All patients will receive 90mg ustekinumab by a subcutaneous injection at all 
subsequent dosing visits. Subcutaneous injections do not require any premedication. Drug will 
be administered by qualified personnel. Subjects will be asked to wait for 15 minutes after the 
subcutaneous injection to monitor for adverse reactions.   
5.2. Efficacy 
Assessments 
Patient Questionnaires  
• 
European League Against Rheumatism (EULAR) Sjögren’s Syndrome Patient 
Reported Index (ESSPRI) 
• 
Short Form-36 questionnaire (SF-36) 
• 
VAS global assessments of symptoms of oral and eye dryness 
• 
VAS global assessment of fatigue 
• 
VAS global assessment of joint pain 
Coordinator or PI administered assessments 
• 
Unstimulated and stimulated salivary flow o Salivary flow rate will be measured 
using the whole saliva technique. The subject will be asked to not eat or drink for 1 
hour prior to the assessment and to not take medications to increase salivary flow for 


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48 hours prior to the visit. All subjects will have their unstimulated whole salivary 
flow measured for 15 minutes followed by administration of a single 5mg dose of 
Pilocarpine. The 15 minute measurement of the stimulated salivary flow rate will 
begin one hour after administering the Pilocarpine. The weight of the samples will 
be recorded and used to calculate volume. An average of each sample will be 
calculated in order to determine flow rate.    
• 
Schirmer’s Test 
o A Schirmer’s thin filter paper strip will be inserted in the lower fornix of the 
eye and remain there for five minutes. When the strip is removed it will be 
read to determine the length of the strip that is wet (in mm), which is 
proportional to the quantity of tears produced.  
• 
European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease 
Activity Index (ESSDAI) 
SS Disease Activity Labs 
• 
Serum levels of autoantibodies, inflammation, and immune activations.  
o Autoantibodies:  ANA, anti-Ro, anti-La, RF o Inflammatory 
markers: CRP, ESR  
o Markers of immunological activation : IgG, C3, and C4  
Mechanistic Studies 
• 
Serum levels of TNFα, IL-6, IL17, IL17A, IL17F, IL22, IL12, IL23, BAFF 
• 
B and T cell subsets analysis 
• 
Peripheral blood interferon signature 
 
5.3. Safety Assessments 
• 
Adverse events; serious adverse events 
• 
Total infections including serious and opportunistic infections 
• 
CBC with differential and chemistry panel  
• 
Serum pregnancy test at screening, for applicable subjects.  Urine pregnancy test 
before drug administration on days of dosing, for applicable subjects. 20 week 
follow-up phone call for applicable subjects. 
• 
Physical exam with vital signs– complete physical exam at screening.  Targeted 
physical exams at all other visits. 
 
5.4. Data & Specimen Banking for Future Research Use 
The subjects will be given the option of allowing their blood samples to be stored frozen in our 
secure lab for future research, if there is remaining blood after the tests for this study. These 
samples will only be accessed by members of the research staff. If the subjects agree, we will 
preserve the blood samples and use them in future studies. The future testing will not include 
genetic studies. 
Repository 
The Allergy, Immunology and Rheumatology Division has a subject repository protocol (RSRB 
#35516, STUDY 0267). This protocol stores all research data obtained so that it may be analyzed 
in conjunction with other studies.  It also allows us to collect the names and private health 
information (PHI) of people who have taken part in our research studies and who are interested 
in participating in future studies. Subjects will be asked whether they are interested in being 
contacted for future studies and those that agree will have their PHI entered into our repository 


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database.  This repository protocol maintains samples from subjects who agree to store for future 
research any samples remaining after research assays are completed. 
 
5.5. Costs to the Subject 
There will be no cost to the subject. Some standard of care labs may be drawn at the same time 
as research blood for subject convenience. These standard of care labs will charged to third party 
providers. This will be discussed with the subject prior to drawing blood and the subject will 
have the option to decline this courtesy.  
 
5.6. Payment for Participation 
Subjects will be paid in petty cash at the end of each completed visit. Subjects may also be given 
the option to be paid by check. They will be paid $75 for each completed scheduled visit. They 
will also be given a parking pass for each visit. Subjects will not be paid for an unscheduled visit.  
 
5.7. Return of Individual Research Results 
Subjects with autoimmune diseases have lab tests performed regularly to monitor their disease. 
Clinical labs results conducted as part of the research study or standard of care labs drawn during 
the study visit for subject convenience, will be included in the subject’s electronic medical record. 
Subjects with access to Mychart will receive results at the same time as the investigator. The 
mechanistic sample results will not be available to the subject. There is a remote chance that a 
previously unknown condition could be discovered while examining a subject’s blood sample or 
during clinical assessments. Although unlikely, if this was to occur the investigator or study team 
member would contact the subject and suggest an appropriate medical referral. Subjects will be 
notified confidentially of their HIV testing results. Subjects who are found to be HIV positive 
will be notified confidentially by an Investigator and offered counseling about HIV infection and 
notification of any partners. If the subject prefers to receive counseling regarding their HIV status 
from their Primary Care Physician or another doctor, then the study team will arrange this.  
6. CONCOMITANT AND DISALLOWED MEDICATIONS 
6.1 Concomitant 
• 
Prednisone (or equivalent corticosteroid) must be < 10 mg/ day and stable for at least 4 weeks 
prior to baseline.  
• 
Hydroxychloroquine must be stable for at least 12 weeks. 
• 
Cholinergic stimulant (e.g. pilocarpine, cevimeline) dose must be stable for at least 4 weeks. 
6.2 Disallowed 
• 
Anticholinergic agents (such as tricyclic antidepressants, antihistamines, phenothiazines, 
antiparkinsonian drugs, anti-asthmatic medications, or gastrointestinal (GI) medications that 
cause xerostomia in more than 10% of patients). 
• 
Rituximab within 2 years of baseline 
• 
Cyclophosphamide within 24 weeks of baseline. 
• 
Azathioprine, cyclosporine, methotrexate, mycophenolate mofetil within 8 weeks of baseline.  
• 
Etanercept within 4 weeks of baseline. 
• 
Adalimumab within 8 weeks of baseline. 
• 
Infliximab within 12 weeks of baseline. 
• 
Golimumab within 8 weeks of baseline. 
• 
Certolizumab pegol within 8 weeks of baseline. 


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• Abatacept within 16 weeks of baseline. 
• Tocilizumab SQ within 4 weeks of baseline.  Tocilizumab IV within 16 weeks of baseline. 
• Tofacitinib or Tofacitinib XR within 4 weeks of baseline.  
7. SUBJECT WITHDRAWALS 
Subjects will be advised in the written informed consent that they have the right to withdraw from the 
study at any time without loss of benefit or medical care to which they are entitled to. Subjects may be 
withdrawn from the study without their consent at the discretion of the PI and/or Sponsor for any reason 
including:  subject  non-compliance,  termination  of  funding,  worsening  of  the  disease  under  study, 
intercurrent illness, or a positive pregnancy test. Subjects who are withdrawn from the study after the 
baseline visit will not be replaced. They will be asked to return for an early termination visit for final 
assessments.  
8. STUDY DRUG ADMINISTRATION 
 8.1. STELARA® (Ustekinumab)  
Ustekinumab is FDA approved and marketed in the US for Crohn’s disease, plaque psoriasis and 
psoriatic arthritis.  This study will examine the efficacy of ustekinumab in patients that have been 
diagnosed  with  Sjogren’s Syndrome.  
  Sjogren’s  Syndrome  
is  mechanistically  
similar  
to  other 
autoimmune diseases for which ustekinmab is approved to treat, therefore there is no significant 
increase in risk in using ustekinmab in this population.  Outcomes of this study will not be used 
to support significant change in labeling of the drug, advertising of the drug and are not intended 
to  promote  or  commercialize  
the  drug.  
  The  study  will  be  conducted  
in  compliance  with  
the 
requirements for review by and IRB (21 CFR part 56) and with the requirements for informed 
consent (21 CFR part 50).  Therefore, this study is IND exempt.  Drug will be supplied, packaged 
and labeled by Janssen Pharmaceuticals. 
 8.2. Accountability of Investigational Supplies 
Ustekinumab will be controlled and monitored in the Investigational Drug Pharmacy.  A label 
will  be  developed  for  the  drug  and  placed  on  the  syringes  for  the  study  team. 
Ustekinumab  will  be  disposed  of  following  the  Investigational  Drug  Pharmacy 
destruction of study drugs by the Investigational drug service SOP after expiration and 
at the end of the study.  
9. SAFETY AND REPORTABLE EVENTS 
9.1. Management of Safety Data 
This Study has been designated as an interventional study. 
 As such, all adverse events for Janssen 
Medicinal Products regardless of causality and special situations excluding those from subjects 
not exposed to a Janssen Medicinal Product and product quality complaints with or without an 
adverse event as described in this Exhibit will be reported from the time a subject has signed and 
dated  an  Informed  Consent  Form  (ICF)  until  completion  of  the  subject’s  last  study-related 
procedure  
(which  may  
include  contact  
for  
follow-up  safety).  
  Serious  adverse  events  will  be 
reported for 30 days after the last dose of study drug. 
For  the  purposes  of  this  study,  the  Janssen  medicinal  product  is:                          
Stelara (ustekinumab) 


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9.2. Definitions 
Adverse Event (AE):  
Any untoward medical occurrence in a clinical study subject administered a medicinal 
(investigational or non-investigational) product. An adverse event does not necessarily have a 
causal relationship with the treatment. An adverse event can therefore be any unfavorable and 
unintended sign (including an abnormal finding), symptom, or disease temporally associated with 
the use of a medicinal (investigational or non- investigational) product, whether or not related to 
that medicinal (investigational or non-investigational) product. (Definition per International 
Conference on Harmonization [ICH]). 
This includes any occurrence that is new in onset or aggravated in severity or frequency from the 
baseline condition, or abnormal results of diagnostic procedures, including laboratory test 
abnormalities. 
Adverse Events of Special Interest:  
Events that the COMPANY is actively monitoring as a result of a previously identified signal 
(even if non-serious). 
In addition to the usual expedited reporting of all “serious” adverse events (per ICH criteria), 
the following AEs of special interest must also be reported to Janssen in an expedited fashion, 
i.e., per SAE reporting timelines, even when not serious (AE does not meet any of the ICH 
serious AE criteria): 
• 
All malignancies 
• 
All cases of active tuberculosis (TB) 
Special consideration should be given to reporting adverse events that are opportunistic infections 
and clinically significant as serious adverse events based on the “otherwise medically significant” 
criteria for seriousness, when they do not meet other Serious AE ICH criteria (e.g., 
hospitalization). 
 Individual Case Safety Report (ICSR):  
A valid ICSR must contain the four minimum criteria required to meet regulatory reporting 
requirements. 
• 
an identifiable subject (but not disclosing personal information such as the subject’s name, 
initials or address) 
• 
an identifiable reporter (investigational site) 
• 
a Janssen medicinal product 
• 
an adverse event, outcome, or certain special situations 
The minimum information required is: 
• 
suspected Janssen medicinal product (doses, indication) 
• 
date of therapy (start and end date, if available) 
• 
batch or lot number, if available 
• 
subject details (subject ID and country) 
• 
gender 
• 
age at AE onset 


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• 
reporter ID 
• 
adverse event detail (AE verbatim in English), onset date, relatedness, causality, action 
taken, outcome, (if available) 
• 
Janssen protocol ID 
Product Quality Complaint (PQC): 
A product quality compliant is defined as any suspicion of a product defect related to a potential 
quality issue during manufacturing, packaging, release testing, stability monitoring, dose 
preparation, storage or distribution of the product, or delivery system.  Not all PQCs involve a 
subject.  Lot and batch numbers are of high significance and need to be collected whenever 
available. Examples of PQC include but not limited to: 
• 
Functional Problem: e.g., altered delivery rate in a controlled release product 
• 
Physical Defect:  e.g. abnormal odor, broken or crushed tablets/capsules 
• 
Potential Dosing Device Malfunction: e.g., autoinjector button not working, needle 
detaching from syringe 
• 
Suspected Contamination 
• 
Suspected Counterfeit 
Serious Adverse Event (SAE): 
A serious adverse event based on ICH and EU Guidelines on Pharmacovigilance for Medicinal 
Products for Human Use is any untoward medical occurrence that at any dose: 
• 
Results in death 
• 
Is life-threatening 
• 
(The subject was at risk of death at the time of the event. It does not refer to an event that 
hypothetically might have caused death if it were more severe.) 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• 
Results in persistent or significant disability/incapacity 
• 
Is a congenital anomaly/birth defect 
• 
Is a suspected transmission of any infectious agent via a medicinal product 
• 
Is medically important* 
*Medical and scientific judgment should be exercised in deciding whether expedited reporting is  
also appropriate in other situations, such as important medical events that may not be immediately 
life threatening or result in death or hospitalization but may jeopardize the subject or may require 
intervention to prevent one of the other outcomes listed in the definition above. These should 
usually be considered serious. 
NOTE: DEATH FOR ANY REASON SHOULD BE REPORTED AS A SERIOUS ADVERSE 
EVENT. 
Hospitalization: 
For reports of hospitalization, it is the sign, symptom or diagnosis which led to the hospitalization 
that is the serious event for which details must be provided. Any event requiring hospitalization 
or prolongation of hospitalization that occurs during the study must be reported as a serious 
adverse event, except hospitalizations for the following: 
• 
Hospitalizations not intended to treat an acute illness or adverse event (e.g., social 
reasons such as pending placement in long-term care facility) 
• 
Surgery or procedure planned before entry into the study. [Note: Hospitalizations that 
were planned before the start of data collection and where the underlying condition for 


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which the hospitalization was planned has not worsened will not be considered serious 
adverse events. Any adverse event that results in a prolongation of the originally planned 
hospitalization is to be reported as a new serious adverse event.] 
Life-Threatening Conditions:  
The cause of death of a subject in a study within 30-days of the last dose of study drug, whether 
or not the event is expected or associated with the study drug, is considered a serious adverse 
event.  
Disease progression should not be recorded as an adverse event or serious adverse event term; 
instead, signs and symptoms of clinical sequelae resulting from disease progression/lack of 
efficacy will be reported if they fulfill the serious adverse event definition.  
Unlisted (Unexpected) Adverse Event/Reference Safety Information: 
An adverse event is considered unlisted if the nature or severity is not consistent with the 
applicable product reference safety information. For a medicinal product(s) with a marketing 
authorization, the expectedness of an adverse event will be determined by whether or not it is listed 
in the applicable product information. For Stelara (ustekinumab), the link to the package insert is:                   
http://www.stelarahcp.com/pdf/PrescribingInformation.pdf 
9.3. Special Reporting Situations  
Safety events of interest for a Janssen medicinal product that require expediting reporting and/or safety 
evaluation include, but are not limited to: 
• 
Drug exposure during pregnancy (maternal) 
• 
Overdose of a Janssen medicinal product  
• 
Exposure to a Janssen medicinal product from breastfeeding  
• 
Suspected abuse/misuse of a Janssen medicinal product 
• 
Inadvertent or accidental exposure to a Janssen medicinal product  
• 
Any failure of expected pharmacological action (i.e., lack of effect) of a Janssen medicinal 
product 
• 
Medication error involving a Janssen medicinal product (with or without patient exposure to 
the Janssen medicinal product, e.g., name confusion) 
• 
Suspected transmission of any infectious agent via administration of a medicinal product 
• 
Unexpected therapeutic or clinical benefit from use of a Janssen medicinal product 
These safety events may not meet the definition of an adverse event; however, from a  
COMPANY perspective, they are treated in the same manner as adverse events. Special situations 
should be recorded on the Adverse Event page of the CRF. 
Any special situation that meets the criteria of a serious adverse event should be recorded on a 
Serious Adverse Event Report Form and be reported to the COMPANY within 24 hours of 
becoming aware of the event. 
9.4. Pregnancy  
All initial reports of pregnancy must be reported to the COMPANY by the PRINCIPAL  
INVESTIGATOR within 24 hours of becoming aware of the event using the Serious 
Adverse Event Form. Abnormal pregnancy outcomes (e.g. spontaneous abortion, fetal death, 


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stillbirth, congenital anomaly, ectopic pregnancy) are considered serious adverse events and 
must be reported using the Serious Adverse Event Form. 
Any subject who becomes pregnant during the study must discontinue further study treatment. 
Because the Janssen Medicinal Product may have an effect on sperm, pregnancies in partners of 
male subjects exposed to a Janssen Medicinal Product will be reported by the Investigator within 
twenty-four hours of their knowledge of the event using the Serious Adverse Event Form. 
Depending on local legislation, this may require prior consent of the partner.  
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the 
infant will be required.  
9.5. Maintenance of Safety Information 
All safety data should be maintained in a clinical database in a retrievable format. The 
INSTITUTION and PRINCIPAL INVESTIGATOR shall provide all adverse events, both 
serious and non-serious, in report format. However, in certain circumstances more frequent 
provision of safety data may be necessary, e.g. to fulfill a regulatory request, and as such the data 
shall be made available within a reasonable timeframe at the COMPANY’s request. 
9.6. Procedures for Reporting Safety Data and Product Quality Complaints (PQCs) for Janssen 
Medicinal Products to the COMPANY 
All adverse events and special situations whether serious or non-serious, related or not related, 
following exposure to a Janssen medicinal product are to be documented by the investigator and 
recorded in the CRF and in the subject’s source records. Investigators must record in the CRF 
their opinion concerning the relationship of the adverse event to a Janssen medicinal product.  
All (serious and non-serious) adverse events reported for a Janssen medicinal product should be 
followed-up in accordance with clinical practice.  
SAEs, Adverse Events of Special Interest and Special Reporting Situations 
All serious adverse events that have not resolved by the end of the study, or that have not resolved 
upon discontinuation of the subject's participation in the study, must be followed until any of the 
following occurs: 
• 
The event resolves 
• 
The event stabilizes 
• 
The event returns to baseline, if a baseline value/status is available 
• 
The event can be attributed to agents other than the study drug or to factors unrelated to 
study conduct  
• 
It becomes unlikely that any additional information can be obtained (subject or health 
care practitioner refusal to provide additional information, lost to follow-up after 
demonstration of due diligence with follow-up efforts) 
The INSTITUTION and the PRINCIPAL INVESTIGATOR) will transmit all SAEs, Adverse 
Events of Special Interest and special situations following exposure to a Janssen product under 
study in a form provided by the COMPANY in accordance with Transmission Methods listed 
below, in English within 24-hours of becoming aware of the event(s). 


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In the event the study is blinded, the PRINCIPAL INVESTIGATOR will submit an unblinded 
SAE or pregnancy exposure report to COMPANY. 
All follow-up information for serious adverse events that are not resolved at the end of the study 
or by the time of patient withdrawal must be reported directly by the PRINCIPAL 
INVESTIGATOR, within 24 hours becoming aware, to the COMPANY using the COMPANY’s 
Serious Adverse Event Report  
All available clinical information relevant to the evaluation of a related SAE, Adverse Events of 
Special Interest or special situation is required. 
• 
The INSTITUTION and/or INVESTIGATOR is responsible for ensuring that these cases are 
complete and if not are promptly followed-up. A safety report is not considered complete until 
all clinical details needed to interpret the case are received. Reporting of follow-up information 
should follow the same timeline as initial reports. 
• 
Copies of any and all relevant correspondences with regulatory authorities and ethics 
committees regarding any and all serious adverse events, irrespective of association with the 
Janssen Product under study, are to be provided to the COMPANY using a transmission 
method listed below within 24 hours of such report or correspondence being sent to applicable 
health authorities. 
Non-Serious AEs 
All non-serious adverse events should be reported to COMPANY according to the timeframe 
outlined in the Research Funding Agreement section entitled Reporting of Data. 
PQC Reporting 
A PQC may have an impact on the safety and efficacy of the product. Timely, accurate, and 
complete reporting and analysis of PQC information from studies are crucial for the protection 
of patients, investigators, and the COMPANY, and are mandated by regulatory agencies 
worldwide. The COMPANY has established procedures in conformity with regulatory 
requirements worldwide to ensure appropriate reporting of PQC information. Lot and/or Batch 
#s shall be collected or any reports failure of expected pharmacological action (i.e., lack of 
effect). The product should be quarantined immediately and if possible, take a picture. 
All initial PQCs involving a Janssen medicinal product under study must be reported to the 
COMPANY by the PRINCIPAL INVESTIGATOR within 24 hours after being made aware of 
the event. The Janssen contact will provide additional information/form to be completed.  
If the defect for a Janssen medicinal product under study is combined with either a serious adverse 
event or non-serious adverse event, the PRINCIPAL INVESTIGATOR must report the PQC to 
the COMPANY according to the serious adverse event reporting timelines.  A sample of the 
suspected product should be maintained for further investigation if requested by the COMPANY. 
9.7. Transmission Methods 
The following methods are acceptable for transmission of safety information to the COMPANY: 
• 
Electronically 
via 
Janssen 
SECURE 
Email 
service 
(preferred) 
IIS-BIO-
VIROGCO@its.jnj.com 


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STUDY 3820 
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• 
For business continuity purposes, if SECURE Email is non-functional: 
o Facsimile (fax), receipt of which is evidenced in a successful fax transmission 
report to 1-866-451-0371 o Telephone (if fax is non-functional). 
9.8. SAEs Listing 
At a minimum, on a semi-annual basis and at the end of the Study, COMPANY will provide to 
the INSTITUTION and/or PRINCIPAL INVESTIGATOR, a listing of all SAEs reported to the 
COMPANY.  SPONSOR and/or PRINCIPAL INVESTIGATOR will review this listing and will 
resolve any discrepancies with the data provided by the COMPANY.  
9.9. Recording Adverse Events 
At each subject visit, the site study staff will assess adverse events by recording all voluntary 
complaints of the subject and by assessment of clinical and laboratory features. At each study 
visit, the subject should be questioned directly regarding the occurrence of any adverse 
experience since his/ her last visit.  
All adverse events, whether observed by the Investigator, elicited from or volunteered by the 
subject, should be documented. Each adverse event will include a brief description of the 
experience, the date of onset, the date of resolution, the duration and type of experience, the 
severity, the relationship to investigational product, contributing factors, and any action taken 
with respect to the study drug.  
All adverse events will be recorded from the time the subject signs consent at the screening visit 
until the subject completes the study or withdraws from participation. Adverse events will be 
followed until the event is resolved or stabilized. These events will be reported to the PI who is 
a physician or another physician member of the study team. They will provide the necessary 
referral or follow-up for appropriate medical care and safety purposes. They will also determine 
if the adverse event is attributable to a study procedure. Adverse events attributable to a study 
procedure, other than those known and indicated in the Risk Section of the protocol, will be 
tracked and reported to the Research Subjects Review Board (RSRB) at the time of continuing 
review.  
9.10. Responsibilities for Reporting Serious Adverse Events to Local Regulatory Authorities 
Serious adverse events related to study procedures that occur between the baseline visit and 
subject completion of or withdrawal from the study, will be reported to the Research Subjects 
Review Board (RSRB) within 10 days of the study team learning of the event.  Adverse events  
that are determined by the PI and physician investigator to increase risk to study subjects will be 
reported to the RSRB within 2 business days of that determination and the PI will voluntarily 
temporarily suspend enrollment of new subjects to that group of the study until appropriate 
changes to ensure adequate safety for the subjects have been implemented prior to continued 
enrollment. The study staff will record all serious adverse experiences that occur during the study 
period in the appropriate source documents and/or AE log as applicable.  
10. RISK ASSESSMENT 
10.1. Potential Drug-Related Risks 
In this section, the following terms are used:  
  


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• Very common:  affects more than 1 user in 10 
• Common:  affects 1 to 10 users in 100 
• Uncommon:  affects 1 to 10 users in 1,000 
• Rare:  affects 1 to 10 users in 10,000 
Very Common: 
• None  
Common: 
• Headache 
• Dizziness 
• Diarrhea 
• Nausea 
• Itchiness 
• Infection of the throat, airway, or sinus 
• Sore throat 
• Fatigue 
• Redness or pain at the drug injection site 
• Back, joint or muscle pain 
• Vomiting 
Uncommon: 
• Swelling,  itching,  hardness,  bleeding,  bruising  and  irritation  where  the  injection  is  given.  
Shingles (a painful rash) 
• Depression 
• Inflammation of tissue under the skin.  Signs include warmth, swelling, redness and pain 
• nasal congestion 
• a form of psoriasis with raised bumps on the skin that are filled with pus 
• Allergic reactions including rash or raised, itchy bumps 
• tooth infections 
• acne 
• feeling weak 
• vaginal yeast infection 
• chest infection 
Rare: 
• Serious allergic reactions, which could be life-threatening (including low blood pressure, trouble 
breathing, swollen face, lips, mouth and/or throat) 
• A form of psoriasis with redness and scaling of a much larger area of your skin or your entire body 
(erythrodermic psoriasis) 
• In rare cases, symptoms such as cough, shortness of breath, and fever  may also be a sign of an 
allergic lung reaction to Ustekinumab 
• Inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps, 
fever or joint pain (vasculitis). 
Infections 
Ustekinumab is a drug that may change how the body fights infections.  


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Serious infections requiring hospitalization for medical observation and /or treatment have been seen in 
Ustekinumab studies. Some of these infections have also been life threatening. Subjects will be advised to 
tell a study doctor if they have a new infection, if an infection keeps coming back, or if they experience 
any signs of infection such as: 
• fever 
• chills 
• headache  coughing 
• congestion 
• chest tightness 
• shortness of breath 
• flu-like symptoms 
• night sweats 
• nausea 
• vomiting 
• diarrhea 
• increased frequency or burning while passing urine 
• redness warmth, tenderness or swelling of skin or joint  
• cold sores 
• new or worsening of pain in any location 
• weight loss 
• tiredness 
Fungal infections have been reported in subjects taking Ustekinumab.  Some of these fungal infections 
can be serious and involve internal organs Subjects will be advised which fungal infections are common 
where they live and/or travel and what symptoms they might cause. Subjects will be advised to tell a 
study doctor and their family physician right away if they develop symptoms of such illnesses.  
It is unknown if Ustekinumab may stop the development of a fever in the event of an infection and therefore 
make an infection harder to diagnose. 
Subjects who receive Ustekinumab may also be at a greater risk for certain serious infections such as 
tuberculosis. Subjects will be screened for tuberculosis via QuantiFERON TB-Gold blood test prior to 
administration of Ustekinumab. Subjects will be encouraged to tell a study doctor if they develop: 
• a cough that does not go away 
• coughing up blood 
• shortness of breath 
• fever 
• night sweats 
• weight loss 
Cancer 
Cancers have been reported in subjects who have received Ustekinumab but it is unknown whether taking 
Ustekinumab has increased their risk for developing cancer.  Because Ustekinumab may suppress the 
immune system, it is possible that it may increase the risk of developing cancer, including skin cancers. 
Subjects who have been diagnosed with psoriasis have a higher chance of developing skin cancers.   


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It is known that people who have had inflammatory diseases (such as, Crohn’s disease, Rheumatoid 
Arthritis, Ulcerative Colitis etc.) for a long time and who use immunosuppressive therapies (such as, 
azathioprine, methotrexate etc.) for a long time have a higher risk of developing cancer. These people get 
cancer of the lymph nodes more often than other people. 
Infusion reactions, Injection Site Reactions and Allergic Reactions    
Ustekinumab may cause an allergic reaction in some people. These reactions are usually mild to moderate.  
The following can be symptoms of an allergic reaction:  
• 
Fever 
• 
Chills 
• 
Hives 
• 
Rash 
• 
Swelling 
• 
Itching 
• 
Headache 
• 
Nausea 
• 
Flushing 
• 
Light headedness 
• 
Chest pain or tightness 
• 
Wheezing 
• 
Difficulty in swallowing or breathing 
• 
Decrease or increase in blood pressure 
• 
Anaphylaxis (life-threatening allergic reaction 
Serious allergic reactions have been reported in subjects taking Ustekinumab and can be life threatening.   
Signs of a serious allergic reaction include skin rash, swollen face, mouth, lips, and/or throat, and trouble 
breathing.   
Another type of allergic reaction has occurred in some subjects 1-14 days after receiving similar 
medications. The symptoms of this type of allergic reaction may include fever, rash, muscle aches and 
joint pain. 
Sometimes the body can make special antibodies that may increase the risk of an allergic reaction to either 
Ustekinumab or other antibody medicines. 
Ustekinumab may affect the response to allergy injections. 
Latex allergy 
The needle cover for the prefilled syringe that contains study drug contains dry natural rubber (a form of 
latex). This may cause allergic reactions in people who are sensitive to latex.   
Cardiac and Vascular 
Heart attacks and strokes have been reported in subjects who have received Ustekinumab.  These events 
have rarely resulted in death.  It is unknown whether taking Ustekinumab increases the risk for 
developing these events.   
People who have psoriasis, and certain other inflammatory diseases, have a higher risk of heart attacks. 
These people have heart attaches more often than other people.  


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Vaccination 
Subjects cannot receive most kinds of live vaccines (for example, FluMist™, varicella) during the study 
or for 3 months after the last study injection. Subjects also cannot receive a BCG vaccine during this 
study or for 12 months after the last study injection. Other kinds of vaccines, like tetanus, flu shots, and 
COVID vaccines that are not live are allowed. It is not known if Ustekinumab may interfere with them 
from working.   
Other Risks 
Two cases of a very rare disease of the brain, posterior reversible encephalopathy syndrome 
(PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were 
reported in clinical studies with Ustekinumab. PRES is generally reversible and is not caused by 
an infection. It is unknown whether taking Ustekinumab increases your risk of developing 
PRES/RPLS.  Symptoms of this condition are: 
• 
Headache 
• 
Seizures 
• 
Confusion 
• 
Loss of eyesight 
10.2. Other Potential Risks Subcutaneous 
Injection/ Infusion 
Injection or infusion of a medication may cause temporary discomfort or pain, bleeding, bruising or 
phlebitis at the site. As with any insertion of a needle into the skin, there is a small risk of infection. The 
risks of injection and infusion will be reduced by its performance by a trained nurse. If subjects have a mild 
infusion reaction (such as itchy skin or back pain) the infusion will be paused and then restarted at a slower 
rate. If subjects have a serious allergic reaction the infusion will be stopped immediately and emergency 
medications will be administered as needed. The infusion center has a crash cart that will be available 
during all infusions.    
Infusion Pre-Medication: Allegra may cause drowsiness. Acetaminophen may cause liver damage in high 
doses. Part of the screening bloodwork includes liver function tests (AST/ALT) to exclude anyone who 
may have impaired liver function and might be susceptible to acetaminophen side effects.   
Blood Drawing  
Blood drawing may cause momentary discomfort or pain, bleeding, bruising, or phlebitis at the site. As 
with any insertion of a needle into the skin, there is a small risk of infection. Occasionally the subject may 
become dizzy or even faint. The risks of phlebotomy will be reduced by its performance by trained 
phlebotomists. Subjects will be seated during the blood draw to minimize dizziness and any risk of falling. 
Salivary Flow Assessments 
PSS patients who stop taking their saliva stimulants 48 hours prior to their screening visit appointment may 
notice that their mouth will become drier than normal. Pilocarpine may cause flushing, sweating or 
abdominal discomfort.  
Schirmer’s Test 
PSS patients who stop taking their medication for dry eyes or using lubricating eye drops prior to their 
screening visit appointment may experience some discomfort or itchiness in their eyes or increased redness. 
The paper placed in the subject’s eye may cause some mild irritation or discomfort. There is very little 
chance of infection.  


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Breach of Confidentiality 
To reduce the risk of a breach of confidentiality, data access will be restricted as described below.  
11. POTENTIAL BENEFITS TO SUBJECTS 
There is no data in the treatment of Primary Sjogren’s Syndrome with ustekinumab, and the potential 
benefits are theoretical. The information learned from this study may aide in better understanding of 
the disease and future treatments of it. 
12. REPRODUCTIVE 
The effect of Ustekinumab on human sperm or unborn babies is not known. 
Pregnant women and women who are making breast milk to feed infants cannot participate in this study. 
Female subjects must have a blood test when beginning this study that shows they are not pregnant.  
During this study and for at least -15 weeks after the last dose of study drug, women of childbearing 
potential and men must use proven birth control methods. The study doctor will discuss effective birth 
control methods with the subject.  
Female study subjects will not be permitted to donate eggs during the study and for at least 15 weeks 
after their last dose of study drug. Male subjects will not be permitted to donate sperm during the study 
and for at least 15 weeks after their last dose of study drug.  
Female subjects of childbearing potential will have a serum pregnancy test done at screening and must 
have a negative result to be eligible. Urine pregnancy tests will be done on all dosing visit days and 
must have a negative result prior to receiving IP dose. Male subjects with a female partner of 
childbearing potential will be asked to confirm their birth control methods at each visit.   
Subjects who become pregnant or may have fathered a child while taking part in the study or up to 15 
weeks after their last dose of study drug, will be instructed to notify the study doctor immediately. In 
addition, a study team member will contact female subjects of childbearing potential and male subjects 
with a female of childbearing potential partner by phone 15 weeks after their last dose of study drug to 
see if they have become pregnant.  
Male study subjects who father a child during their participation in this study or within 15 weeks after 
their last dose of study drug, will be asked by the study doctor for their partner’s permission to stay in 
contact with her throughout the length of the pregnancy. The partners will be asked to attend a visit to 
sign a separate pregnant partner consent form.  
If a subject or partner of a subject becomes pregnant during participation or within 15weeks after their 
last dose of study drug, a member of the study team will collect information such as estimated weeks 
of gestation, expected delivery date, and if the pregnancy is a result of contraceptive failure. The study 
doctor or team member will then notify the Company on the subject’s or partner’s behalf. With the 
subject’s or partner’s permission, the PI will reach out to the subject’s or partner’s childbirth doctor to 
notify them that the mother or father received an investigational drug (Ustekinumab).  
Female study subjects who become pregnant during their participation in this study, will stop treatment 
with study drug and may be withdrawn from some of the study procedures. Any subject or partner of 
subject who becomes pregnant during the study or at any point before 15 weeks has passed since the 
last dose of study drug will be followed by the study team until delivery. A telephone contact will be 


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made to the subject or partner within 30 days after the anticipated due date to collect information about 
the outcome of the pregnancy. Data collected may include, but is not limited to, information about 
gestational age at birth, type of delivery as well as any abnormal outcomes (i.e. spontaneous abortion, 
fetal death, stillborn, congenital abnormality, ectopic pregnancy). If the pregnancy results in an 
abnormal outcome, the study doctor will follow SAE reporting procedures. Subjects or partner’s will 
be encouraged to contact the study staff immediately if they do experience an abnormal pregnancy 
outcome.  
13. CONFIDENTIALIATY OF DATA AND INFORMATION STORAGE  
Patients will be assigned a unique study number to identify all samples and data forms. Consent forms 
and data sheets will be maintained in the locked office suite of the department of Allergy, Immunology 
and Rheumatology or in the office of the investigator. All computer entry and networking programs 
will be done with coded numbers only except for an investigator restricted database which will include 
subject’s name and identifiers. Access will be restricted to the investigator and the study team. 
Deidentified information may be shared with collaborators at outside institutions.  
14. RESEARCH INFORMATION IN MEDICAL RECORDS 
Standard of care labs, safety labs and SS disease activity labs, will be resulted in the subject’s medical 
record and will be available to the subject. Mechanistic sample results will not be entered into the 
subject’s medical record and will not be available to the subject.  
15. DATA ANALYSIS AND MONITORING 
15.1. Planned Statistical Analysis 
This study will be used assess the effect of ustekinumab on laboratory/mechanistic parameters, 
and to get a rough estimate of the effect size on clinical parameters. Since ustekinumab has not 
been used for treatment of PSS, and this is a pilot study, the sample size of 15 subjects was picked 
a priori.  
Each subject will perform as its own comparison, baseline vs. week 24. The analysis will also 
capture changes in the measured parameters at week 4, week 12, and week 20.  
All endpoint data will be summarized as a single group using appropriate descriptive statistics. 
For continuous variables, summaries will include the mean, standard deviation or standard error, 
median, minimum, maximum and number of subjects. For ordinal or categorical variables, 
frequencies and percents will be computed. Figures, plots, or other displays will be used as 
necessary to better clarify the nature of the data.  
We assume no dropout rate, given the small sample size and the safety profile of the drug. All 15 
subjects will be analyzed as one population; we do not plan on stratifying into sub-populations, 
as this is a very small study.  However, if there is any unplanned dropout, we will use Intent-
toTreat analysis. This will include all the study subjects who received at least one dose of study 
drug.  
Statistical analysis will be performed with IBM SPSS Statistics V.20 (SPSS, Chicago, Illinois, 
USA). p value<0.05 will be considered statistically significant. 
15.2. Primary Endpoint Analysis 
The primary analysis of primary endpoint, change in ESSPRI between baseline Day 0 and Week 
24 will test the null hypothesis of “no ESSPRI difference between baseline and week 24” using 


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the ITT sample. The primary analysis of treatment effect will be conducted under the ITT 
principle, whereby outcome data from all subjects in the ITT population will be included in the 
analysis regardless of treatment compliance or duration of study participation. As such, for 
subjects who have no assessment at Week 24, the last observation will be carried forward for 
primary analysis.  
15.3. Secondary Endpoint Analysis  
For the secondary efficacy endpoints, differences will be evaluated using p-values derived from 
appropriate test statistics.  
• 
Analyses analogous to those for the primary endpoint will be completed for the 
following: 
o Changes in SF-36 between day 0 and weeks 24. 
• 
Linear mixed models for repeated measures will be used to evaluate treatment effect 
between baseline and week 24 for the continuous scale assessments measured 
longitudinally including: 
o Stimulated and unstimulated whole salivary flow 
o ESSDAI 
o VAS global assessments of symptoms of oral and eye dryness o VAS global 
assessment of fatigue o VAS global assessment of joint pain 
15.4. Safety Analysis 
All safety analyses will be performed using the entire study population. Safety analyses will 
include separate tabulations of AEs occurring prior to treatment and after the first dose of study 
agent (i.e. treatment-emergent AEs). The number of events and number (%) of participants 
experiencing events will be summarized by system organ class and preferred term for each 
treatment group and overall. In addition, AEs will be summarize by a maximum severity and 
relationship to study agent. Separate summaries will also be provided for SAEs, 
treatmentemergent AEs leading to study treatment discontinuation, and treatment-emergent AEs 
that may be related to disease activity. 
15.5. Immunological Analysis 
Due to the exploratory nature of the analyses, descriptive statistics and plots will be used to gain 
an understanding of the data prior to developing any statistical models. Means, medians, standard 
deviations, minimums and maximums will be computed for each continuous mechanistic/ 
immunologic endpoint at each time point. For dichotomous endpoints, frequencies and percents 
will be computed at each time point by study arm and separately for responders and 
nonresponders. 
15.6. Interim Analysis 
No formal analyses are planned for efficacy. Statistical analysis will be performed with IBM 
SPSS Statistics V.20 (SPSS, Chicago, Illinois, USA). P value <0.05 will be considered 
statistically significant.  
15.7. Data and Safety Monitoring 
As this is a small pilot trial, there will not be a data monitoring committee. The PI will be 
responsible for monitoring the progress of the study by reviewing cumulative data throughout 
the study. The PI will review data in real time, but at least quarterly, to ensure the validity and 


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integrity of the data as well as the safety and welfare of the subjects. The PI will also review an 
adverse event log and respond accordingly (please refer to the Adverse Events section). 
16. REFERENCES 
1. 
Katsifis, G.E., N.M. Moutsopoulos, and S.M. Wahl, T lymphocytes in Sjogren's syndrome:  
contributors to and regulators of pathophysiology. Clin Rev Allergy Immunol, 2007. 
32(3): p. 252-64. 
2. 
Mitsias, D.I., E.K. Kapsogeorgou, and H.M. Moutsopoulos, The role of epithelial cells in 
the initiation and perpetuation of autoimmune lesions: lessons from Sjogren's syndrome 
(autoimmune epithelitis). Lupus, 2006. 15(5): p. 255-61. 
3. 
Zheng, Y., et al., Interleukin-22 mediates early host defense against attaching and 
effacing bacterial pathogens. Nat Med, 2008. 14(3): p. 282-9. 
4. 
Katsifis, G.E., et al., Systemic and local interleukin-17 and linked cytokines associated 
with Sjogren's syndrome immunopathogenesis. Am J Pathol, 2009. 175(3): p. 1167-77. 
5. 
Mieliauskaite, D., et al., Expression of IL-17, IL-23 and their receptors in minor salivary 
glands of patients with primary Sjogren's syndrome. Clin Dev Immunol, 2012. 2012: p. 
187258. 
6. 
Rua-Figueroa, I., et al., Comorbidities in patients with Primary Sjogren's Syndrome and 
Systemic Lupus Erythematosus: A comparative registries-based study. Arthritis Care Res 
(Hoboken), 2016. 
7. 
Pillemer, S.R., Lymphoma and other malignancies in primary Sjogren's syndrome. Ann 
Rheum Dis, 2006. 65(6): p. 704-6. 
8. 
Singh, A.G., S. Singh, and E.L. Matteson, Rate, risk factors and causes of mortality in 
patients with Sjogren's syndrome: a systematic review and meta-analysis of cohort 
studies. Rheumatology (Oxford), 2016. 55(3): p. 450-60. 
9. 
Papp, K., et al., Safety Surveillance for Ustekinumab and Other Psoriasis Treatments 
From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Drugs Dermatol, 
2015. 14(7): p. 706-14. 
10. 
Ritchlin, C., et al., Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, 
ustekinumab, in patients with active psoriatic arthritis despite conventional nonbiological 
and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the 
phase 3, multicentre, double-blind, placebo-controlled, randomised  
PSUMMIT 2 trial. Ann Rheum Dis, 2014. 73(6): p. 990-9.11. 
Nguyen, C.Q., S.R. 
Cha, and A.B. Peck, Sjogren's syndrome (SjS)-like disease of mice: the importance of B 
lymphocytes and autoantibodies. Front Biosci, 2007. 12: p. 1767-89. 
12. 
Le Pottier, L., et al., The mosaic of B-cell subsets (with special emphasis on primary 
Sjogren's syndrome). Autoimmun Rev, 2007. 6(3): p. 149-54. 
13. 
Fox, R.I. and M. Stern, Sjogren's syndrome: mechanisms of pathogenesis involve 
interaction of immune and neurosecretory systems. Scand J Rheumatol Suppl, 2002. 116: 
p. 3-13. 
14. 
Mackay, F., J.R. Groom, and S.G. Tangye, An important role for B-cell activation factor 
and B cells in the pathogenesis of Sjogren's syndrome. Curr Opin Rheumatol, 2007. 
19(5): p. 406-13. 


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15. 
Groom, J.R., et al., BAFF and MyD88 signals promote a lupuslike disease independent of 
T cells. J Exp Med, 2007. 204(8): p. 1959-71. 
16. 
Mackay, F. and P. Schneider, Cracking the BAFF code. Nat Rev Immunol, 2009. 9(7): p. 
491-502. 
17. 
Zhang, J., et al., Cutting edge: a role for B lymphocyte stimulator in systemic lupus 
erythematosus. J Immunol, 2001. 166(1): p. 6-10. 
18. 
Cheema, G.S., et al., Elevated serum B lymphocyte stimulator levels in patients with 
systemic immune-based rheumatic diseases. Arthritis Rheum, 2001. 44(6): p. 1313-9. 
19. 
Pers, J.O., et al., BAFF overexpression is associated with autoantibody production in 
autoimmune diseases. Ann N Y Acad Sci, 2005. 1050: p. 34-9. 
20. 
Nguyen, C.Q., et al., Development of Sjogren's syndrome in nonobese diabetic-derived 
autoimmune-prone C57BL/6.NOD-Aec1Aec2 mice is dependent on complement 
component-3. J Immunol, 2007. 179(4): p. 2318-29. 
21. 
Yang, K., et al., TRIM21 is essential to sustain IFN regulatory factor 3 activation during 
antiviral response. J Immunol, 2009. 182(6): p. 3782-92. 
22. 
Dimitriou, I.D., et al., CD40 on salivary gland epithelial cells: high constitutive 
expression by cultured cells from Sjogren's syndrome patients indicating their intrinsic 
activation. Clin Exp Immunol, 2002. 127(2): p. 386-92. 
23. 
Emamian, E.S., et al., Peripheral blood gene expression profiling in Sjogren's 
syndrome.2Genes Immun, 2009. 10(4): p. 285-96. 
24. 
Roescher, N., P.P. Tak, and G.G. Illei, Cytokines in Sjogren's syndrome. Oral Dis, 2009. 
15(8): p. 519-26. 
25. 
Trinchieri, G., Interleukin-12: a cytokine produced by antigen-presenting cells with 
immunoregulatory functions in the generation of T-helper cells type 1 and cytotoxic 
lymphocytes. Blood, 1994. 84(12): p. 4008-27. 
26. 
Vosters, J.L., et al., Interleukin-12 induces salivary gland dysfunction in transgenic mice, 
providing a new model of Sjogren's syndrome. Arthritis Rheum, 2009. 60(12): p. 363341. 

ICF_001.pdf: 
STUDY 3820 
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Version Date: 01Feb2022 
 
NCT04093531  
CONSENT FORM 
Pilot Trial of Ustekinumab for Primary Sjögren’s Syndrome (PSS) 
Principal Investigator: Dr. Ummara Shah 
Sub-Investigators: Dr. Jennifer Anolik 
Sponsor: University of Rochester Medical Center 
Funded by: Janssen Scientific Affairs Inc. 
This consent form describes a research study, what you may expect if you decide 
to take part and important information to help you make your decision.  Please 
read this form carefully and ask questions about anything that is not clear before 
you agree to participate.  You may take this consent form home to think about 
and discuss with family or friends. 
Key Information 
• 
Being in this research study is voluntary – it is your choice. Your medical care will 
not be affected if you decide you do not want to take part in this study.   
• 
You are being asked to take part in this study because of your Sjogren’s Syndrome.  
• 
The purpose of this study is to determine the safety and effect of ustekinumab on 
patients with Sjogren’s Syndrome. 
• 
Your participation in this study will last for about 24 weeks.  
• 
Procedures will include administration of a study drug and visits to assess your 
health.  
• 
There are risks from participating.  
o The most common risk is infection.  
o One of the most serious risks is anaphylaxis (a life threatening allergic 
reaction)  
o See the “Risks of Participation” section in this consent form for more 
information.  You should discuss these risks in detail with the study team. 
• 
You may not benefit from being in this research study.  
Purpose of Study  
Sjogren’s syndrome (SS) is a chronic autoimmune disease, for which no treatment is 
currently available. The purpose of this study is to determine the safety and effect of the 
drug ustekinumab on patients with SS. Ustekinumab has been FDA approved for 
DEPARTMENT OF MEDICINE 
Division of Clinical Allergy, Immunology and Rheumatology 
M EDICINE  of THE H IGHEST O RDER 


STUDY 3820 
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patients with Psoriasis, Psoriatic Arthritis, and Crohn’s Disease and has shown to be a 
safe and therapeutic treatment for these conditions. Ustekinumab has not previously 
been used in the treatment of SS and is not FDA approved for SS treatment. However, 
Psoriasis affects many of the same cells and proteins in the body as SS does. 
Therefore, the purpose of this study is to learn whether or not ustekinumab is safe for 
use in patients with SS, and if it has a similar effect on patients with SS as it does with 
patients with psoriasis.  
Description of Study Procedures 
If you decide to take part in this study, you will be asked to complete a total of 6 visits 
over the course of 24 weeks.  
Visit 1: Screening visit (Up to 2 hours long) 
The procedures performed in this visit will be used to determine if you meet eligibility 
criteria, including confirming your diagnosis of Sjogren’s Syndrome. These procedures 
include: 
• 
Review of your medical history 
• 
Review of adverse events 
• 
Review of your medications 
• 
Complete physical exam  
• 
Vital signs 
• 
Unstimulated salivary flow assessment: You will not be able to eat or drink during 
or for 60 minutes prior to this test. You will be asked to spit into a cup for 15 
minutes. Your saliva will then be weighed in order to determine volume. If you 
are currently taking a drug to increase your saliva flow (such as 
Pilocarpine/ Salagen), you will be asked not to take the medication for 48 
hours prior to this visit. Study staff will call to remind you of this before 
your visit. 
• 
Schirmer’s test: If the results of your unstimulated salivary flow assessment do 
not meet a certain value needed for diagnosis, a Schirmer’s Test will be 
performed. If your unstimulated salivary flow assessment does meet the value 
then this test will be skipped. For this test, a thin filter paper strip will be placed 
behind your lower eyelids on both eyes. You will be asked to close your eyes and 
remain there for five minutes. The paper strip will then be removed and the 
wetness of it will be measured in millimeters. If you are currently taking 
medications to increase tear production (such as Restasis) you will be 
asked not to take the medication for 48 hours prior to this visit. If you 
normally use lubricating eye drops you will be asked not to use them the 
morning of your screening visit appointment. If you normally wear eye 
make-up you will be asked to not wear it to this visit. Study staff will call to 
remind you of this before your visit.  
• 
Blood Draw (28 ml; about 6 tsp): This will include a screen for HIV, Hepatitis 
B&C, Tuberculosis, a pregnancy test (if applicable; if you are a female of 
childbearing potential), safety labs and labs to confirm your diagnosis of SS. 


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o You may have already had some of these labs done as standard of care 
with your normal doctor. Even if you have had them done recently, we will 
not use those results. We will still collect them as part of the research 
study. 
o You will need to sign a separate consent form to be tested for HIV. If you 
are found to be HIV positive, you will not be able to participate in this 
study. You will be notified of the positive result confidentially by your study 
doctor and offered counseling about HIV infection and notification of any 
partners. If you would prefer to receive counseling from your Primary Care 
Physician or another doctor, the study team will arrange this. Per the New  
York State law, your name will be released to the State Department of 
Health. Your medical records will be kept confidential to the extent 
permitted by the law.   
• 
Eligibility criteria checklist 
Visit 2: Baseline Visit (Up to 6 ½ hours long) 
If you qualify for the rest of the study based on the results of your screening visit, you 
will be scheduled for the Baseline visit.  The baseline visit will take place within 4 weeks 
of your screening visit, If you do not qualify for the study based on the results of your 
screening visit, you may be allowed to rescreen 4 weeks after your initial screening visit. 
You will not be allowed to rescreen more than one time.  
• 
Review of eligibility criteria 
• 
Review of changes in your medical history  
• 
Review of changes in your medication 
• 
Targeted physical exam 
• 
Vital signs 
• 
Review of any adverse events 
• 
Unstimulated and Stimulated Salivary flow assessments: For the saliva flow rate 
test, you will be given a drug called Pilocarpine. Pilocarpine is a FDA approved 
drug used to stimulate flow of saliva and comes as a tablet to take by mouth. 
Before and 60 minutes after taking the Pilocarpine, you will be asked to spit into a 
cup for 15 minutes. You will not be able to eat or drink during or for 60 minutes 
prior to the test. If you are currently taking a drug to increase your saliva 
flow, you will be asked not to take the medication for 48 hours prior to this 
visit. Study staff will call to remind you of this before your visit. Your saliva 
will be weighed to determine volume.  
• 
Assessments to measure your disease activity 
• 
Blood draw (120 ml; about 8 tbsp.) and urine collection for safety labs, SS 
disease activity labs and research tests 
• 
Urine pregnancy test / confirmation of birth control methods (if applicable) 
• 
Administration of study drug: you will receive 650mg of acetaminophen and 
60mg allegra at least 30 minutes but not later than 60 minutes before you receive 


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the study drug. These medications are to help prevent an infusion related 
reaction (such as itchy skin or back pain). If you have a history of an allergic 
reaction to either of these pre-medications, you will be offered an equivalent 
substitute. You will then receive an intravenous loading dose of study drug. The 
ratio is 6mg of study drug for every kg of body weight. The amount of drug you 
will receive will be calculated based on your body weight. The infusion will take 
approximately 60 minutes but could take up to 3 hours depending on how well 
you tolerate the infusion. For instance, if you have a mild reaction to the infusion 
the infusion will be paused and restarted at a slower rate. If you have a serious 
reaction to the infusion, the infusion will immediately be stopped and emergency 
medications will be administered if needed. You will be asked to wait for 60 
minutes after the infusion so that you can continue to be monitored for any 
adverse reaction to the drug.  
Visits 3, 4, 5: Week 4, 12, and 20 Visits +/- 4 days (Up to 1 hour long) 
• 
Review of changes in your medical history 
• 
Review of changes in your medication  
• 
Targeted physical exam 
• 
Vital Signs 
• 
Review of any adverse events 
• 
Blood draw for safety, research and SS disease activity lab tests o Week 12 - 
120 ml; about 8 tbsp.  
o Weeks 4 & 20 - 9 ml; about 2 tsp. 
• 
Urine pregnancy test/ confirmation of birth control methods (if applicable) 
• 
Administration of study drug: you will receive 90mg of study drug as a 
subcutaneous (under the skin) injection. You will be asked to wait for 15 minutes 
after the injection in order to monitor you for any adverse reactions to the drug.  
Visit 6: Week 24 +/-4 days / Early Termination Visit (up to 2 hours long) 
• 
Review of changes in your medical history 
• 
Review of changes in your medication  
• 
Targeted physical exam 
• 
Vital Signs 
• 
Review of any adverse event(s) 
• 
Unstimulated and Stimulated Salivary flow assessments: For the saliva flow rate 
test, you will be given a drug called Pilocarpine. Pilocarpine is a FDA approved 
drug used to stimulate flow of saliva and comes as a tablet to take by mouth.  
Before and 60 minutes after taking the Pilocarpine, you will be asked to spit into 
a cup for 15 minutes. You will not be able to eat or drink during or for 60 minutes 
prior to the test. If you are currently taking a drug to increase your saliva 
flow, you will be asked not to take the medication for 48 hours prior to this 


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visit. Study staff will call to remind you of this before your visit. Your saliva 
will be weighed to determine volume.  
• 
Assessments to measure your disease activity  
• 
Blood draw (120 ml; about 8 tbsp.) and urine collection for safety, research and 
SS disease activity lab tests 
Follow-Up Phone Call (for female subjects of childbearing potential and male subjects 
with female partners of child bearing potential only) 
A study team member will call you approximately 15 weeks after your last dose of study 
drug to see if you / your partner have become pregnant. If you / your partner are not 
pregnant then there will be no other follow-up. If you / your partner have become 
pregnant, the study team will follow the procedures as outlined in the reproductive 
section of this consent form.  
Unscheduled visits  
Should you experience symptoms of increased disease activity or new onset symptoms 
in between your normal scheduled visits, you may be asked to come in for an 
unscheduled visit. You will not be paid for unscheduled visits. Unscheduled visits may 
include: 
• 
Review of changes in your medical history 
• 
Review of changes in your medication  
• 
Targeted physical exam 
• 
Vital Signs 
• 
Review of any adverse event(s) 
• 
Blood draw (9 ml; about 2 tsp.) for safety labs 
Information about your study participation and study results may be included in your 
electronic health record. If you have given a health care proxy access to your electronic 
health records, your test results might be accessible to them, including HIV status.  If 
you have concerns about this or to obtain more detail, you should discuss this with the 
study team. 
Number of Subjects 
Approximately 15 subjects will take part in this study.  
Drug Specific Risks 
The possible discomforts, side effects and risks related to ustekinumab treatment are 
not all known.  Most side effects are not serious. Some may be serious and may require 
treatment or additional testing.  This section describes how frequently side effects 
occurred in subjects who were treated with ustekinumab.  
In this section, the following terms are used:   
• 
Very common:  affects more than 1 user in 10 
• 
Common:  affects 1 to 10 users in 100 


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• 
Uncommon:  affects 1 to 10 users in 1,000 
• 
Rare:  affects 1 to 10 users in 10,000 
Very Common: 
• 
None  
Common: 
• 
Infection of the throat, airway or sinus 
• 
Sore throat 
• 
Fatigue 
• 
Redness, pain or itchiness at drug injection site 
• 
Headache 
• 
Dizziness 
• 
Diarrhea 
• 
Nausea/ vomiting 
• 
Back, joint or muscle pain 
Uncommon: 
• 
Swelling, itching, hardness, bleeding, bruising and irritation where the injection is 
given. 
• 
Shingles (a painful rash) 
• 
Depression 
• 
Inflammation of tissue under the skin.  Signs include warmth, swelling, redness 
and pain 
• 
nasal congestion 
• 
a form of psoriasis with raised bumps on the skin that are filled with pus 
• 
Allergic reactions including rash or raised, itchy bumps 
• 
tooth infections 
• 
acne 
• 
feeling weak 
• 
vaginal yeast infection 
• 
chest infection 
Rare: 
• 
Serious allergic reactions, which could be life-threatening (including low blood 
pressure, trouble breathing, swollen face, lips, mouth and/or throat) 
• 
A form of psoriasis with redness and scaling of a much larger area of your skin or 
your entire body (erythrodermic psoriasis) 
• 
In rare cases, symptoms such as cough, shortness of breath, and fever may also 
be a sign of an allergic lung reaction to ustekinumab 
• 
Inflammation of small blood vessels, which can lead to a skin rash with small red 
or purple bumps, fever or joint pain (vasculitis). 
Infections 
Ustekinumab is a drug that may change how your body fights infections.  
Serious infections requiring hospitalization for medical observation and /or treatment 
have been seen in ustekinumab studies. Some of these infections have also been life 
threatening. 


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Tell your study doctor if you have a new infection, if an infection keeps coming back, or 
if you have any signs of infection such as:  
• 
Fever 
• 
Chills 
• 
Headache 
• 
Coughing 
• 
Congestion 
• 
Chest tightness 
• 
Shortness of breath 
• 
Flu-like symptoms 
• 
Night sweats 
• 
Nausea 
• 
Vomiting 
• 
Diarrhea 
• 
Increased frequency or burning while passing urine 
• 
Redness, warmth, tenderness, or swelling of skin or joint 
• 
Cold sores 
• 
New or worsening of pain in any location  
• 
Weight loss 
• 
Tiredness 
  
It is unknown if ustekinumab may stop you from developing a fever if you do have an 
infection, and therefore hide that you have one. 
Fungal infections have been reported in subjects taking ustekinumab.  Some of these 
fungal infections can be serious and involve internal organs. You should find out from 
your study doctor which fungal infections are common where you live or travel and what 
symptoms they cause.  Tell your study doctor and family physician right away if you 
develop symptoms of such illnesses. 
Subjects who receive ustekinumab may also be at a greater risk for certain serious 
infections such as tuberculosis. Tell your study doctor if you have ever had tuberculosis 
or anybody in your family has ever had tuberculosis or if you come in contact with 
someone who has tuberculosis. Tell your study doctor if you develop: 
• 
a cough that does not go away 
• 
coughing up blood 
• 
shortness of breath 
• 
fever 
• 
night sweats 
• 
weight loss  
Cancer 
Cancers have been reported in subjects who have received ustekinumab but it is 
unknown whether taking ustekinumab has increased their risk for developing cancer.  
Because ustekinumab may suppress your immune system, it is possible that it may 
increase your risk of developing cancer, including skin cancers. Subjects who have 


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been diagnosed with psoriasis have a higher chance of developing skin cancers. Tell 
your doctor if you have any new or changing skin lesions.    
It is known that people who have had inflammatory diseases (such as, Crohn’s disease, 
Rheumatoid Arthritis, Ulcerative Colitis etc.) for a long time and who use 
immunosuppressive therapies (such as, azathioprine, methotrexate etc.) for a long time 
have a higher risk of developing cancer. These people get cancer of the lymph nodes 
more often than other people.  
Infusion Reactions, Injection Site Reactions and Allergic Reactions    
Ustekinumab may cause an allergic reaction in some people. These reactions are 
usually mild to moderate. Your body might have a reaction during or shortly following an 
infusion of Ustekinumab into the vein. This is called an infusion reaction and these 
reactions are usually mild to moderate. They are managed by slowing the infusion or by 
giving you a medication. The following can be symptoms of an infusion reaction or an 
allergic reaction:  
• Fever 
• Chills 
• Hives 
• Rash  Swelling 
• Itching 
• Headache 
• Nausea 
• Flushing 
• Light-headedness 
• Chest pain or tightness 
• Wheezing 
• Difficulty in swallowing or breathing 
• Decrease or increase in blood pressure 
• Anaphylaxis (life-threatening allergic reaction) 
Serious allergic reactions have been reported in subjects taking ustekinumab and can 
be life threatening. If this happens during the infusion, the infusion will be stopped, 
Signs of a serious allergic reaction include skin rash, swollen face, mouth, lips, and/or 
throat, and trouble breathing.  Tell your doctor or get emergency medical help right 
away if you have an allergic reaction.  If you experience a serious reaction to an 
injection, you will not receive any more study treatments. 
If you have an infusion reaction or an allergic reaction at the doctor’s office, additional 
necessary treatment will be provided immediately.  Your study doctor may give you an 
antihistamine (medication used to treat allergic symptoms such as hay fever) or other 
medications used for treating an allergy. Antihistamines can make you sleepy, so 
please use caution when driving a car or operating machinery.  
Another type of allergic reaction has occurred in some subjects 1-14 days after 
receiving similar medications. The symptoms of this type of allergic reaction may 
include fever, rash, muscle aches and joint pain. 


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Antibodies to Ustekinumab 
Sometimes the body can make special antibodies that may increase the risk of an 
allergic reaction to either ustekinumab or other antibody medicines. If you have an 
allergic reaction, you may not be able to have these types of medications in the future. 
You should always tell your doctors that you have been treated with human antibodies 
in this study. 
Latex Allergy 
The needle cover for the prefilled syringe that contains study drug contains dry natural 
rubber (a form of latex). This may cause allergic reactions in people who are sensitive to 
latex.  Please tell your study doctor if you have ever had an allergic reaction or 
sensitivity to latex. You will not be able to take part in this study if you have a history of 
a life-threatening reaction to latex. 
Cardiac and Vascular 
Heart attacks and strokes have been reported in subjects who have received 
ustekinumab.  These events have rarely resulted in death.  It is unknown whether taking 
ustekinumab increases your risk for developing these events.   
People who have certain other inflammatory diseases, have a higher risk of having 
heart attacks.  These people have heart attacks more often than other people.  You 
should seek medical care immediately if you develop;  
• 
Chest pain or discomfort 
• 
Trouble breathing 
• 
Irregular heartbeats 
• 
Dizziness 
• 
Loss of balance 
• 
New numbness or weakness 
• 
Visual or speech changes  
Vaccination 
Vaccines are made to help protect people from certain illnesses. Some vaccines are 
made from live bacteria or live viruses. You cannot receive most kinds of live 
vaccines (for example, FluMist™, varicella) during the study or for 3 months after 
the last study injection.  Another kind of live vaccine is BCG, which is a vaccine 
against tuberculosis.  You cannot receive a BCG vaccine during this study (from 
your first visit on) or for 12 months after the last study injection. You could get sick 
from these kinds of vaccines while on ustekinumab. If you do get a live vaccination 
during this study, you must tell your study doctor immediately. 
Tell your study doctor if anyone living in your home needs a live vaccine.  Some viruses 
used in live vaccines can spread from a close contact (someone living in your home) to 
people with a weakened immune system. 
Other kinds of vaccines, like tetanus and flu shots, and COVID vaccines that are not 
live, are allowed. It is not known if ustekinumab may interfere with them from working.  
Tell your study doctor before getting any vaccine while you are in this study.   


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Other Therapies 
Tell your doctor if you are receiving treatments that weaken the immune system while 
using ustekinumab (For example, oral steroid medicines or biologics).  These treatment 
combinations have not each been studied with ustekinumab, so it is unknown if they 
could possibly increase the risk of diseases related to a weakened immune system.  
Tell your study doctor if you have ever had or are now getting allergy injections. 
ustekinumab may affect your response to allergy injections. 
Other Drug Risk 
Two cases of a very rare disease of the brain, posterior reversible encephalopathy 
syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy 
Syndrome (RPLS), were reported in clinical studies with Ustekinumab. PRES is 
generally reversible and is not caused by an infection. It is unknown whether taking 
Ustekinumab increases your risk of developing PRES/RPLS.Symptoms of this condition 
are: 
• 
Headache 
• 
Seizures 
• 
Confusion 
• 
Loss of eyesight 
Tell your study doctor if you experience any of these symptoms. 
 There may be other discomforts or risks to you from this study that are not yet known.  
Your study doctor and staff will ask you about any side effects that you may have at 
every visit.  If you have any problems, you should let your study doctor know right away. 
Tell your doctors or dentist that you are or have been in a study where ustekinumab (an 
anti IL-12 and anti IL-23 drug) is the study drug.  This is important if you have any 
surgery, dental procedures, or receive treatment for any other medical condition.  
Other Risks of Participation  
Subcutaneous Injection/ Infusion: Injection or infusion of a medication may cause 
temporary discomfort or pain, bleeding, bruising or phlebitis at the site. As with any 
insertion of a needle into the skin, there is a small risk of infection. The risks of injection 
will be reduced by its performance by a trained physician.  
Infusion Pre-Medication: Allegra may cause drowsiness. Acetaminophen may cause liver 
damage in high doses. Part of the screening bloodwork includes liver function tests 
(AST/ALT) to exclude anyone who may have impaired liver function and might be 
susceptible to acetaminophen side effects.   
Blood Drawing: Blood drawing may cause momentary discomfort or pain, bleeding, 
bruising, or phlebitis at the site. As with any insertion of a needle into the skin, there is a 
small risk of infection. Occasionally the subject may become dizzy or even faint. The 
risks of phlebotomy will be reduced by its performance by trained phlebotomists. 
Subjects will be seated during the blood draw to minimize dizziness and any risk of 
falling. 


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Salivary Flow: If you normally take a salivary stimulant, you will have to hold the 
medication for 48 hours prior to the salivary flow assessments. This may make your 
mouth feel drier than normal. The Pilocarpine that is given may cause flushing, 
sweating, or abdominal symptoms.  
Schirmer’s Test: If you normally take a medication for dry eyes or use lubricating eye 
drops, you will have to hold them prior to the Schirmer’s Test. This may cause you to 
experience some discomfort or itchiness in your eyes or increased redness. The filter 
paper placed in your eye for the test may cause some mild irritation or discomfort. There 
is very little chance of infection.  
Unknown Risks: The investigational treatments may have unknown side effects. The 
researchers will let you know if they learn anything that might make you change your 
mind about participating in the study. Though highly unlikely, if a previously unknown 
condition is discovered, you will be informed and an appropriate medical referral will be 
suggested. 
Confidentiality: There is a risk of losing confidentiality of your information that is used in 
this study. However, steps have been and will be taken to help ensure that this does not 
occur. To protect subject health care information, each subject will be assigned a study 
number that will be used on all data sheets and to label all samples. The information will 
be de-identified and will be kept locked in an office and will only be available to the 
research staff. After the study is completed, the data may be placed in a central storage 
location or public database. This will include all of the information learned from this 
study and not just information specific to you. Any data will not include your name or 
other information that can identify you. The purpose is to make study data available to 
other researchers who must request permission to use it.  
The study team may be notified if you receive other health care services at URMC or its 
Affiliates (e.g., visit to the emergency room). In addition, the following individuals may 
know you participated in research and may see results of testing conducted for this 
study: 
• 
Staff at the University of Rochester Medical Center and its Affiliates (e.g., Strong 
Memorial Hospital, Highland Hospital, URMC primary care, specialist physician 
offices) who have a reason to access your electronic health record.  
• 
Individuals who request a copy of information from your health record for 
activities such as treatment or payment (e.g., medical insurance companies, 
worker’s compensation). 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This Web site will not include information that can identify you.  
At most, the Web site will include a summary of the results.  You can search this 
website at any time.  
Reproduction 
The effect of ustekinumab on human sperm or unborn babies is not known. 


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Pregnant women and women who are making breast milk to feed infants cannot 
participate in this study. Female subjects must have a blood test when beginning this 
study that shows they are not pregnant.  
It is very important that women taking part in this study do not become pregnant 
while taking part in this study and for at least 15 weeks after the last dose of 
study drug. If is very important that men taking part in this study do not get a 
woman pregnant while taking part in this study or for at least 15 weeks after the 
last dose of study drug. 
During this study and for at least 15 weeks after the last dose of study drug, women of 
childbearing potential and men with female partners of childbearing potential must use 
proven birth control methods.  Your study doctor will discuss effective birth control 
methods with you. 
If you think that you have become pregnant or may have fathered a child while taking 
part in the study or for 15 weeks after your last dose of study drug, tell your study doctor 
immediately.  You should also notify your childbirth doctor that the mother/ father 
received an experimental drug (Ustekinumab). 
If you are a female study subject and you become pregnant during your participation in 
this study, your treatment with study drug will be stopped and you may be withdrawn 
from some of the study procedures but not from follow-up with your study doctor. The 
study doctor will ask for your permission to stay in contact with you throughout the 
length of the pregnancy.  
If you are a female study subject, you must not donate eggs during the study and for at 
least 15 weeks after your last dose of study drug. 
If you are a male study subject and you father a child during your participation in this 
study or within 15 weeks after your last dose of study drug, you will be asked by the 
study doctor for your partner’s permission to stay in contact with her throughout the 
length of the pregnancy. Your partner will be asked to sign a separate pregnant partner 
consent form. 
If you are a male study subject, you must not donate sperm during the study and for at 
least 15 weeks after your last dose of study drug. 
If you become pregnant or father a child during your participation in this study or during 
15 weeks after your last dose of study drug, your study doctor is required to notify the 
drug manufacturer of the pregnancy. Your study doctor will ask you/ your partner 
questions about the pregnancy such as how many weeks along in the pregnancy is, 
when the expected due date is, and if the pregnancy is a result of birth control failure. 
This information will be shared with the drug manufacturer. We will ask your permission 
to notify the childbirth doctor that you received an investigational drug (ustekinumab). 
We will provide you with information about the drug manufacturer’s pregnancy registry 
that monitors pregnancy outcomes in women that have been exposed to Ustekinumab. 
We will encourage you to enroll in that registry.  


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Within 30 days of the expected due date, a member of the study team will contact you/ 
your partner by telephone to collect information about the outcome of the pregnancy. 
Information collected may include, but is not limited to, the type of delivery, the number 
of weeks of pregnancy at which you/ your partner gave birth, number of fetuses, and 
whether or not an abnormal pregnancy outcome (i.e. spontaneous abortion, stillbirth, 
congenital anomaly, ectopic pregnancy etc.) occurred.   
If you/ your partner experience an abnormal pregnancy outcome from a pregnancy that 
occurred during your participation in this study or during the 15 weeks after your last 
dose of study drug, you should notify your study doctor immediately. Your study doctor 
is required to notify the drug manufacturer of an abnormal pregnancy outcome.   
Benefits of Participation  
You may not benefit from participation in this research study. There is no data on the 
treatment of Sjogren’s Syndrome with ustekinumab. The purpose of this study is to 
determine the safety and effect of ustekinumab on Sjogren’s Syndrome.  
Alternatives to Participation  
Taking part in this research study is voluntary. You do not have to take part in this 
study. Whether or not you take part in this study, you will continue to get regular care 
from your doctor, including receiving standard of care medications for your SS. You may 
also choose to take part in another study. You are encouraged to talk with your regular 
doctor, as well as the study doctor about your choices including the risks and benefits, 
before you decide if you want to take part in this research study. 
Compensation for Injury  
If you are directly injured by the study drug being studied, or by medical procedures 
needed because of this study, and you receive medical care for the injury, you may 
need to pay for that care.  You will be reimbursed for reasonable and necessary medical 
costs for such care, but you might not be reimbursed for care covered and paid for by a 
third party like your health insurance provider, or costs such as required co-payments or 
deductibles related to that coverage.  No other funds have been set aside to pay for 
such things as lost wages or expenses due to a current underlying illness or condition. 
If your research injury is paid for by the University of Rochester, we will collect your 
name, date of birth, gender, and Medicare Health Insurance Claim Number or Social 
Security Number to determine your Medicare status. This information will be used only 
in accordance with the law. If you are a Medicare beneficiary, information about the 
study you are in, and any payments made related to your injury, will be reported to the 
Centers for Medicare & Medicaid Services (CMS), in accordance with CMS 
requirements.  This information will not be used for any other purpose. 
Costs  
You will not be charged for any of the study-related treatments or procedures. The costs 
of the investigational drug, all tests associated with the study, and all scheduled visits 
will be covered by the study. You will not have to pay for parking.  
If you are due to have your blood drawn for your clinical care (i.e. standard of care labs) 
you may be given the option to have those labs drawn at the same time as the research 


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blood for your convenience. The study team will inform you of what labs would be drawn 
standard of care. Since standard of care labs are not part of this research, you and/or 
your health insurance provider will be responsible for paying that cost. This will be 
discussed with you prior to drawing blood and you will have the option to decline.  
Payments  
You will be paid $75 at the end of each completed scheduled visit. You will not be paid 
for unscheduled visits. You will also be given a parking pass if needed for each visit.  
The total possible amount you can be paid is $450.00.   
Payment received for participation in research is considered taxable income.  If you 
receive payment for your participation in studies at the University of Rochester and its 
affiliates of $600.00 or more in any one calendar year, the University is required to 
report this information to the Internal Revenue Service (IRS) in a 1099 (Miscellaneous 
Income) form.  You will be asked to complete a copy of this form and a copy will be sent 
to the IRS.  
We will use your information and/ or samples for research only. However, the results of 
this research might someday lead to the development of products (such as a drug) that 
could be sold by a company. You will not receive any money that may result from any 
commercial tests or products that are developed as a result of this study. 
Confidentiality of Records and Authorization to Use and Disclose Information for 
Research Purposes  
The University of Rochester makes every effort to keep the information collected from 
you private.  In order to do so, we will assign you a study number instead of labeling the 
information we collect from you with your name (or medical record number). 
Sometimes, however, researchers need to share information that may identify you with 
people that work for the University, regulators or the study sponsor.   
If you have never received a copy of the University of Rochester Medical Center 
(URMC) and Affiliates Notice of Privacy Practices, please ask the investigator for one.  
What information may be used and given to others? 
The study doctor will get your personal and medical information.  For example:  
• Research records 
• Records about phone calls made as part of this research 
• Records about your study visits 
• Past and present medical records related to the study   
• Results of medical tests   
Who may use and give out information about you? 
• The study doctor and the study staff 
• URMC and Affiliates 
Your information may be given to:  
• The Department of Health and Human Services  The University of Rochester  
Janssen Scientific Affairs, Inc. 


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• 
Investigators at other collaborating institutions 
• 
The U.S. Food and Drug Administration (FDA) may also need to inspect study 
records at some point during the study or even after it has been completed.  In 
the event that this should occur, every effort will be made to keep identifying 
information about you private.  
• 
Your/ your partner’s childbirth doctor (if applicable) Why will this information be 
used and/or given to others? 
• 
To do the research  
• 
To study the results  
• 
To see if the research was done correctly   
If the results of this study are made public, information that identifies you will not be 
used. 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
May I review or copy my information? 
Yes, but only after the research is over. 
How long will this permission be valid? 
This permission will last indefinitely.  
May I cancel my permission to use and disclose information? 
Yes. You may cancel your permission to use and disclose your health information at any 
time.  You do this by sending written notice to the study doctor.  Upon receiving the written 
notice, the study team will no longer use or disclose your health information and you will 
not be able to stay in this study.  Information that has already been gathered may need to 
be used and given to others for the validity of the study.   
May I withdraw from the study? 
Yes. If you withdraw your permission to be in the study, no new health information 
identifying you will be gathered after that date.  Information that has already been 
gathered may still be used and given to others.   
Is my health information protected after it has been given to others? 
No. There is a risk that your information will be given to others without your permission. 
Future Use of Samples (optional) 
If any of your samples obtained for this study remain after all the tests for this study are 
completed, we would like your permission to preserve and store the remaining samples 
in our secure lab for future research. You will be given the option at the end of this 
consent form to decide if you would like your samples used for future research. You can 
withdraw consent to have your samples stored at any time and can continue to 
participate in this study.  


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We may share some of your leftover study samples, sample data and the clinical 
information we have gathered about you with investigators at other collaborating 
institutions. All identifiers will be removed before your samples/ information are used or 
distributed. Your samples and information will be given a study number. The information 
linking this number to your name and personal information will only be accessible by the 
study coordinators and the Investigators at the University of Rochester. You will not be 
informed of the results of any such future research, nor will you benefit financially from 
any potential new discoveries or technological advances brought about through future 
research using your sample(s). 
Contact for Future Research Studies (optional) 
We are developing a database of individuals who have taken part in our research studies 
and who might be 
interested 
in participating 
in future studies. The database 
is a document 
in which we will store individual’s personal information and medical history. We will use 
the  database  as  a  central  
resource  
to  assist  
in  
recruiting  
interested  subjects  
for  
future 
research studies. If you agree we will store your information in our Repository database. 
Your  personal  information  will  be  stored  indefinitely  in  our  repository  database.  This 
means that we will keep your personal information in our database forever or unless you 
tell us to remove your 
information. If at some future date you no longer want us to contact 
you  using  your  
information  
in  our  database,  you  may  write  us  
to  
request  
that  we  stop 
doing so. 
Circumstances for Dismissal  
You may be withdrawn from the study without your consent at the discretion of 
the Investigator and/or Sponsor for any reason including:  Positive pregnancy 
test 
• If you do not keep appointments for study visits 
• If your disease becomes worse 
• If you develop another disease or serious infection that will interfere with the 
study 
• If your doctor feels that remaining in the study is harmful to your health 
• Termination of funding for the study 
If you are withdrawn from the study, you will be asked to cooperate by having laboratory 
tests and examinations necessary to complete your participation in the study. 
In addition, you will be withdrawn from the study after the screening visit if we learn 
anything during the screening activities that would disqualify you for the study. 
Early Termination  
You may withdraw from the study at any time without loss of benefit or medical care 
which you are entitled to. You are encouraged to contact the study doctor or clinical 
staff should you decide not to continue participation in the study. They will explain the 
best way for you to discontinue your participation in the trial.  You may be asked to be 
seen by the study doctor for an early termination visit.  


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New Study Information 
If we discover any new information that might make you change your mind about 
continuing in the study, we will let you know. 
Funding and Drug Support  
The University of Rochester is receiving payment from Janssen Scientific Affairs, Inc. 
for conducting this research study. 
Return of Research Results  
Subjects with autoimmune diseases have lab tests performed regularly to monitor their 
disease. Standard of care labs drawn during the study visit for subject convenience, will 
be 
included 
in your electronic medical record. Subjects with access to MyChart will receive 
results at the same time as the investigator. 
Your  research  results  will  not  be  available  to  you.  There  is  a  remote  chance  that  a 
previously unknown condition could be discovered while examining your blood sample or 
during clinical assessments. Although unlikely, if this was to occur the study doctor would 
contact you and suggest an appropriate medical referral.   
Contact Persons 
For more information concerning this research or if you feel that your participation has 
resulted in any research related injury, emotional or physical discomfort, please contact: 
Dr. Ummara Shah at (585) 486-0901. 
Please contact the University of Rochester Research Subjects Review Board at 265 
Crittenden Blvd., CU 420628, Rochester, NY 14642, Telephone (585) 276-0005 or 
(877) 449-4441 for the following reasons: 
• You wish to talk to someone other than the research staff about your rights as 
a research subject; 
• To voice concerns about the research; 
• To provide input concerning the research process;  
In the event the 
study staff could not be reached. 
Voluntary Participation 
Taking part in this study is voluntary.  You are free not to take part or to withdraw at any 
time, for whatever reason.  No matter what decision you make, there will be no penalty 
or loss of benefit to which you are entitled.  In the event that you do withdraw from this 
study, the information you have already provided will be kept in a confidential manner. 
CONSENT TO FUTURE USE OF INFORMATION / SAMPLES 
I agree to allow my samples, health information and/or sample data to be stored and 
shared with other researchers for future research? 
Yes  [   ]      No [   ] 


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CONSENT TO RE-CONTACT 
I agree to allow my personal health information to be stored in the division of Allergy, 
Immunology and Rheumatology’s Repository database. The storage of my information 
will allow me to be contacted for future research studies.  
Yes    [   ]    No 
[   ] 
SIGNATURES/DATES  
After reading and discussing the information in this consent form you should 
understand: 
• 
Why this study is being done; 
• 
What will happen during the study; 
• 
Any possible risks and benefits to you; 
• 
Other options you may have instead of being in the study;  
• 
How your personal information will be protected; 
• 
What to do if you have problems or questions about this study. 
Subject Consent 
I have read (or have had read to me) the contents of this consent form and have been 
encouraged to ask questions.  I have received answers to my questions.  I agree to 
participate in this study.  I have received (or will receive) a signed copy of this form for 
my records and future reference. 
 
Subject Name (Printed by Subject) 
 
Signature of Subject 
Date 
Person Obtaining Consent 
I have read this form to the subject and/or the subject has read this form.  I will provide 
the subject with a signed copy of this consent form.  An explanation of the research was 
given and questions from the subject were solicited and answered to the subject’s 
satisfaction.  In my judgment, the subject has demonstrated comprehension of the 
information.  I have given the subject adequate opportunity to read the consent before 
signing. 
 
Name and Title (Print) 
 
Signature of Person Obtaining Consent 
Date