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An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885078
Recruitment Status : Active, not recruiting
First Posted : June 24, 2013
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.

The study provides for 7 years of additional treatment with baricitinib.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Baricitinib Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
Actual Study Start Date : June 27, 2013
Estimated Primary Completion Date : February 14, 2024
Estimated Study Completion Date : March 22, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baricitinib 4 mg

Baricitinib 4 milligrams (mg) administered orally once daily throughout the 84 month treatment period. Placebo administered orally to maintain blind.

Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Drug: Baricitinib
Administered orally
Other Names:
  • LY 3009104
  • INCB 028050

Drug: Placebo
Administered orally

Experimental: Baricitinib 2 mg

Baricitinib 2 mg administered orally once daily throughout the 84 month treatment period. Placebo administered orally to maintain blind.

Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Drug: Baricitinib
Administered orally
Other Names:
  • LY 3009104
  • INCB 028050

Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Number of Participants (pts) with One or More Drug Related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline through 84 Months ]

Secondary Outcome Measures :
  1. Proportion of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20, ACR50, and ACR70 [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  2. Proportion of Pts Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2, DAS28-Erythrocyte Sedimentation Rate (ESR) ≤3.2, DAS28-hsCRP <2.6 and DAS28-ESR <2.6, and ACR/European League Against Rheumatism Remission [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  3. Change from Baseline of Originating Study in Modified Total Sharp Score (mTSS) [ Time Frame: Baseline, Month 12, 24, 36, 48 and 60 ]
  4. Proportion of Participants with mTSS change ≤0 [ Time Frame: Baseline, Months 12, 24, 36, 48 and 60 ]
  5. Change from Baseline of Originating Study in Joint Space Narrowing [ Time Frame: Baseline, Month 12, 24, 36, 48 and 60 ]
  6. Change from Baseline of Originating Study in Duration of Morning Stiffness [ Time Frame: Baseline, Month 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  7. Change from Baseline or Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores [ Time Frame: Baseline, Months 66, 72, 90, 102 and 114 ]
  8. Proportion of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 and ≤2.8 [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  9. Proportion of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 and ≥0.3 [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  10. Change from Baseline in Bone Erosion Score [ Time Frame: Baseline, Month 12, 24, 36, 48, and 60 ]
  11. Healthcare Resource Utilization [ Time Frame: Baseline through Months 66, 72, 90, 102 and 114 ]
  12. Proportion of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 and ≤3.3 [ Time Frame: Months 6, 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  13. Time to Relapse [ Time Frame: Baseline through Month 114 ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (planned start date in August 2014)

Exclusion Criteria:

  • Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
  • Have a known hypersensitivity to baricitinib or any component of this investigational product
  • Had investigational product permanently discontinued at any time during a previous baricitinib study
  • Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
  • Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885078


  Hide Study Locations
Locations
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United States, Arizona
Arizona Arthritis & Rheumatology Research
Glendale, Arizona, United States, 85306
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States, 85202
Sun Valley Arthritis Center, LTD
Peoria, Arizona, United States, 85381
Valley Arthritis Care, LLC
Phoenix, Arizona, United States, 85023
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Valley Endocrine, Fresno
Fresno, California, United States, 93720
Allergy and Rheumatology Medical Clinic Inc
La Jolla, California, United States, 92037
Desert Medical Advances
Palm Desert, California, United States, 92260
Stanford University Hospital
Palo Alto, California, United States, 94304
Pacific Arthritis Center
Santa Maria, California, United States, 93454
Inlande Rheumatology Clinical Trials
Upland, California, United States, 91786
United States, Colorado
Boulder Medical Center
Boulder, Colorado, United States, 80304
Denver Arthritis Center
Denver, Colorado, United States, 80230
United States, Connecticut
Clinical Research Center of CT/NY
Danbury, Connecticut, United States, 06810
New England Research Associates
Trumbull, Connecticut, United States, 06611
United States, Delaware
Delaware Arthritis
Lewes, Delaware, United States, 19958
United States, Florida
Orthopedic Research Institute
Boynton Beach, Florida, United States, 33472
Jeffrey Alper MD Research
Naples, Florida, United States, 34102
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States, 34652
Omega Research Consultants
Orlando, Florida, United States, 32804
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
Arthritis Research of Florida
Palm Harbor, Florida, United States, 34684
West Broward Rheumatology Associates, Inc
Tamarac, Florida, United States, 33321
McIlwain Medical Group
Tampa, Florida, United States, 33613
Tampa Medical Group, P.A.
Tampa, Florida, United States, 33614
United States, Idaho
Intermountain Research Center
Boise, Idaho, United States, 83702
United States, Illinois
Deerbrook Medical Associates
Vernon Hills, Illinois, United States, 60061
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
Diagnostic Rheumatology and Research
Indianapolis, Indiana, United States, 46227
Goldpoint Clinical Research LLC
Indianapolis, Indiana, United States, 46260
United States, Maryland
Klein and Associates MD, PA
Cumberland, Maryland, United States, 21502
United States, Michigan
West Michigan Rheumatology
Grand Rapids, Michigan, United States, 49546
Borgess Rheumatology
Kalamazoo, Michigan, United States, 49009
Advanced Rheumatology
Lansing, Michigan, United States, 48910
Office: Dr. Fiechtner, Justus
Lansing, Michigan, United States, 48910
United States, Mississippi
Arthritis and Osteporosis Treatment and Research Center
Flowood, Mississippi, United States, 39232
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Clayton Medical Research
Saint Louis, Missouri, United States, 63117
Arthritis Consultants
Saint Louis, Missouri, United States, 63141
United States, Nevada
Dr. George Timothy Kelly
Las Vegas, Nevada, United States, 89128
United States, New Jersey
(AOA) Arthritis & Osteoporosis Associates
Freehold, New Jersey, United States, 07728
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States, 87102
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12203
Drug Trials of America
Hartsdale, New York, United States, 10530
Allergy Asthma Immunology of Rochester, AAIR Research Ctr
Rochester, New York, United States, 14618
United States, North Carolina
Asheville Rheumatology & Osteoporosis Research Assoc, PA
Asheville, North Carolina, United States, 28803
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States, 28207
United States, Ohio
Paramount Medical Research
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Health Research Institute
Oklahoma City, Oklahoma, United States, 73103
Healthcare Research Consultant
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
East Penn Rheumatology
Bethlehem, Pennsylvania, United States, 18015
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Arthritis Group
Philadelphia, Pennsylvania, United States, 19152
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Carolina Rheumatology and Neurology Associates
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Pioneer Research Solutions
Cypress, Texas, United States, 77429
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, United States, 79424
Accurate Clinical Research
Nassau Bay, Texas, United States, 77058
Accurate Clinical Research
Webster, Texas, United States, 77598
United States, Virginia
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, United States, 23320
United States, Washington
Kadlec Clinic Rheumatology
Kennewick, Washington, United States, 99336
The Seattle Arthritis Clinic
Seattle, Washington, United States, 98133
Vancouver Clinic
Vancouver, Washington, United States, 98664
United States, Wisconsin
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States, 53132
Argentina
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Bahia Blanca, Argentina, B8000HXM
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Ciudad Autonoma de Buenos Aire, Argentina, C1015ABO
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Ciudad Autonoma de Buenos Aire, Argentina, C1128AAF
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Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
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Ciudad Autonoma de Buenos Aire, Argentina, C1221ADC
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Ciudad Autonoma de Buenos Aire, Argentina, C1417EYG
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Ciudad Autonoma de Buenos Aire, Argentina, C1419AHN
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Ciudad Autonoma de Buenos Aire, Argentina, C1425AGC
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Ciudad Autonoma de Buenos Aire, Argentina, C1426AAL
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Ciudad Autonoma de Buenos Aire, Argentina, C1428DZF
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Ciudad Autonoma de Buenos Aire, Argentina, C1430CKE
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Ciudad Autonoma de Buenos Aire, Argentina, C1431FWO
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Ciudad Autonoma de Buenos Aire, Argentina, C1440AAD
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Cordoba, Argentina, X5004BAK
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Cordoba, Argentina, X5008HHW
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Cordoba, Argentina, X5016KEH
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Córdoba, Argentina, X5000EDC
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Mar del Plata, Argentina, B7600FYK
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Mar Del Plata, Argentina, B7600FZN
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Quilmes, Argentina, B1878DVC
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Quilmes, Argentina, B1878GEG
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Rosario, Argentina, S2000CFJ
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Rosario, Argentina, S2000PBJ
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San Fernando, Argentina, B1646DBM
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San Juan, Argentina, J5402DIL
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San Miguel De Tucuman, Argentina, T4000AXL
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San Miguel de Tucuman, Argentina, T4000BRD
Australia
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Camperdown, Australia, 2050
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Fitzroy, Australia, 3065
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Garran, Australia, 2605
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Kogarah, Australia, 2217
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Malvern East, Australia, 3145
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Maroochydore, Australia, 4558
Austria
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Graz, Austria, 8036
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Wien, Austria, 1100
Belgium
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Brussels, Belgium, 1200
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Merksem, Belgium, 2170
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Mons, Belgium, 7000
Brazil
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Sao Paulo, Brazil, 04032-060
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Sao Paulo, Brazil, 04266-010
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São Paulo, Brazil, 01244-030
Canada
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Edmonton, Canada, T5M 0H4
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Kelowna, Canada, V1Y 4N7
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Kitchener, Canada, N2M 5N6
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Ottawa, Canada, K1H 1A2
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Quebec City, Canada, G1W 4R4
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Saskatoon, Canada, S7K 0H6
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St. Catherines, Canada, L2N 7E4
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Toronto, Canada, M5T 2S8
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Toronto, Canada, M5T 3L9
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Trois-Rivieres, Canada, G8Z 1Y2
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Victoria, Canada, V8V 3M9
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Winnipeg, Canada, R3A 1M3
China
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Beijing, China, 100029
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Beijing, China, 100044
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Bengbu, China, 233004
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Changsha, China, 410008
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Changsha, China, 410011
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Chengdu, China, 610041
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Guangzhou, China, 510080
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Hefei, China, 230001
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Hefei, China, 230022
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Jinan, China, 250012
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Kunming, China, 650032
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Ningbo, China, 315010
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Pingxiang, China, 337055
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Shanghai, China, 200032
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Shanghai, China, 200052
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Shantou, China, 515041
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Tianjin, China, 300052
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Yancheng, China, 224005
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ZhuZhou, China, 412007
Croatia
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Osijek, Croatia, 31000
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Zagreb, Croatia, 10000
Czechia
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Brno, Czechia, 611 41
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Bruntal, Czechia, 792 01
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Hustopece, Czechia, 693 01
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Ostrava - Trebovice, Czechia, 722 00
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Ostrava, Czechia, 702 00
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Pardubice, Czechia, 530 02
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Praha, Czechia, 128 50
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Uherske Hradiste, Czechia, 686 01
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Zlin, Czechia, 760 01
Denmark
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Frederiksberg, Denmark, 2000
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Glostrup, Denmark, 2600
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Odense, Denmark, 5000
France
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Cahors Cedex 9, France, 46005
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Limoges, France, 87042
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Montpellier, France, 34295
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Orleans Cedex 2, France, 45067
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Paris, France, 75651
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Paris, France, 75679
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Poitiers, France, 86021
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Rennes, France, 35056
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Thionville, France, 57100
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Tours, France, 37044
Germany
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Bayreuth, Germany, 95444
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Berlin, Germany, 10117
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Dresden, Germany, 01067
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Gommern, Germany, 39245
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Hamburg, Germany, 22081
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Heidelberg, Germany, 69120
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Köln, Germany, 50937
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Munich, Germany, 80336
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Würzburg, Germany, 97080
Greece
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Athens, Greece, 11527
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Heraklion, Greece, 71110
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Kifissia, Greece, 14561
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Larissa, Greece, 41110
Hungary
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Bekescsaba, Hungary, 5600
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Budapest, Hungary, 1023
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Budapest, Hungary, 1027
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Kiskunhalas, Hungary, 6400
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Nyiregyhaza, Hungary, 4400
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Szekesfehervar, Hungary, 8000
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Veszprem, Hungary, 8200
India
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Ahmedabad, India, 532004
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Attavar, Mangalore, India, 575001
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Bangalore, India, 560034
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Bangalore, India, 560054
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Belgaum, India, 590010
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Gurgaon, India, 122001
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Hyderabad, India, 500020
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Hyderabad, India, 500072
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Jaipur, India, 302006
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Kolkata, India, 700020
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Kolkata, India, 700054
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Lucknow, India, 226018
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New Delhi, India, 110060
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New Delhi, India, 110076
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Secunderabad, India, 500003
Israel
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Ashkelon, Israel, 7830604
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Haifa, Israel, 31048
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Haifa, Israel, 34362
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Haifa, Israel, 3525406
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 4428164
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Petah Tiqva, Israel, 4941492
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Tel Aviv Jaffa, Israel, 6423906
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Zerifin, Israel, 6093000
Italy
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Firenze, Italy, 50139
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Milano, Italy, 20157
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Rome, Italy, 00161
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Torino, Italy, 10154
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Verona, Italy, 37134
Japan
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Arakawa-Ku, Japan, 116-8567
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Asahikawa, Japan, 070-8644
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Asahikawa, Japan, 078-8243
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Chuo-Ku, Japan, 104-8560
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Chuo-ku, Japan, 260-8712
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Fukuoka, Japan, 810-0001
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Fukuoka, Japan, 810-8563
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Fukuoka, Japan, 812-0025
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Fukuoka, Japan, 813-0017
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Fukuoka, Japan, 814-0002
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Hachioji, Japan, 193-0931
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Hamamatsu, Japan, 430-8558
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Hiroshima, Japan, 730-0017
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Hiroshima, Japan, 733-0032
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Hitachi, Japan, 316-0015
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Iizuka, Japan, 820-8505
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Isehara, Japan, 259-1193
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Itabashi-ku, Japan, 173-8610
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Kagoshima, Japan, 891-0133
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Kato, Japan, 673-1462
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Kawagoe, Japan, 350-8550
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Kawaguchi, Japan, 333-0833
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Kawasaki, Japan, 216-8511
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Kirishima, Japan, 899-5117
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Kita-gun, Japan, 761-0793
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Kitakyushu, Japan, 807-8556
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Koshi, Japan, 861-1196
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Kumamoto, Japan, 861-5515
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Kumamoto, Japan, 862-0976
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Kumamoto, Japan, 862-8655
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Matsudo, Japan, 271-0064
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Meguro-Ku, Japan, 152-8902
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Mitaka, Japan, 181-8611
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Morioka, Japan, 020-0015
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Morioka, Japan, 020-0034
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Nagano, Japan, 380-8582
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Nagaoka, Japan, 940-2085
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Nagasaki, Japan, 850-0832
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Nagasaki, Japan, 852-8511
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Nagoya, Japan, 455-8530
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Nagoya, Japan, 460-0001
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Nagoya, Japan, 466-8560
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Narashino, Japan, 275-8580
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Oita, Japan, 870-0823
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Okayama, Japan, 700-0013
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Okayama, Japan, 700-8558
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Okayama, Japan, 700-8607
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Omura, Japan, 856-8562
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Osaka, Japan, 545-0011
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Sapporo, Japan, 060-0001
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Sapporo, Japan, 060-0061
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Sapporo, Japan, 060-8648
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Sapporo, Japan, 063-0811
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Sasebo, Japan, 857-1195
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Sayama, Japan, 350-1305
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Setagaya, Japan, 155-0031
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Setouchi, Japan, 701-4264
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Shibata, Japan, 957-0054
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Shimotsuke, Japan, 329-0498
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Shinjuku-Ku, Japan, 160-8582
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Shizuoka, Japan, 420-0821
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Shizuoka, Japan, 420-8623
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Shunan, Japan, 745-0824
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Takaoka, Japan, 933-0874
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Takarazuka, Japan, 665-0827
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Tokorozawa, Japan, 359-1111
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Tomigusuku, Japan, 901-0243
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Tsukuba, Japan, 305-8576
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Ureshino, Japan, 843-0393
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Yokkaichi, Japan, 510-0016
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Yokohama-City, Japan, 224-0041
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Yokohama, Japan, 222-0036
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Yokohama, Japan, 236-0004
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Yokohama, Japan, 236-0037
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Yotsukaido, Japan, 284-0003
Korea, Republic of
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Daegu, Korea, Republic of, 41944
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Daegu, Korea, Republic of, 42472
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Daejeon, Korea, Republic of, 35015
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Gwangju, Korea, Republic of, 61469
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Incheon, Korea, Republic of, 21565
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Incheon, Korea, Republic of, 22332
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Seoul, Korea, Republic of, 02447
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 04763
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Seoul, Korea, Republic of, 05030
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Seoul, Korea, Republic of, 05278
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06591
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Seoul, Korea, Republic of, 07061
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Seoul, Korea, Republic of, 07345
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Suwon, Korea, Republic of, 16499
Latvia
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Liepaja, Latvia, LV-3401
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Riga, Latvia, LV-1002
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Valmiera, Latvia, LV-4201
Lithuania
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Kaunas, Lithuania, LT-50128
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Klaipeda, Lithuania, LT-92288
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Siauliai, Lithuania, LT-76231
Mexico
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Guadalajara, Mexico, 44160
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Guadalajara, Mexico, 44620
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Guadalajara, Mexico, 44650
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Guadalajara, Mexico, 44690
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Merida, Mexico, 97000
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Merida, Mexico, 97070
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Mexicali, Mexico, 21200
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Mexico City, Mexico, 03100
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Mexico City, Mexico, 06090
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Mexico City, Mexico, 06100
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Mexico City, Mexico, 06700
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Monterrey, Mexico, 64020
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San Luis Potosi, Mexico, 78213
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Tijuana, Mexico, 22010
Netherlands
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Almelo, Netherlands, 7600 SZ
Poland
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Bydgoszcz, Poland, 85-168
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Elblag, Poland, 82-300
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Gdansk, Poland, 80-546
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Katowice, Poland, 40-084
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Lodz, Poland, 90-242
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Nadarzyn, Poland, 05-830
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Warsaw, Poland, 01-518
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Warszawa, Poland, 02-507
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Warszawa, Poland, 02-691
Portugal
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Almada, Portugal, 2805-267
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Lisbon, Portugal, 1050-034
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Ponte De Lima, Portugal, 4990-041
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Porto, Portugal, 4099-001
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Porto, Portugal, 4200-319
Puerto Rico
Office of Dr. Ramon Toro
San German, Puerto Rico, 00683
Mindful Medical Research
San Juan, Puerto Rico, 00918
Barbara Diaz Hernandez
San Juan, Puerto Rico, 00927
Latin Clinical Trial Center
Santurce, Puerto Rico, 00909
Romania
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Bucharest, Romania, 010584
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Bucuresti, Romania, 011172
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Bucuresti, Romania, 020475
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Constanta, Romania, 900591
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Iasi, Romania, 700661
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Targu Mures, Romania, 540136
Russian Federation
Family Clinic #4
Korolev, Russian Federation, 141060
V.A. Nasonova Research Institute of Rheumatology
Moscow, Russian Federation, 115522
City Clinical Hospital #1
Moscow, Russian Federation, 119049
First Moscow State Medical University n.a. I.M.Sechenov
Moscow, Russian Federation, 119992
Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
Ryazan, Russian Federation, 390026
Leningrad Regional Clinical Hospital
Saint Petersburg, Russian Federation, 194291
Saratov Regional Clinical Hospital
Saratov, Russian Federation, 410053
Saint-Petersburg Healthcare Institution "Clinical Rheumatology Hospital #25"
St. Petersburg, Russian Federation, 190068
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russian Federation, 432063
Clinical Hospital for Emergency Care
Yaroslavl, Russian Federation, 150003
Slovakia
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Bratislava, Slovakia, 84231
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Bratislava, Slovakia, 85101
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Partizanske, Slovakia, 95801
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Spisska Nova Ves, Slovakia, 05201
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Topolcany, Slovakia, 95501
Slovenia
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Ljubljana, Slovenia, 1000
South Africa
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Durban, South Africa, 4001
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Durban, South Africa, 4092
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Pinelands, South Africa, 7405
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Port Elizabeth, South Africa, 6057
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Somerset West, South Africa, 7130
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Stellenbosch, South Africa, 7600
Spain
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Barcelona, Spain, 08025
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Barcelona, Spain, 08036
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Bilbao, Spain, 48013
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Getafe, Spain, 28905
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La Vila Joiosa, Spain, 03570
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Sabadell, Spain, 08208
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Santander, Spain, 39008
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Sevilla, Spain, 41010
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Sevilla, Spain, 41071
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Valencia, Spain, 46026
Sweden
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Göteborg, Sweden, 41345
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Malmo, Sweden, 20502
Switzerland
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Fribourg, Switzerland, 1708
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Lausanne, Switzerland, 1011
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Zürich, Switzerland, 8091
Taiwan
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Neihu Taipei, Taiwan, 11490
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Taichung City, Taiwan, 40201
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Taichung, Taiwan, 40447
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Taipei, Taiwan, 10048
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Taipei, Taiwan, 10449
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Taipei, Taiwan, 10630
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Taipei, Taiwan, 11217
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Taoyuan, Taiwan, 33378
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Yongkang City, Taiwan, 71004
Turkey
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Edirne, Turkey, 22030
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Gaziantep, Turkey, 27310
United Kingdom
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Basingstoke, United Kingdom, RG24 9NA
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Bradford, United Kingdom, BD5 0NA
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Cambridge, United Kingdom, CB2 0QQ
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London, United Kingdom, E11 1NR
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London, United Kingdom, SE1 9RT
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North Shields, United Kingdom, NE29 8NH
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Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01885078     History of Changes
Other Study ID Numbers: 14060
I4V-MC-JADY ( Other Identifier: Eli Lilly and Company )
2012-003686-17 ( EudraCT Number )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases