A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

Last updated: May 11, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01194414
WA22762
2010-018375-22
  • Ages > 18
  • All Genders

Study Summary

This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants, ≥ 18 years of age

  • Rheumatoid arthritis of ≥ 6 months duration, according to American College ofRheumatology (ACR) criteria

  • Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 jointcount) at screening and baseline

  • Inadequate response to current DMARD therapy

  • Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline

  • Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximumrecommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

Exclusion

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following randomization

  • Rheumatic autoimmune disease other than RA

  • Functional class IV (ACR classification)

  • Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16

  • Prior history of or current inflammatory joint disease other than RA

  • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

  • Previous treatment with tocilizumab

  • Active current or history of recurrent infection

Study Design

Total Participants: 1262
Study Start date:
September 01, 2010
Estimated Completion Date:
August 31, 2013

Connect with a study center

  • Buenos Aires, B1878DVB
    Argentina

    Site Not Available

  • Rosario, S2000PBJ
    Argentina

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  • Adelaide, 5011
    Australia

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  • Clayton, 3168
    Australia

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  • Geelong, 3220
    Australia

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  • Hobart, 7000
    Australia

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  • Malvern East, 3145
    Australia

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  • Maroochydore, 4558
    Australia

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  • New Lambton, 2305
    Australia

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    Newcastle, 2305
    Australia

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    Woodville, 5011
    Australia

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  • Curitiba, 80060-240
    Brazil

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  • Goiania, 74110010
    Brazil

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  • Juiz de Fora, 36010-570
    Brazil

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  • Porto Alegre, 90610-000
    Brazil

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  • Sao Paulo, 4037003
    Brazil

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    São Paulo, 05403-000
    Brazil

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  • São Paulo, 05403-000
    Brazil

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  • Sofia, 1606
    Bulgaria

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  • Edmonton, Alberta T5H 3V9
    Canada

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  • Kelowna, British Columbia V1Y 3G8
    Canada

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  • Vancouver, British Columbia V5Z 1L7
    Canada

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  • St John's, Newfoundland and Labrador A1A 5E8
    Canada

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  • Hamilton, Ontario L8N 1Y2
    Canada

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  • Kitchener, Ontario N2M 5N6
    Canada

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  • Ottawa, Ontario K1Y 4G2
    Canada

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  • St. Catharines, Ontario L2N 7E4
    Canada

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  • Windsor, Ontario N8X 5A6
    Canada

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  • Montreal, Quebec H2L 1S6
    Canada

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  • Quebec City, Quebec G1V 3M7
    Canada

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  • Rimouski, Quebec G5L 3W1
    Canada

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  • Sainte-foy, Quebec G1W 4R4
    Canada

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  • Trois-rivieres, Quebec G8Z 1Y2
    Canada

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  • Saskatoon, Saskatchewan S7K 0H6
    Canada

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  • Barranquilla,
    Colombia

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    Colombia

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    Bogotá,
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  • Bordeaux, 33076
    France

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  • Le Mans, 72037
    France

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  • Marseille, 13285
    France

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  • Montpellier, 34295
    France

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  • Nantes, 44035
    France

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  • Paris, 75679
    France

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  • Strasbourg, 67098
    France

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  • Toulouse, 31059
    France

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  • Bad Bramstedt, 24576
    Germany

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  • Berlin, 10117
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  • Essen, 45239
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  • Freiburg, 79106
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  • Gommern, 39245
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    Köln, 50924
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    Osnabrück, 49074
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    Würzburg, 97080
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    Guatemala

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    Italy

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    Ferrara, 44100
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    Roma, 00168
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  • Klaipeda, 92288
    Lithuania

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  • Siauliai, 76231
    Lithuania

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  • Vilnius, LT-08661
    Lithuania

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  • Culiacan, 80000
    Mexico

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    Mexico

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    Mexico, 44620
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  • Mexico Ctiy, 07760
    Mexico

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  • Morelia, 58070
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  • Obregon, 85000
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  • Queretaro, 76178
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    Mexico

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  • Auckland, 2025
    New Zealand

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    New Zealand

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  • Wellington, 6035
    New Zealand

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    Peru

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    Quezon City, 1102
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  • Warszawa, 01-157
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  • Ponce, 00716
    Puerto Rico

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  • Bucharest, 011172
    Romania

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    Romania

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  • Iasi, 700661
    Romania

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    Ekaterinburg, 620102
    Russian Federation

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  • Moscow, 119991
    Russian Federation

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  • Novosibirsk, 630099
    Russian Federation

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  • Ryazan, 390026
    Russian Federation

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    Saratov, 410002
    Russian Federation

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  • St Petersburg, 190068
    Russian Federation

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    Tula, 300053
    Russian Federation

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  • Ulyanovsk, 432600
    Russian Federation

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  • Yaroslavl, 150030
    Russian Federation

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  • Singapore, 119074
    Singapore

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  • Cape Town, 7500
    South Africa

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  • Durban, 4001
    South Africa

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  • Parktown, 2000
    South Africa

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  • Port Elizabeth, 6045
    South Africa

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  • Stellenbosch, 7600
    South Africa

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  • Barakaldo, 48903
    Spain

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  • Bilbao, 48013
    Spain

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  • La Coruna, 15006
    Spain

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  • La Laguna, 38320
    Spain

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  • Madrid, 28007
    Spain

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  • Malaga, 29010
    Spain

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  • Merida, 97500
    Spain

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  • Santander, 39008
    Spain

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  • Santiago de Compostela, 15706
    Spain

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  • Sevilla, 41009
    Spain

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  • Torrelavega, 39300
    Spain

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  • Valencia, 46009
    Spain

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  • Bangkok, 10400
    Thailand

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  • Chiang Mai, 50200
    Thailand

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  • Khon Kaen, 40002
    Thailand

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  • Cambridge, CB2 2QQ
    United Kingdom

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  • Cannock, WS11 5XY
    United Kingdom

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  • Coventry, CV2 2DX
    United Kingdom

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  • Eastbourne, BN21 2UD
    United Kingdom

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  • Exeter, EX2 5DW
    United Kingdom

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  • Harrogate, HG2 7SX
    United Kingdom

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  • Ipswich, IP4 5PD
    United Kingdom

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  • London, E11 1NR
    United Kingdom

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  • Middlesborough, TS4 3BW
    United Kingdom

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  • Newcastle Upon Tyne, NE7 7DN
    United Kingdom

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  • Northampton, NN1 5BD
    United Kingdom

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  • Nottingham, NG7 2UH
    United Kingdom

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  • Westcliffe-on-sea, SS0 0RY
    United Kingdom

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  • Wirral, CH49 5PE
    United Kingdom

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  • Huntsville, Alabama 35801
    United States

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  • Tuscaloosa, Alabama 35406
    United States

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  • Tucson, Arizona 85704
    United States

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  • Long Beach, California 90806
    United States

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  • Los Angeles, California 90048
    United States

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  • Upland, California 91786
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  • Van Nuys, California 91405
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    Whittier, California 90606
    United States

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  • Denver, Colorado 80230-7127
    United States

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  • Bridgeport, Connecticut 06606
    United States

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  • Delray Beach, Florida 33484
    United States

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  • Miami, Florida 33133
    United States

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  • Ocala, Florida 34474
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  • Orlando, Florida 32806
    United States

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  • Palm Harbor, Florida 34684
    United States

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  • Pinellas Park, Florida 33782
    United States

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  • South Miami, Florida 33143
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  • Tampa, Florida 33614
    United States

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  • Coeur D'alene, Idaho 83814
    United States

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  • Morton Grove, Illinois 60053
    United States

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  • Wichita, Kansas 67208
    United States

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  • Monroe, Louisiana 71203
    United States

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    Worcester, Massachusetts 01605
    United States

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  • Petoskey, Michigan 49770
    United States

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  • St. Claire Shores, Michigan 48081
    United States

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  • Eagan, Minnesota 55121
    United States

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  • Florissant, Missouri 63031
    United States

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  • Saint Louis, Missouri 63117
    United States

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    St Louis, Missouri 63131
    United States

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  • Lebanon, New Hampshire 03756
    United States

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  • Clifton, New Jersey 07012
    United States

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    Freehold, New Jersey 07728
    United States

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  • Manalapan, New Jersey 07726
    United States

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    Passaic, New Jersey 07055
    United States

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  • Voorhees, New Jersey 08043
    United States

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  • Albuquerque, New Mexico 87102
    United States

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  • Albany, New York 12206
    United States

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  • Binghamton, New York 13905
    United States

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  • Orchard Park, New York 14127
    United States

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  • Asheville, North Carolina 28803
    United States

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  • Raleigh, North Carolina 27609
    United States

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  • Wilmington, North Carolina 28401
    United States

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  • Cincinnati, Ohio 45219
    United States

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  • Toledo, Ohio 43623
    United States

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  • Oklahoma City, Oklahoma 73103
    United States

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  • Tulsa, Oklahoma 74135
    United States

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  • Bethlehem, Pennsylvania 18015
    United States

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  • Charleston, South Carolina 29406
    United States

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  • Knoxville, Tennessee 37909
    United States

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  • Memphis, Tennessee 38119
    United States

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  • Houston, Texas 77004
    United States

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  • San Antonio, Texas 78217
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  • Olympia, Washington 98502
    United States

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  • Seattle, Washington 98122
    United States

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  • Spokane, Washington 99204
    United States

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  • Wenatchee, Washington 98801
    United States

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