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Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

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: NCT01146652
Recruitment Status : Active, not recruiting
First Posted : June 17, 2010
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

Assess the long term safety of sarilumab in patients with rheumatoid arthritis.

Secondary Objective:

Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: SAR153191 (REGN88) Phase 3

Detailed Description:

The maximum duration of the study may be up to 523 weeks:

  • Up to 1-week of screening, if any
  • At least 264 weeks of open label treatment phase and up to 516 weeks as maximum
  • 6-week post-treatment follow-up as required per protocol.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Actual Study Start Date : June 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Extension study
Sarilumab (SAR153191), Disease Modifying Anti-Rheumatic Drug (DMARD) therapy as required in the initial protocol.
Drug: SAR153191 (REGN88)

Pharmaceutical form: solution

Route of administration: subcutaneous





Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]

Secondary Outcome Measures :
  1. Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) [ Time Frame: Up to 264 weeks ]
  2. Disease Activity Score (DAS28-CRP) [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]
  3. European League Against Rheumatism (EULAR) response [ Time Frame: At least 264 weeks or until commercial availability whichever later but no later than 2020 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion criteria :

Patients with Rheumatoid Arthritis (RA) who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, or EFC13752 study.

Exclusion criteria:

Patients with any adverse event leading to permanent study drug discontinuation from a prior study.

Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT01146652


  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840070
Anniston, Alabama, United States, 36207
Investigational Site Number 840138
Birmingham, Alabama, United States, 35205
Investigational Site Number 840152
Huntsville, Alabama, United States, 35801
United States, Arizona
Investigational Site Number 840072
Gilbert, Arizona, United States, 85234
Investigational Site Number 840141
Glendale, Arizona, United States, 85304
United States, California
Investigational Site Number 840134
Fullerton, California, United States, 92835
Investigational Site Number 840008
La Jolla, California, United States, 92093
Investigational Site Number 840135
San Diego, California, United States, 92120
Investigational Site Number 840021
Santa Maria, California, United States, 94354
Investigational Site Number 840100
Stanford, California, United States, 94305
Investigational Site Number 840049
Upland, California, United States, 91786
United States, Colorado
Investigational Site Number 840151
Colorado Springs, Colorado, United States, 80903
United States, Delaware
Investigational Site Number 840130
Lewes, Delaware, United States, 19958
United States, Florida
Investigational Site Number 840153
Aventura, Florida, United States, 33180
Investigational Site Number 840050
Clearwater, Florida, United States, 35765
Investigational Site Number 840033
Fort Lauderdale, Florida, United States, 33309
Investigational Site Number 840041
Gainesville, Florida, United States, 32608
Investigational Site Number 840067
Jupiter, Florida, United States, 33458
Investigational Site Number 840048
Miami, Florida, United States, 33155
Investigational Site Number 840024
Naples, Florida, United States, 34102
Investigational Site Number 840006
Orlando, Florida, United States, 32806
Investigational Site Number 840128
Ormond Beach, Florida, United States, 32174
Investigational Site Number 840063
Palm Harbor, Florida, United States, 34684
Investigational Site Number 840155
Palm Harbor, Florida, United States, 34684
Investigational Site Number 840060
Sarasota, Florida, United States, 34239
Investigational Site Number 840140
Tampa, Florida, United States, 33614
Investigational Site Number 840126
Vero Beach, Florida, United States, 32960
United States, Georgia
Investigational Site Number 840003
Atlanta, Georgia, United States, 30322
Investigational Site Number 840028
Decatur, Georgia, United States, 30033
Investigational Site Number 840027
Marietta, Georgia, United States, 30060
United States, Idaho
Investigational Site Number 840018
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site Number 840046
Chicago, Illinois, United States, 60612
United States, Kansas
Investigational Site Number 840052
Kansas City, Kansas, United States, 66160-7321
United States, Kentucky
Investigational Site Number 840230
Elizabethtown, Kentucky, United States, 42701
Investigational Site Number 840015
Lexington, Kentucky, United States, 40504
United States, Louisiana
Investigational Site Number 840120
Baton Rouge, Louisiana, United States, 70809
Investigational Site Number 840109
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Investigational Site Number 840055
Frederick, Maryland, United States, 21702
Investigational Site Number 840013
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Investigational Site Number 840154
Boston, Massachusetts, United States, 02115
United States, Michigan
Investigational Site Number 840150
Lansing, Michigan, United States, 48910
Investigational Site Number 840137
Saint Clair Shores, Michigan, United States, 48081
United States, Nebraska
Investigational Site Number 840112
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Investigational Site Number 840026
Freehold, New Jersey, United States, 07728
United States, New York
Investigational Site Number 840115
Lake Success, New York, United States, 11042
Investigational Site Number 840056
New York, New York, United States, 10003
Investigational Site Number 840043
New York, New York, United States, 11201
Investigational Site Number 840106
Orchard Park, New York, United States, 14127
Investigational Site Number 840118
Smithtown, New York, United States, 11787
United States, North Carolina
Investigational Site Number 840116
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Investigational Site Number 840233
Minot, North Dakota, United States, 58701
United States, Oklahoma
Investigational Site Number 840002
Oklahoma City, Oklahoma, United States, 73103
Investigational Site Number 840127
Oklahoma City, Oklahoma, United States, 73103
Investigational Site Number 840011
Tulsa, Oklahoma, United States, 74104
Investigational Site Number 840065
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Investigational Site Number 840010
Bethlehem, Pennsylvania, United States, 18015
Investigational Site Number 840009
Duncansville, Pennsylvania, United States, 16635
Investigational Site Number 840062
Reading, Pennsylvania, United States, 19611
United States, South Carolina
Investigational Site Number 840058
Columbia, South Carolina, United States, 29204
Investigational Site Number 840016
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Investigational Site Number 840025
Jackson, Tennessee, United States, 38305
Investigational Site Number 840059
Memphis, Tennessee, United States, 38119
United States, Texas
Investigational Site Number 840032
Amarillo, Texas, United States, 79124
Investigational Site Number 840038
Austin, Texas, United States, 78705
Investigational Site Number 840001
Dallas, Texas, United States, 75231
Investigational Site Number 840022
Dallas, Texas, United States, 75235
Investigational Site Number 840012
Dallas, Texas, United States, 75390
Investigational Site Number 840129
Houston, Texas, United States, 77074
Investigational Site Number 840069
Lubbock, Texas, United States, 79424
Investigational Site Number 840074
Mesquite, Texas, United States, 75150
Investigational Site Number 840020
Nassau Bay, Texas, United States, 77058
Investigational Site Number 840103
San Antonio, Texas, United States, 78217
United States, Washington
Investigational Site Number 840036
Spokane, Washington, United States, 99204
Investigational Site Number 840061
Tacoma, Washington, United States, 98405
United States, West Virginia
Investigational Site Number 840124
Clarksburg, West Virginia, United States, 26301
Argentina
Investigational Site Number 032006
Caba, Argentina, C1015ABO
Investigational Site Number 032007
Caba, Argentina, C1055AAF
Investigational Site Number 032008
Caba, Argentina, C1428DZF
Investigational Site Number 032019
Capital Federal, Argentina, 1180
Investigational Site Number 032016
Capital Federal, Argentina, 1425
Investigational Site Number 032002
Cordoba, Argentina, X5004BAL
Investigational Site Number 032020
Cordoba, Argentina, X5016KEH
Investigational Site Number 032003
Córdoba, Argentina
Investigational Site Number 032017
La Plata, Argentina, B1902
Investigational Site Number 032012
Mar Del Plata, Argentina, B7600FZN
Investigational Site Number 032011
Quilmes, Argentina, B1878DVB
Investigational Site Number 032010
Ramos Mejia, Argentina, B1704ETD
Investigational Site Number 032001
Rosario, Argentina, 2000
Investigational Site Number 032013
Rosario, Argentina, S2000PBJ
Investigational Site Number 032015
San Fernando, Argentina, 1646
Investigational Site Number 032005
San Miguel De Tucuman, Argentina, 4000
Investigational Site Number 032004
San Miguel De Tucuman, Argentina, T4000AXL
Investigational Site Number 032009
Zarate, Argentina, B2800DGH
Australia
Investigational Site Number 036003
Camperdown, Australia, 2050
Investigational Site Number 036012
Fitzroy, Australia, 3065
Investigational Site Number 036010
Garran, Australia, 2605
Investigational Site Number 036004
Heidelberg West, Australia, 3081
Investigational Site Number 036001
Maroochydore, Australia, 4558
Investigational Site Number 036014
Victoria Park, Australia, 6100
Investigational Site Number 036007
Woodville, Australia, 5011
Austria
Investigational Site Number 040001
Graz, Austria, 8036
Belarus
Investigational Site Number 112002
Minsk, Belarus, 220037
Investigational Site Number 112001
Minsk, Belarus, 220116
Belgium
Investigational Site Number 056010
Leuven, Belgium, 3000
Brazil
Investigational Site Number 076001
Curitiba, Brazil, 80060-240
Investigational Site Number 076006
Goiania, Brazil, 74110-120
Investigational Site Number 076010
Juiz De Fora, Brazil, 36010-570
Investigational Site Number 076004
Porto Alegre, Brazil, 90610-000
Investigational Site Number 076005
Rio De Janeiro, Brazil, 20551-030
Investigational Site Number 076015
Rio De Janeiro, Brazil, 22271-100
Investigational Site Number 076011
Salvador, Brazil, 40050-410
Investigational Site Number 076002
Sao Paulo, Brazil, 04039-901
Investigational Site Number 076003
Sao Paulo, Brazil, 04266-010
Investigational Site Number 076013
Vitoria, Brazil, 29055 450
Canada
Investigational Site Number 124003
Mississauga, Canada, L5M 2V8
Investigational Site Number 124002
St. Catharines, Canada, L2N 7E4
Investigational Site Number 124005
Toronto, Canada, M5T 2S8
Investigational Site Number 124009
Trois-Rivières, Canada, G8Z 1Y2
Investigational Site Number 124104
Victoria, Canada, V8V 3P9
Investigational Site Number 124012
Winnipeg, Canada, R3A 1M3
Chile
Investigational Site Number 152005
Osorno, Chile, 5311092
Investigational Site Number 152012
Santiago, Chile, 7500922
Investigational Site Number 152002
Santiago, Chile, 7501126
Investigational Site Number 152011
Santiago, Chile, 7510186
Investigational Site Number 152009
Santiago, Chile, 8207257
Investigational Site Number 152001
Santiago, Chile, 8360156
Investigational Site Number 152013
Santiago, Chile, 8360156
Investigational Site Number 152008
Santiago, Chile
Investigational Site Number 152014
Talca, Chile
Investigational Site Number 152015
Temuco IX Region, Chile, 4790928
Investigational Site Number 152004
Valdivia, Chile, 5090146
Investigational Site Number 152006
Vina Del Mar, Chile
Investigational Site Number 152007
Viña Del Mar, Chile, 2520997
Colombia
Investigational Site Number 170005
Barranquilla, Colombia, 080020399
Investigational Site Number 170004
Barranquilla, Colombia, 99999
Investigational Site Number 170001
Bogota, Colombia, 110221042
Investigational Site Number 170008
Bogota, Colombia, 111211626
Investigational Site Number 170006
Bogotá, Colombia, 11011
Investigational Site Number 170003
Bogotá, Colombia, 111211191
Investigational Site Number 170007
Bucaramanga, Colombia, 680003288
Investigational Site Number 170009
Bucaramanga, Colombia, 680003
Czechia
Investigational Site Number 203009
Liberec, Czechia, 46063
Investigational Site Number 203004
Ostrava, Czechia, 702 00
Investigational Site Number 203034
Pardubice, Czechia, 53002
Investigational Site Number 203001
Praha 2, Czechia, 12850
Investigational Site Number 203007
Praha 2, Czechia, 12850
Investigational Site Number 203011
Praha 2, Czechia, 12850
Investigational Site Number 203010
Praha 4, Czechia, 140 00
Investigational Site Number 203002
Uherske Hradiste, Czechia, 686 01
Investigational Site Number 203006
Zlin, Czechia, 760 01
Ecuador
Investigational Site Number 218003
Cuenca, Ecuador, 010204
Investigational Site Number 218001
Guayaquil, Ecuador, 090109
Investigational Site Number 218002
Quito, Ecuador, 170524
Estonia
Investigational Site Number 233001
Tallinn, Estonia, 10128
Investigational Site Number 233010
Tallinn, Estonia, 10138
Investigational Site Number 233002
Tallinn, Estonia, 13419
Finland
Investigational Site Number 246001
Helsinki, Finland, 00290
Investigational Site Number 246002
Hyvinkää, Finland, 05800
Investigational Site Number 246003
Pori, Finland, 28100
Investigational Site Number 246010
Riihimäki, Finland, 11120
Germany
Investigational Site Number 276011
Bad Nauheim, Germany, 61231
Investigational Site Number 276010
Berlin, Germany, 10117
Investigational Site Number 276007
Berlin, Germany, 12161
Investigational Site Number 276008
Berlin, Germany, 12163
Investigational Site Number 276014
Berlin, Germany, 14059
Investigational Site Number 276018
Deggingen, Germany, 73326
Investigational Site Number 276015
Halle/Saale, Germany, 06108
Investigational Site Number 276005
Hamburg, Germany, 22081
Investigational Site Number 276013
Hamburg, Germany, 22147
Investigational Site Number 276001
Herne, Germany, 44649
Investigational Site Number 276016
Leipzig, Germany, 04103
Investigational Site Number 276017
München, Germany, 80336
Investigational Site Number 276021
Osnabrück, Germany, 49074
Investigational Site Number 276020
Tübingen, Germany, 72076
Investigational Site Number 276019
Zerbst, Germany, 39261
Greece
Investigational Site Number 300002
Heraklion, Greece, 71110
Investigational Site Number 300003
Thessaloniki, Greece, 54636
Investigational Site Number 300005
Thessaloniki, Greece, 57010
Guatemala
Investigational Site Number 320002
Guatemala City, Guatemala, 01009
Investigational Site Number 320003
Guatemala City, Guatemala, 01011
Investigational Site Number 320001
Guatemala, Guatemala, 9090
Hungary
Investigational Site Number 348006
Budapest, Hungary, 1023
Investigational Site Number 348014
Budapest, Hungary, 1027
Investigational Site Number 348025
Budapest, Hungary, 1027
Investigational Site Number 348022
Budapest, Hungary, 1036
Investigational Site Number 348010
Debrecen, Hungary, 4031
Investigational Site Number 348003
Debrecen, Hungary, 4032
Investigational Site Number 348021
Esztergom, Hungary, 2500
Investigational Site Number 348013
Györ, Hungary, 9025
Investigational Site Number 348009
Szolnok, Hungary, 5000
Investigational Site Number 348015
Szombathely, Hungary, 9700
Investigational Site Number 348004
Székesfehérvár, Hungary, 8000
Investigational Site Number 348005
Sátoraljaújhely, Hungary, 3980
Israel
Investigational Site Number 376001
Haifa, Israel, 31048
Investigational Site Number 376010
Haifa, Israel, 31096
Investigational Site Number 376011
Tel Aviv, Israel, 64239
Investigational Site Number 376002
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 380005
Genova, Italy, 16132
Korea, Republic of
Investigational Site Number 410014
Anyang-Si, Korea, Republic of, 431-070
Investigational Site Number 410006
Busan, Korea, Republic of, 602-739
Investigational Site Number 410004
Daegu, Korea, Republic of, 700-721
Investigational Site Number 410017
Daejeon, Korea, Republic of, 301-721
Investigational Site Number 410005
Daejeon, Korea, Republic of, 302-799
Investigational Site Number 410010
Gwangju, Korea, Republic of, 61469
Investigational Site Number 410001
Incheon, Korea, Republic of, 21565
Investigational Site Number 410009
Incheon, Korea, Republic of, 400-711
Investigational Site Number 410011
Jeonju, Korea, Republic of, 561-712
Investigational Site Number 410007
Seoul, Korea, Republic of, 03080
Investigational Site Number 410012
Seoul, Korea, Republic of, 04763
Investigational Site Number 410016
Seoul, Korea, Republic of, 120-752
Investigational Site Number 410003
Seoul, Korea, Republic of, 150-713
Investigational Site Number 410008
Suwon, Korea, Republic of, 443-721
Lithuania
Investigational Site Number 440001
Kaunas, Lithuania, 50009
Investigational Site Number 440006
Klaipeda, Lithuania, LT-92288
Investigational Site Number 440002
Vilnius, Lithuania, LT-08661
Investigational Site Number 440007
Vilnius, Lithuania, LT-08661
Malaysia
Investigational Site Number 458001
Ipoh, Malaysia, 30990
Investigational Site Number 458002
Kuching, Malaysia, 94300
Mexico
Investigational Site Number 484023
Chihuahua, Mexico, 31000
Investigational Site Number 484008
Durango, Mexico, 34080
Investigational Site Number 484018
Guadalajara, Mexico, 44620
Investigational Site Number 484002
Guadalajara, Mexico, 44690
Investigational Site Number 484035
Leon, Mexico, 37000
Investigational Site Number 484009
Merida, Mexico, 97000
Investigational Site Number 484007
Metepec, Mexico, 52140
Investigational Site Number 484010
Mexicali, Mexico, 21200
Investigational Site Number 484003
Mexico City, Mexico, 6726
Investigational Site Number 484019
Monterrey, Mexico, 64000
Investigational Site Number 484020
Monterrey, Mexico, 64000
Investigational Site Number 484005
Monterrey, Mexico, 64460
Investigational Site Number 484004
Mérida, Mexico, 97070
Investigational Site Number 484001
México, D.F., Mexico, 11850
Investigational Site Number 484017
México, Mexico, 06700
Investigational Site Number 484021
Queretaro, Mexico, 76000
Netherlands
Investigational Site Number 528010
Amsterdam, Netherlands, 1056 AB
New Zealand
Investigational Site Number 554004
Christchurch, New Zealand, 8002
Investigational Site Number 554011
Nelson, New Zealand, 7010
Investigational Site Number 554007
Otahuhu, New Zealand, 2025
Investigational Site Number 554002
Rotorua, New Zealand, 3010
Investigational Site Number 554001
Timaru, New Zealand, 7910
Peru
Investigational Site Number 604001
Lima, Peru, 021
Investigational Site Number 604010
Lima, Peru, 14
Investigational Site Number 604008
Lima, Peru, 34
Investigational Site Number 604009
Lima, Peru, LIMA 01
Investigational Site Number 604006
Lima, Peru, LIMA 11
Investigational Site Number 604012
Lima, Peru, LIMA 11
Investigational Site Number 604013
Lima, Peru, LIMA 13
Investigational Site Number 604007
Lima, Peru, LIMA 33
Investigational Site Number 604005
Lima, Peru, LIMA 41
Philippines
Investigational Site Number 608003
Cebu City, Philippines, 6000
Investigational Site Number 608001
Manila, Philippines, 1008
Poland
Investigational Site Number 616014
Bialystok, Poland, 15-099
Investigational Site Number 616002
Bialystok, Poland, 15-351
Investigational Site Number 616003
Bialystok, Poland, 15-879
Investigational Site Number 616019
Bydgoszcz, Poland, 85-168
Investigational Site Number 616054
Bytom, Poland, 41-902
Investigational Site Number 616015
Elblag, Poland, 82-300
Investigational Site Number 616001
Krakow, Poland, 30-510
Investigational Site Number 616005
Lublin, Poland, 20-582
Investigational Site Number 616030
Lublin, Poland, 20-954
Investigational Site Number 616018
Poznan, Poland, 61-397
Investigational Site Number 616016
Szczecin, Poland, 71-252
Investigational Site Number 616006
Torun, Poland, 87-100
Investigational Site Number 616031
Warszawa, Poland, 01-518
Investigational Site Number 616004
Warszawa, Poland, 02-118
Investigational Site Number 616017
Warszawa, Poland, 02-653
Investigational Site Number 616020
Wroclaw, Poland, 50-556
Investigational Site Number 616012
Wroclaw, Poland, 52-416
Portugal
Investigational Site Number 620002
Lisboa, Portugal, 1050-034
Romania
Investigational Site Number 642006
Braila, Romania, 810019
Investigational Site Number 642010
Bucharest, Romania, 011171
Investigational Site Number 642021
Bucuresti, Romania, 010584
Investigational Site Number 642001
Bucuresti, Romania, 010976
Investigational Site Number 642020
Bucuresti, Romania, 020125
Investigational Site Number 642002
Bucuresti, Romania, 020983
Investigational Site Number 642005
Galati, Romania, 800578
Russian Federation
Investigational Site Number 643006
Kemerovo, Russian Federation, 650000
Investigational Site Number 643017
Kemerovo, Russian Federation, 650066
Investigational Site Number 643020
Moscow, Russian Federation, 115404
Investigational Site Number 643001
Moscow, Russian Federation, 115522
Investigational Site Number 643002
Moscow, Russian Federation, 117997
Investigational Site Number 643021
Moscow, Russian Federation, 119049
Investigational Site Number 643004
Moscow, Russian Federation, 119333
Investigational Site Number 643012
Moscow, Russian Federation, 121359
Investigational Site Number 643031
Moscow, Russian Federation, 121374
Investigational Site Number 643030
Moscow, Russian Federation, 125284
Investigational Site Number 643009
Novosibirsk, Russian Federation, 630099
Investigational Site Number 643016
Ryazan, Russian Federation, 390026
Investigational Site Number 643008
Saint-Petersburg, Russian Federation, 192242
Investigational Site Number 643010
Samara, Russian Federation, 443095
Investigational Site Number 643011
Saratov, Russian Federation, 410053
Investigational Site Number 643007
St-Petersburg, Russian Federation, 190068
Investigational Site Number 643032
St-Petersburg, Russian Federation, 191186
Investigational Site Number 643014
St-Petersburg, Russian Federation, 196247
Investigational Site Number 643013
Ufa, Russian Federation, 450005
South Africa
Investigational Site Number 710011
Cape Town, South Africa, 7405
Investigational Site Number 710007
Cape Town, South Africa, 7500
Investigational Site Number 710009
Cape Town, South Africa, 8001
Investigational Site Number 710003
Durban, South Africa, 4001
Investigational Site Number 710002
Durban, South Africa, 4091
Investigational Site Number 710001
Johannesburg, South Africa, 2013
Investigational Site Number 710004
Kempton Park, South Africa, 1619
Investigational Site Number 710005
Pretoria, South Africa, 0002
Investigational Site Number 710006
Pretoria, South Africa, 0084
Investigational Site Number 710010
Stellenbosch, South Africa, 7600
Spain
Investigational Site Number 724016
Barakaldo, Spain, 48903
Investigational Site Number 724015
Barcelona, Spain, 08034
Investigational Site Number 724014
Cádiz, Spain, 11009
Investigational Site Number 724009
La Coruña, Spain, 15006
Investigational Site Number 724001
Málaga, Spain, 29010
Investigational Site Number 724011
Sabadell, Spain, 08208
Investigational Site Number 724012
Santiago De Compostela, Spain, 15705
Investigational Site Number 724013
Santiago De Compostela, Spain, 15706
Investigational Site Number 724022
Sevilla, Spain, 41010
Investigational Site Number 724007
Sevilla, Spain, 41071
Sweden
Investigational Site Number 752002
Uppsala, Sweden, 751 85
Taiwan
Investigational Site Number 158006
Taichung, Taiwan, 40201
Investigational Site Number 158002
Taoyuan County, Taiwan, 33305
Thailand
Investigational Site Number 764001
Bangkok, Thailand, 10400
Investigational Site Number 764003
Bangkok, Thailand, 10700
Turkey
Investigational Site Number 792008
Gaziantep, Turkey, 27310
Ukraine
Investigational Site Number 804003
Dnipro, Ukraine, 49047
Investigational Site Number 804010
Kharkiv, Ukraine, 61058
Investigational Site Number 804013
Kharkiv, Ukraine, 61176
Investigational Site Number 804014
Kyiv, Ukraine, 01103
Investigational Site Number 804004
Kyiv, Ukraine, 03680
Investigational Site Number 804027
Kyiv, Ukraine, 03680
Investigational Site Number 804005
Lviv, Ukraine, 79010
Investigational Site Number 804006
Simferopol, Ukraine, 95017
Investigational Site Number 804011
Vinnytsya, Ukraine, 21018
Investigational Site Number 804009
Zaporizhzhya, Ukraine, 69600
United Kingdom
Investigational Site Number 826004
Doncaster, United Kingdom, DN2 5LT
Investigational Site Number 826006
Edinburgh, United Kingdom, EH4 2XU
Investigational Site Number 826002
Leytonstone, United Kingdom, E11 1NR
Investigational Site Number 826005
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences and Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01146652     History of Changes
Other Study ID Numbers: LTS11210
2010-019262-86 ( EudraCT Number )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases