Phase
Condition
Rheumatoid Arthritis
Musculoskeletal Diseases
Bone Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the AmericanCollege of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteriafor the Classification of RA
Have moderately to severely active RA defined as the presence of at least 6/68 tenderjoints and at least 6/66 swollen joints
Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP)measurement ≥ (greater than or equal to) 1 times the upper limit of normal (ULN)
Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:
experienced insufficient efficacy or loss of efficacy
experienced intolerance of such treatment
Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchangingdose for at least 8 weeks prior to study entry
Exclusion
Exclusion Criteria:
Have received a biologic treatment for RA within 28 days of planned randomization;have received rituximab within 6 months of planned randomization
Are currently receiving corticosteroids at doses > (greater than) 10 mg per day ofprednisone (or equivalent) or have been receiving an unstable dosing regimen ofcorticosteroids within 2 weeks of study entry or within 6 weeks of plannedrandomization
Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or havebeen receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry orwithin 6 weeks of planned randomization
Are currently receiving concomitant treatment with methotrexate (MTX),hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
Have received any parenteral corticosteroid administered by intramuscular orintravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks priorto planned randomization or are anticipated to require parenteral injection ofcorticosteroids during the study
Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronicacid within 2 weeks prior to study entry or within 6 weeks prior to plannedrandomization
Have active fibromyalgia that, in the investigator's opinion, would make it difficultto appropriately assess RA activity for the purposes of this study
Have a diagnosis of any systemic inflammatory condition other than RA, such as, butnot limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants withsecondary Sjogren's syndrome are not excluded.)
Have a diagnosis of Felty's syndrome
Have had any major surgery within 8 weeks of study entry or will require major surgeryduring the study that, in the opinion of the investigator in consultation with Lillyor its designee, would pose an unacceptable risk to the participant
Have experienced any of the following within 12 weeks of study entry: myocardialinfarction, unstable ischemic heart disease, stroke, or have New York HeartAssociation stage IV heart failure
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,endocrine, hematological, neurological, or neuropsychiatric disorders or any otherserious and/or unstable illness that, in the opinion of the investigator, couldconstitute a risk when taking investigational product or could interfere with theinterpretation of data
Are largely or wholly incapacitated permitting little or no self care, such as, beingbedridden or confined to a wheelchair
Have an estimated glomerular filtration rate (eGFR) based on the most recent availableserum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
Have a history of chronic liver disease with the most recent available aspartateaminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or themost recent available total bilirubin ≥1.5 times the ULN
Have a history of, lymphoproliferative disease; or have signs or symptoms suggestiveof possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; orhave active primary or recurrent malignant disease; or have been in remission fromclinically significant malignancy for <5 years
Have been exposed to a live vaccine within 12 weeks prior to planned randomization orare expected to need/receive a live vaccine during the course of the study (with theexception of herpes zoster vaccination)
Have a current or recent clinically serious viral, bacterial, fungal, or parasiticinfection
Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
Have a history of disseminated/complicated herpes zoster (eg, multidermatomalinvolvement, ophthalmic zoster, central nervous system involvement, postherpeticneuralgia)
Are immunocompromised and, in the opinion of the investigator, are at an unacceptablerisk for participating in the study
Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV)
Have screening laboratory test values, including thyroid-stimulating hormone (TSH),outside the reference range for the population or investigative site that, in theopinion of the investigator, pose an unacceptable risk for the participant'sparticipation in the study
Have screening electrocardiogram (ECG) abnormalities that, in the opinion of theinvestigator or the sponsor, are clinically significant and indicate an unacceptablerisk for the participant's participation in the study (e.g. Fridericia's corrected QTinterval >500 millisecond [msec])
Have symptomatic herpes simplex at the time of study enrollment
Have evidence of active or latent tuberculosis (TB)
Study Design
Connect with a study center
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Bahia Blanca, B8000HXM
ArgentinaSite Not Available
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Buenos Aires, C1015ABO
ArgentinaSite Not Available
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Mar Del Plata, B7600FZN
ArgentinaSite Not Available
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Rosario, 2000
ArgentinaSite Not Available
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San Miguel De Tucuman, T4000AXL
ArgentinaSite Not Available
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Tucuman, 4000
ArgentinaSite Not Available
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Garran, Australian Capital Territory 2605
AustraliaSite Not Available
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Camperdown, New South Wales 2050
AustraliaSite Not Available
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Kogarah, New South Wales 04266-010
AustraliaSite Not Available
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Maroochydore, Queensland 4558
AustraliaSite Not Available
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Fitzroy, Victoria 3065
AustraliaSite Not Available
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Graz, 8036
AustriaSite Not Available
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Stockerau, 2000
AustriaSite Not Available
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Vienna, 1100
AustriaSite Not Available
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Brussels, 1000
BelgiumSite Not Available
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Liège, 4000
BelgiumSite Not Available
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Mons, 7000
BelgiumSite Not Available
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Winnipeg, Manitoba R3N 0K6
CanadaSite Not Available
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Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
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Mississauga, Ontario L5M-2V8
CanadaSite Not Available
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Toronto, Ontario M5T 3L9
CanadaSite Not Available
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Quebec City, Quebec G1W 4R4
CanadaSite Not Available
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Saskatoon, Saskatchewan S7K 0H6
CanadaSite Not Available
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Osijek, 31000
CroatiaSite Not Available
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Zagreb, 10000
CroatiaSite Not Available
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Frederiksberg, 2000
DenmarkSite Not Available
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Glostrup, 2600
DenmarkSite Not Available
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Odense, 5000
DenmarkSite Not Available
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Montpellier, 34295
FranceSite Not Available
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Orleans, 45032
FranceSite Not Available
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Paris, 75679
FranceSite Not Available
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Poitiers, 86021
FranceSite Not Available
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Rennes, 35056
FranceSite Not Available
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Rouen, 76031
FranceSite Not Available
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Tours, 3700
FranceSite Not Available
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Berlin, 13125
GermanySite Not Available
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Dresden, 01067
GermanySite Not Available
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Hamburg, 22081
GermanySite Not Available
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Heidelberg, 69120
GermanySite Not Available
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Hildesheim, 31134
GermanySite Not Available
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Würzburg, 97080
GermanySite Not Available
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Athens, 11527
GreeceSite Not Available
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Heraklion, 71110
GreeceSite Not Available
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Kifissia, 14561
GreeceSite Not Available
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Larissa, 411 10
GreeceSite Not Available
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Thessaloniki, 54639
GreeceSite Not Available
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Ahmedabad, 532004
IndiaSite Not Available
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Attavar, Mangalore, 575001
IndiaSite Not Available
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Bangalore, 560 054
IndiaSite Not Available
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Gurgaon, 122001
IndiaSite Not Available
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Hyderabaad, 500082
IndiaSite Not Available
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Jaipur, 302015
IndiaSite Not Available
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Kochin, 682026
IndiaSite Not Available
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Kolkata, 700 020
IndiaSite Not Available
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Mumbai, 400053
IndiaSite Not Available
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New Delhi, 110 076
IndiaSite Not Available
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Secunderabad, 500 003
IndiaSite Not Available
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Afula, 18101
IsraelSite Not Available
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Ashkelon, 78278
IsraelSite Not Available
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Beer Yaakov, 70300
IsraelSite Not Available
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Haifa, 34362
IsraelSite Not Available
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Jerusalem, 91120
IsraelSite Not Available
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Kfar Saba, 44281
IsraelSite Not Available
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Petah Tikva, 49100
IsraelSite Not Available
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Tel Aviv, 64239
IsraelSite Not Available
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Firenze, 50134
ItalySite Not Available
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Milano, 20122
ItalySite Not Available
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Pisa, 56100
ItalySite Not Available
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Rome, 00100
ItalySite Not Available
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Chiba, 284-0003
JapanSite Not Available
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Fukuoka, 810-8563
JapanSite Not Available
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Hiroshima, 730-0017
JapanSite Not Available
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Hokkaido, 060-8648
JapanSite Not Available
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Hyogo, 673-1462
JapanSite Not Available
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Japan, 275-8580
JapanSite Not Available
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Kagawa, 761-0793
JapanSite Not Available
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Kumamoto, 861-1196
JapanSite Not Available
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Nagasaki, 856-8562
JapanSite Not Available
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Okayama, 700-8607
JapanSite Not Available
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Saitama, 359-1111
JapanSite Not Available
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Tokyo, 104-8560
JapanSite Not Available
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Daejeon, 302-799
Korea, Republic ofSite Not Available
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Seoul, 110-744
Korea, Republic ofSite Not Available
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Chihuahua, 06090
MexicoSite Not Available
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Guadalajara, 44650
MexicoSite Not Available
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Mexico City, 06090
MexicoSite Not Available
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Monterrey, 64040
MexicoSite Not Available
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San Luis Potosi, 78213
MexicoSite Not Available
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Almelo, 7609 PP
NetherlandsSite Not Available
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Amsterdam, 1075 HN
NetherlandsSite Not Available
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Nijmegen, 6500 HB
NetherlandsSite Not Available
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Ubbergen, 6574 NA
NetherlandsSite Not Available
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Bydgoszcz, 85-168
PolandSite Not Available
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Gdansk, 80-546
PolandSite Not Available
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Nadarzyn, 05-830
PolandSite Not Available
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Warsaw, 02-507
PolandSite Not Available
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Caguas, 00725
Puerto RicoSite Not Available
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San Juan, 00927
Puerto RicoSite Not Available
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Santurce, 00909
Puerto RicoSite Not Available
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Barcelona, 08025
SpainSite Not Available
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Bilbao, 48013
SpainSite Not Available
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Bilboa, 48013
SpainSite Not Available
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La Vila Joiosa, 03570
SpainSite Not Available
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Santander, 39008
SpainSite Not Available
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Sevilla, 41010
SpainSite Not Available
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Valencia, 46026
SpainSite Not Available
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Villajoyosa, 03570
SpainSite Not Available
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Fribourg, 1708
SwitzerlandSite Not Available
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Lausanne, CH-1011
SwitzerlandSite Not Available
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Villars-Sur-Glâne, 1752
SwitzerlandSite Not Available
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Zürich, 8091
SwitzerlandSite Not Available
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Adana, 1330
TurkeySite Not Available
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Ankara, 06100
TurkeySite Not Available
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Antalya, 07070
TurkeySite Not Available
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Denizli, 06111
TurkeySite Not Available
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Edirne, 22030
TurkeySite Not Available
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Eskisehir, 26480
TurkeySite Not Available
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Gaziantep, 27310
TurkeySite Not Available
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Istanbul, 34303
TurkeySite Not Available
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Manisa, 45030
TurkeySite Not Available
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Torquay, Cnwll TQ2 7AA
United KingdomSite Not Available
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London, Greater London E11 1NR
United KingdomSite Not Available
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North Shields, Tyneside NE29 8NH
United KingdomSite Not Available
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Bradford, West Yorkshire BD5 0NA
United KingdomSite Not Available
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Glendale, Arizona 85304
United StatesSite Not Available
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Peoria, Arizona 85381
United StatesSite Not Available
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Phoenix, Arizona 85023
United StatesSite Not Available
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Tucson, Arizona 85724
United StatesSite Not Available
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Fresno, California 93720
United StatesSite Not Available
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Palo Alto, California 94304
United StatesSite Not Available
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Upland, California 91786
United StatesSite Not Available
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Aurora, Colorado 80045
United StatesSite Not Available
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Denver, Colorado 80230
United StatesSite Not Available
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Longmont, Colorado 80501
United StatesSite Not Available
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Danbury, Connecticut 06810
United StatesSite Not Available
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Trumbull, Connecticut 06611
United StatesSite Not Available
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Lewes, Delaware 19958
United StatesSite Not Available
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Boynton Beach, Florida 33472
United StatesSite Not Available
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Naples, Florida 34102
United StatesSite Not Available
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Orlando, Florida 32806
United StatesSite Not Available
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Tamarac, Florida 33321
United StatesSite Not Available
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Tampa, Florida 33613
United StatesSite Not Available
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Boise, Idaho 83702
United StatesSite Not Available
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Indianapolis, Indiana 46260
United StatesSite Not Available
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Prairie Village, Kansas 66206
United StatesSite Not Available
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Grand Rapids, Michigan 49546
United StatesSite Not Available
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Kalamazoo, Michigan 48025
United StatesSite Not Available
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Lansing, Michigan 48910
United StatesSite Not Available
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Saint Louis, Missouri 63117
United StatesSite Not Available
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St Louis, Missouri 63117
United StatesSite Not Available
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Freehold, New Jersey 07728
United StatesSite Not Available
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Albany, New York 12206
United StatesSite Not Available
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Hartsdale, New York 10530
United StatesSite Not Available
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Rochester, New York 14618
United StatesSite Not Available
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Cincinnati, Ohio 45267
United StatesSite Not Available
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Columbus, Ohio 43210
United StatesSite Not Available
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Oklahoma City, Oklahoma 73103
United StatesSite Not Available
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Tulsa, Oklahoma 74135
United StatesSite Not Available
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Portland, Oregon 97239
United StatesSite Not Available
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Bethlehem, Pennsylvania 18017
United StatesSite Not Available
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Philadelphia, Pennsylvania 19152
United StatesSite Not Available
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Wyomissing, Pennsylvania 19610
United StatesSite Not Available
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Myrtle Beach, South Carolina 29572
United StatesSite Not Available
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Houston, Texas 77008
United StatesSite Not Available
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Lubbock, Texas 79424
United StatesSite Not Available
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Nassau Bay, Texas 77058
United StatesSite Not Available
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Webster, Texas 77508
United StatesSite Not Available
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Chesapeake, Virginia 23320
United StatesSite Not Available
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Kennewick, Washington 99336
United StatesSite Not Available
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Seattle, Washington 98133
United StatesSite Not Available
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Vancouver, Washington 98664
United StatesSite Not Available
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Franklin, Wisconsin 53132
United StatesSite Not Available
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