546
Participants
Start Date
October 31, 2012
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
Sarilumab
Pharmaceutical form:solution Route of administration: subcutaneous
placebo
Pharmaceutical form:solution Route of administration: subcutaneous
hydroxychloroquine
Dispensed according to the local practice.
methotrexate
Dispensed according to the local practice.
sulfasalazine
Dispensed according to the local practice.
leflunomide
Dispensed according to the local practice.
Investigational Site Number 604010, Lima
Investigational Site Number 158006, Taipei
Investigational Site Number 724014, Cadiz
Investigational Site Number 348022, Budapest
Investigational Site Number 040003, Vienna
Investigational Site Number 032019, Caba
Investigational Site Number 032016, Capital Federal
Investigational Site Number 040004, Stockerau
Investigational Site Number 554007, Otahuhu
Investigational Site Number 554005, Hamilton
Investigational Site Number 348003, Debrecen
Investigational Site Number 554006, Wellington
Investigational Site Number 036014, Victoria Park
Investigational Site Number 554011, Nelson
Investigational Site Number 554001, Timaru
Investigational Site Number 348004, Veszprém
Investigational Site Number 348017, Veszprém
Investigational Site Number 276010, Berlin
Investigational Site Number 840115, Roslyn
Investigational Site Number 840118, Smithtown
Investigational Site Number 276001, Berlin
Investigational Site Number 203007, Prague
Investigational Site Number 840139, Syracuse
Investigational Site Number 276014, Berlin
Investigational Site Number 840106, Orchard Park
Investigational Site Number 840121, Rochester
Investigational Site Number 724009, A Coruña
Investigational Site Number 840117, Pittsburgh
Investigational Site Number 724017, Santiago de Compostela
Investigational Site Number 724013, Santiago de Compostela
Investigational Site Number 380005, Genova
Investigational Site Number 840009, Duncansville
Investigational Site Number 840062, Reading
Investigational Site Number 840130, Lewes
Investigational Site Number 380014, Milan
Investigational Site Number 804011, Vinnytsia
Investigational Site Number 484010, Mexicali
Investigational Site Number 840055, Frederick
Investigational Site Number 792007, Edirne
Investigational Site Number 276013, Hamburg
Investigational Site Number 840124, Clarksburg
Investigational Site Number 792008, Gaziantep
Investigational Site Number 840123, Charlotte
Investigational Site Number 840116, Wilmington
Investigational Site Number 724001, Málaga
Investigational Site Number 840058, Columbia
Investigational Site Number 484023, Chihuahua City
Investigational Site Number 376001, Haifa
Investigational Site Number 032015, Buenos Aires
Investigational Site Number 840128, Ormond Beach
Investigational Site Number 840125, DeBary
Investigational Site Number 840006, Orlando
Investigational Site Number 840126, Vero Beach
Investigational Site Number 380013, Udine
Investigational Site Number 840048, Miami
Investigational Site Number 158002, Taoyuan
Investigational Site Number 840140, Tampa
Investigational Site Number 840024, Naples
Investigational Site Number 840060, Sarasota
Investigational Site Number 840063, Palm Harbor
Investigational Site Number 840138, Birmingham
Investigational Site Number 840070, Anniston
Investigational Site Number 840059, Memphis
Investigational Site Number 840025, Jackson
Investigational Site Number 840037, Tupelo
Investigational Site Number 276019, Zerbst
Investigational Site Number 840015, Lexington
Investigational Site Number 724007, Seville
Investigational Site Number 484018, Guadalajara
Investigational Site Number 484002, Guadalajara
Investigational Site Number 840137, Saint Clair Shores
Investigational Site Number 724016, Barakaldo
Investigational Site Number 840150, Lansing
Investigational Site Number 276021, Osnabrück
Investigational Site Number 376003, Petah Tikva
Investigational Site Number 380002, Florence
Investigational Site Number 376002, Tel Litwinsky
Investigational Site Number 300005, Thessaloniki
Investigational Site Number 804013, Kharkiv
Investigational Site Number 276011, Bad Nauheim
Investigational Site Number 484019, Monterrey
Investigational Site Number 484020, Monterrey
Investigational Site Number 484005, Monterrey
Investigational Site Number 840112, Lincoln
Investigational Site Number 804009, Zaporizhzhya
Investigational Site Number 840109, Lake Charles
Investigational Site Number 840120, Baton Rouge
Investigational Site Number 300002, Heraklion
Investigational Site Number 276020, Tübingen
Investigational Site Number 840127, Oklahoma City
Investigational Site Number 276018, Deggingen
Investigational Site Number 840011, Tulsa
Investigational Site Number 840074, Mesquite
Investigational Site Number 840022, Dallas
Investigational Site Number 203006, Zlín
Investigational Site Number 484021, Querétaro
Investigational Site Number 840133, Houston
Investigational Site Number 840129, Houston
Investigational Site Number 840132, Austin
Investigational Site Number 840114, El Paso
Investigational Site Number 840201, Denver
Investigational Site Number 276017, München
Investigational Site Number 158005, Kaohsiung City
Investigational Site Number 840018, Idaho Falls
Investigational Site Number 840110, Meridian
Investigational Site Number 840142, Phoenix
Investigational Site Number 840141, Glendale
Investigational Site Number 840131, Whittier
Investigational Site Number 276004, Erlangen
Investigational Site Number 840049, Upland
Investigational Site Number 840111, La Jolla
Investigational Site Number 840135, San Diego
Investigational Site Number 840134, Fullerton
Investigational Site Number 840100, Stanford
Investigational Site Number 840021, Santa Maria
Investigational Site Number 380011, Catania
Investigational Site Number 840036, Spokane
Investigational Site Number 643001, Moscow
Investigational Site Number 643021, Moscow
Investigational Site Number 643008, Saint Petersburg
Investigational Site Number 643010, Samara
Investigational Site Number 643022, Novosibirsk
Investigational Site Number 642014, Iași
Investigational Site Number 840052, Kansas City
Investigational Site Number 032008, Buenos Aires
Investigational Site Number 032006, Caba
Investigational Site Number 032020, Córdoba
Investigational Site Number 032017, La Plata
Investigational Site Number 076016, Curitiba
Investigational Site Number 152015, Temuco
Investigational Site Number 170001, Bogotá
Investigational Site Number 170006, Bogotá
Investigational Site Number 170012, Bogotá
Investigational Site Number 170007, Bucaramanga
Investigational Site Number 170009, Bucaramanga
Investigational Site Number 170014, Chía
Investigational Site Number 170019, Medellín
Investigational Site Number 218003, Cuenca
Investigational Site Number 484024, Guadalajara
Investigational Site Number 620007, Ponte de Lima
Investigational Site Number 792009, Samsun
Investigational Site Number 032010, Ramos Mejía
Investigational Site Number 032013, Rosario
Investigational Site Number 032004, San Miguel de Tucumán
Investigational Site Number 032009, Zárate
Investigational Site Number 076001, Curitiba
Investigational Site Number 076006, Goiânia
Investigational Site Number 076010, Juiz de Fora
Investigational Site Number 076005, Rio de Janeiro
Investigational Site Number 076015, Rio de Janeiro
Investigational Site Number 124005, Toronto
Investigational Site Number 124009, Trois-Rivières
Investigational Site Number 124104, Victoria
Investigational Site Number 203008, Hostivice
Investigational Site Number 203004, Ostrava
Investigational Site Number 203002, Uherské Hradiště
Investigational Site Number 218001, Guayaquil
Investigational Site Number 218002, Quito
Investigational Site Number 276015, Halle
Investigational Site Number 276016, Leipzig
Investigational Site Number 320002, Guatemala City
Investigational Site Number 320003, Guatemala City
Investigational Site Number 320001, Guatemala City
Investigational Site Number 440005, Kaunas
Investigational Site Number 440006, Klaipėda
Investigational Site Number 440007, Vilnius
Investigational Site Number 484017, México
Investigational Site Number 604009, Lima
Investigational Site Number 604006, Lima
Investigational Site Number 604012, Lima
Investigational Site Number 604013, Lima
Investigational Site Number 604001, Lima
Investigational Site Number 604008, Lima
Investigational Site Number 604007, Lima
Investigational Site Number 604005, Lima
Investigational Site Number 604014, Lima
Investigational Site Number 616014, Bialystok
Investigational Site Number 616019, Bydgoszcz
Investigational Site Number 616015, Elblag
Investigational Site Number 616018, Poznan
Investigational Site Number 616016, Szczecin
Investigational Site Number 616004, Warsaw
Investigational Site Number 616017, Warsaw
Investigational Site Number 616020, Wroclaw
Investigational Site Number 620002, Lisbon
Investigational Site Number 620004, Lisbon
Investigational Site Number 642001, Bucharest
Investigational Site Number 642012, Bucharest
Investigational Site Number 642002, Bucharest
Investigational Site Number 703001, Košice
Investigational Site Number 410017, Daejeon
Investigational Site Number 410016, Seoul
Investigational Site Number 724015, Barcelona
Investigational Site Number 724011, Sabadell
Investigational Site Number 804014, Kyiv
Investigational Site Number 804027, Kyiv
Lead Sponsor
Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY