A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Etanercept; Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Actual): 3080
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1431FWO
    • CEMIC
  • Buenos Aires, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
  • Buenos Aires, Argentina, C1194AAO
    • APRILLUS
  • Buenos Aires, Argentina, C1204AAD
    • Instituto Centenario
  • Buenos Aires, Argentina, C1117ABK
    • CEIM Consultorios Especializados en Investigaciones Médicas
  • Buenos Aires, Argentina, C1425DTG
    • Fundacion Cidea
  • Buenos Aires, Argentina, C1426AAL
    • Atencion Integral En Reumatologia Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
    • Hospital Britanico de Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
    • Hospital General de Agudos Dr. J. M. Ramos Mejia
  • Ciudad Autonoma de Buenos Aires, Argentina, 1111
    • Centro de Investigaciones Reumatologicas y Osteologicas
  • Cordoba, Argentina, 5000
    • Instituto Reumatológico Strusberg
  • Cordoba, Argentina, X5004BAL
    • Hospital Italiano de Cordoba
  • Cordoba Pcia, Argentina, 5016
    • Hospital Privado Cordoba
  • Florencio Varela, Argentina, 1888
    • Centro de Investigaciones Médicas - CIM
  • Lujan, Argentina, 6700
    • Hospital Municipal Nuestra Sra. de Lujan
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino SA
  • Rosario, Argentina, S2000DSV
    • Sanatorio Parque de Rosario
  • Rosario, Santa Fe, Argentina, S2000PBJ
    • Instituto Centralizado de Asistencia e Investigaci
  • San Juan, Argentina, 5400
    • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
  • San Miguel de Tucuman, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
  • Tucuman, Argentina, 4000
    • Centro de Investigaciones Reumatologicas Tucuman
• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz
  • Stockerau, Austria, 2000
    • Landesklinikum Weinviertel Stockerau; Rheumatologie
  • Wien, Austria, 1090
    • Medizinische Universitat Wien
  • Wien, Austria, 1100
    • Rheuma-Zentrum Favoriten Wien
  • Wien, Austria, 1130
    • Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A
• Belgium
  • Brussels, Belgium, 1000
    • CHU St Pierre (St Pierre)
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Kortrijk, Belgium, 8500
    • AZ Groeninge (Vercruysselaan)
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Center of the Republic of Srpska
  • Sarajevo, Bosnia and Herzegovina, 71 000
    • University Clinic Ctr Sarajevo
  • Sarajevo, Bosnia and Herzegovina, 71000
    • General Hospital Prim.dr.Abdulah Nakas
  • Tuzla, Bosnia and Herzegovina, 75000
    • Uni Hospital Center Tuzla
• Canada
  • Quebec, Canada, G1W 4R4
    • Centre Re Recherche Saint-Louis
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • British Columbia
    • Powell River, British Columbia, Canada, V8A 3B6
      • The Medical Arts Health Research Group
    • Victoria, British Columbia, Canada, V8P 5P6
      • Baker, Milton F.
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1C 5B8
      • St. Clare's Mercy Hospital
    • St John's, Newfoundland and Labrador, Canada, A1A 5E8
      • Nexus Clinical Research Centre
  • Ontario
    • Etobicoke, Ontario, Canada, M9C 5N2
      • Arthur Karasik, MD
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Charlton Medical Center
    • Kitchener, Ontario, Canada, N2M 5N6
      • K-W Musculoskeletal Research
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley, Rheumatology
    • St. Catharines, Ontario, Canada, L2N 7E4
      • Niagara Peninsula Arthritis Centre
    • Toronto, Ontario, Canada, M5G 1Z5
      • Mount Sinai Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Institut de Rhumatologie de Montreal
    • Quebec City, Quebec, Canada, G1V 3M7
      • Groupe de Recherche en Rhumatologie et Maladies Osseuses
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS Hopital Fleurimont
    • Trois-rivieres, Quebec, Canada, G8Z 1Y2
      • Centre de Recherche Musculo-Squelettique
• Chile
  • La Serena, Chile, 1700000
    • Hospital San Juan de Dios La Serena
  • Santiago, Chile, 7501126
    • Centro de Estudios Reumatologicos
  • Santiago, Chile, 7500000
    • Centro Medico Prosalud
  • Santiago, Chile, 7500035
    • Interin
  • Santiago, Chile, 8320112
    • Hospital Clínico Pontificia Universidad Católica de Chile
  • Temuco, Chile, 4780000
    • Centro de Investigacion Clinica del Sur
  • Temuco, Chile, 4780000
    • Clinica Alemana de Temuco
  • Viña del Mar, Chile, 2520612
    • Hospital Clinico Viña del Mar- Oncovida
  • Viña del Mar, Chile
    • Centro de Estudios Clinicos V Region Limitada
• Croatia
  • Karlovac, Croatia, 47000
    • General Hospital Karlovac
  • Krapinske Toplice, Croatia, 49217
    • Special Hospital for medical rehabilitation
  • Rijeka, Croatia, 51000
    • Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Universtiy Hospital Dubrava
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Bruntal, Czechia, 792 01
    • Revmatologicka ambulance
  • Hlucin, Czechia, 748 01
    • Revmatologicka ambulance
  • Hostivice, Czechia, 253 01
    • Interni a revmatologicka ordinace
  • Kladno, Czechia, 272 01
    • Revmatologicka a-interni ambulance
  • Ostrava - Moravska Ostrava, Czechia, 702 00
    • Revmatologie MUDr. Klara Sirova s.r.o.
  • Praha, Czechia, 128 50
    • Revmatologicky ustav
  • Praha, Czechia, 140 59
    • Fakultni Thomayerova nemocnice s poliklinikou
  • Praha 4, Czechia, 140 00
    • Revmatologicka ambulance
  • Sokolov, Czechia, 356 01
    • Artroscan s.r.o.
  • Terezin, Czechia, 411 55
    • Revmatologicka Ambulance-Terezin
  • Zlin, Czechia, 748 01
    • PV - MEDICAL, s.r.o.
• Ecuador
  • Cuenca, Ecuador, 101168
    • Hospital Clínica Santa Inés
  • Guayaquil, Ecuador, 593
    • Centro de Reumatología y Rehabilitación
  • Guayaquil, Ecuador, 593
    • OMNI Hospital
  • Guayaquil, Ecuador, EC090114
    • Centro Medico Alcivar 4
  • Quito, Ecuador, 005932
    • Centro Medico Picasso
  • Quito, Ecuador, EC170517
    • Novaclinica Santa Cecilia; Reumatology
• France
  • Amiens, France, 80054
    • CHU d'Amiens Hôpital Nord; Pharmacie Clinique
  • Bordeaux, France, 33000
    • Groupe Hospitalier Pellegrin
  • Clermont Ferrand, France, 63003
    • CHU Hôpital Gabriel Montpied
  • Corbeil Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien
  • Echirolles, France, 38434
    • CHU Grenoble Sud
  • Lyon, France, 69003
    • Hôpital Edouard Herriot; Service de Rhumatologie
  • Orléans, France, 45067
    • CHR Orleans, Hopital Madeleine
  • Paris, France, 75571
    • Hôpital Saint-Antoine; Service de Psychiatrie
  • Paris, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris, France, 75679
    • Hopital Cochin; Gastro Enterologie
  • Rennes, France, 35033
    • Hôpital Sud - CHU de Rennes
  • Roubaix, France, 59056
    • Hopital Victor Provo
  • Rouen, France, 76031
    • CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne, Hopital Bellevue
  • Strasbourg, France, 67098
    • Hôpital General - CHRU de Dijon
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
• Germany
  • Berlin, Germany, 14059
    • Schlosspark-Klinik
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin, Campus Charité Mitte
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Augenklinik
  • Erlangen, Germany, 91056
    • Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN
  • Frankfurt, Germany, 60528
    • Universitaetsklinikum Frankfurt
  • Hamburg, Germany, 20251
    • Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie
  • Hamburg, Germany, 22081
    • Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
  • Herne, Germany, 44649
    • Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus
  • Hildesheim, Germany, 31134
    • Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie
  • Koeln, Germany, 50937
    • Universitatsklinikum Koln, Klinik I fur Innere Medizin
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Muenchen, Germany, 81541
    • Praxiszentrum St. Bonifatius
  • München, Germany, 80337
    • Ludwig Maximilians; Universitaet
  • Osnabrueck, Germany, 49074
    • Rheumatologische Gemeinschaftspraxis
  • Ratingen, Germany, 40882
    • Evangelisches Fachkrankenhaus
• Greece
  • Athens, Greece, 115 27
    • Laiko General Hospital Athen
  • Athens, Greece, 15121
    • Euroclinic of Athens; Internal Medicine & Immunology Dept.
  • Crete, Greece, 71110
    • University General Hospital of Heraklion
  • Larissa, Greece, 411 10
    • University General Hospital of Larissa; Rheumatology Unit
  • Thessaloniki, Greece, 54 642
    • General Hospital of Thessaloniki Hippokration
  • Thessaloniki, Greece, 546 36
    • Euromedica Kyanous Stavros General Hospital
  • Thessaloniki, Greece
    • 424 Military Training Hospital-Egnatia
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft
  • Budapest, Hungary, 1027
    • Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály
  • Budapest, Hungary, 1033
    • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
  • Eger, Hungary, 3300
    • Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.
  • Gyula, Hungary, 5700
    • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
  • Mor, Hungary, 8060
    • Varosi Korhaz-Rendelointezet
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Korhaz
  • Szekszard, Hungary, 7100
    • Clinfan Szolgaltato Kft.
  • Zalaegerszeg, Hungary, 8901
    • Zala Megyei Korhaz; Reumatologia
• India
  • Ahmedabad, India, 380009
    • Vedanta Institute; Medical Sciences
  • Bangalore, India, 560017
    • Manipal Hospital
  • Banglore, India, 560034
    • St.John's Medical College Hospital
  • Hubli, India, 580020
    • Arthritis Super Speciality Centre
  • Hyderabad, India, 500034
    • Care Institute of Medical Sciences
  • Nagpur, India, 440010
    • Jasleen Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Shalby Hospital Limited
• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center
  • Beer Yaacov, Israel, 6093000
    • Assaf Harofeh Medical Center
  • Haifa, Israel, 34362
    • The Lady Davis Carmel Medical Center
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center; Rheumatology
  • Tel Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera A. Cardarelli
    • Napoli, Campania, Italy, 80144
      • Ospedale San Giovanni Bosco; Divisione di Reumatologia
    • Telese Terme, Campania, Italy, 82037
      • Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese
  • Liguria
    • Arenzano, Liguria, Italy, 16011
      • Ospedale La Colletta
    • Genova, Liguria, Italy, 16132
      • Azienda Ospedaliero Universitaria San Martino
  • Lombardia
    • Bergamo, Lombardia, Italy, 24128
      • Ospedali Riuniti di Bergamo
    • Milano, Lombardia, Italy, 20162
      • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
    • Varese, Lombardia, Italy, 21100
      • Ospedale di Circolo e Fondazione Macchi
  • Sicilia
    • Catania, Sicilia, Italy, 95124
      • Presidio Ospedaliero Vittorio Emanuele
  • Toscana
    • Firenze, Toscana, Italy, 50141
      • Azienda Ospedaliera Universitaria Careggi
    • Prato, Toscana, Italy, 59100
      • Ospedale Misericordia e Dolce
• Latvia
  • Bauska, Latvia, 3901
    • L.Krumina GP practice
  • Daugavpils, Latvia, 5417
    • Daugavpils Regional Hospital
  • Liepaja, Latvia, 3400
    • D.Saulite-Kandevica Private Practice
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University Hospital
  • Riga, Latvia, LV 1002
    • Riga East Clinical University Hospital; Clinic Gailezers
  • Riga, Latvia, 1005
    • Clinic ORTO
  • Riga, Latvia, 1021
    • Private Practice EHOKG
• Lithuania
  • Alytus, Lithuania, 62114
    • Alytus Regional S. Kudirkos Hospital, Public Institution
  • Klaipeda, Lithuania, 92288
    • Klaipeda Seamen's Hospital, Public Institution
  • Klaipeda, Lithuania, 92288
    • Klaipeda University Hospital; Public Institution
  • Siauliai, Lithuania, 76231
    • Siauliai Republican Hospital Public Institution
  • Vilnius, Lithuania, 06122
    • Vilnius District Central Outpatient Clinic, Public Institution
• Malaysia
  • Kuala Lumpur, Malaysia, 68100
    • Hospital Selayang
  • Kuching, Malaysia, 93586
    • Hospital Umum Sarawak
  • Penang, Malaysia, 10990
    • Hospital Pulau Pinang
  • Selangor, Malaysia, 46150
    • Sunway Medical Centre
  • Selangor, Malaysia, 47500
    • Sime Darby Medical Centre
  • Perak
    • Ipoh, Perak, Malaysia, 30990
      • Hospital Raja Permaisuri Bainun
• Mexico
  • Chihuahua, Mexico, 31000
    • Hospital Christus Muguerza del Parque; Reumatologia
  • Chihuahua, Mexico, 31238
    • Hospital CIMA Chihuahua; Reumatologia
  • Ciudad Obregon, Mexico, 85000
    • Hospital Privado San Jose de Ciudad Obregon SA de CV
  • Cuernavaca, Mexico, 62270
    • Private Practice Dr. Cortes
  • Delegacion Benito Juarez, Mexico, 03100
    • RM pharma specialist SA de CV
  • Distrito Federal, Mexico, 06600
    • Mentrials S.A. de C.V
  • Durango, Mexico, 34080
    • Centro de Investigacion y Atencion Integral Durango CIAID
  • Guadalajara, Mexico, 44500
    • Mundo Fisico
  • Guadalajara, Mexico, 45040
    • Clinica Hospital Angeles Chapalita
  • Mexicali, Mexico, 21100
    • Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
  • Mexico, Mexico, 03100
    • Mexico Centre for Clinical Research
  • Mexico, Mexico, 06100
    • Comite Mexicano Para la Prevencion de Osteoporosis AC
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Cardiologia Ignacio Chavez
  • Mexico City, Mexico, 06700
    • Inst. Mexicano de Investigacion Clinica
  • Mexico Df, Mexico, 11850
    • Hospital Mocel
  • Miexico City, Mexico, 06700
    • Cliditer SA de CV
  • Saltillo, Mexico, 25000
    • Hospital Universitario de Saltillo
  • San Luis Potosi S.L.P., Mexico, 78240
    • Hospital Central Dr. Ignacio Morones Prieto
  • San Luis Potosí, Mexico, 78200
    • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
  • Torreon, Mexico, 27000
    • Unidad de Enfermedades Reumaticas y Cronicodegenerativas
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Centro de Investigacion del Noroeste SC
  • Sinaloa
    • Culiacán Rosales, Sinaloa, Mexico, 80000
      • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
  • Yucatan
    • Mérida, Yucatan, Mexico, 97000
      • Unidad de Atencion Medica e Investigacion en Salud S.C.
• Netherlands
  • Amsterdam, Netherlands, 1056 AB
    • Jan Van Breemen Instituut
  • Dordrecht, Netherlands, 3318AT
    • Albert Schweitzer Ziekenhuis ; Dordwijk
  • Roosendaal, Netherlands, 4708 AE
    • Franciscus Ziekenhuis
  • Schiedam, Netherlands, 3118 JH
    • Vlietland Hospital
• Philippines
  • Cebu City, Philippines, 6000
    • Cebu Doctors' University Hospital- North General Hospital
  • Cebu City, Philippines, 6000
    • Chong Hua Hospital, Cebu City
  • Iloilo City, Philippines, 5000
    • St. Paul Hospital; Arthritis Center
  • Lipa City, Philippines, 4217
    • Mary Mediatrix Medical Center
  • Makati City, Philippines, 1229
    • Makati Medical Center
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
  • Elblag, Poland, 82-300
    • Wojewodzki Szpital Zespolony w Elblagu
  • Krakow, Poland, 31-121
    • Szpital Specjalistyczny im. J. Dietla
  • Krakow, Poland, 30-119
    • Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii
  • Lublin, Poland, 20-607
    • NZOZ REUMED Sp. z o.o.
  • Nadarzyn, Poland, 05-830
    • Lecznica MAK-MED NZOZ
  • Szczecin, Poland, 71-252
    • SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego
  • Ustron, Poland, 43-450
    • Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny
  • Warszawa, Poland, 02-118
    • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Warszawa, Poland, 02-653
    • ARS Rheumatica Sp.z o. o
  • Wroclaw, Poland, 50-556
    • Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego
• Romania
  • Brasov, Romania, 500365
    • Spitalul Clinic Judetean de Urgenta Brasov
  • Bucharest, Romania, 020475
    • Spitalul Clinic Dr. I Cantacuzino
  • Bucuresti, Romania, 011172
    • Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie
  • Bucuresti, Romania, 020983
    • Centrul de Boli Reumatismale Dr. Ioan Stoia
  • Cluj-Napoca, Romania, 400130
    • Medex SRL
  • Cluj-Napoca, Romania, 400349
    • Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii
  • Iasi, Romania, 700656
    • Spitalul Clinic de Recuperare Iasi
  • Iasi, Romania, 700127
    • CMI Dr.Ciornohuz Adriana
  • Ploiesti, Romania, 100337
    • Spitalul Municipal Ploiesti
  • Sector 2, Romania, 020125
    • Spitalul Clinic Colentina
  • Targoviste, Romania, 130083
    • Spitalul Judetean de Urgenta Targoviste
  • Targu Mures, Romania, 540142
    • Mediab SRL
  • Timisoara, Romania, 300194
    • Spitalul Clinic Municipal de Urgenta Timisoara
• Russian Federation
  • Barnaul, Russian Federation, 656024
    • State institution of health care - Territorial Clinical Hospital
  • Barnaul, Russian Federation, 656038
    • SEI of HPE "Altay State Medical University of Roszdrav"
  • Kazan, Russian Federation, 420097
    • Scientific and research medical complex Your Health
  • Kemerovo, Russian Federation, 650002
    • SIH Kemerovo Regional Clinical Hospital
  • Moscow, Russian Federation, 115093
    • City Hospital No.4
  • Moscow, Russian Federation, 115522
    • Scient Res Inst Rheumat RAMS
  • Moscow, Russian Federation, 121374
    • Moscow State Medical Stomatological University
  • Moscow, Russian Federation, 123060
    • Head Clinical Hospital of Internal Affair Ministry of Russia
  • Novosibirsk, Russian Federation, 630068
    • MHI City Clinical Hospital#19
  • Novosibirsk, Russian Federation, 630099
    • FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS
  • Ryazan, Russian Federation, 390026
    • Ryazan Regional Clinincal Cardiology Dispensary
  • Saratov, Russian Federation, 410002
    • State institution of healthcare "Regional hospital for war veterans"
  • St Petersburg, Russian Federation, 194291
    • Leningradskaya Regional Clinical Hospital; Rheumatology Dept
  • Stavropol, Russian Federation, 355017
    • Stavropol State Medical Academy
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital
  • Voronezh, Russian Federation, 394066
    • Voronezh Regional Clinical Hospital #1
  • Yaroslavl, Russian Federation, 150007
    • MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Belgrade, Serbia, 11040
    • Military Medical Academy
  • Belgrade, Serbia, 11070
    • Clinical Center Bezanijska kosa
  • Niska Banja, Serbia, 18205
    • Institute of Rheumatology and Cardiovascular Diseases; Rheumatology
• South Africa
  • Cape Town, South Africa, 7925
    • Groote Schuur Hospital; Rheumatology Unit
  • Diepkloof, South Africa, 1862
    • Chris Hani Baragwanath Hospital; Rheumatology Department
  • Johannesburg, South Africa, 2193
    • Charlotte Maxeke Academic Hospital
  • Pretoria, South Africa, 0002
    • University of Pretoria; Clinical Trial Unit
• Spain
  • Castellon, Spain, 12004
    • Hospital General de Castellon; Servicio de Reumatologia
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón
  • Badajoz
    • Merida, Badajoz, Spain, 06800
      • Hospital de Merida ;Servicio de Reumatologia
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Cantabria
    • Torrelavega, Cantabria, Spain, 39300
      • Hospital Sierrallana
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
      • Hospital Clínico Universitario de Santiago
  • Madrid
    • San Sebastian de los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofia; Servicio de Reumatologia
  • Malaga
    • Málaga, Malaga, Spain, 29009
      • Hospital Regional Universitario Carlos Haya
  • Sevilla
    • Seville, Sevilla, Spain, 41071
      • Hospital Universitario Virgen Macarena
  • Tenerife
    • S. Cristobal de la Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Reumatologia
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto
• Turkey
  • Antalya, Turkey, 07058
    • Akdeniz Univesity Medical Faculty
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Erzurum, Turkey, 25050
    • Ataturk University Med Faculty
  • Trabzon, Turkey, 61100
    • Karadeniz Tecnical Uni. Med. Fac.
• United Kingdom
  • Birmingham, United Kingdom, B29 6JD
    • Selly Oak Hospital; Rheumatology Dept
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's NHS Trust
  • Cannock, United Kingdom, WS11 5XY
    • Cannock Chase Hospital; Rheumatology
  • Dudley, United Kingdom, DY1 2HQ
    • Russells Hall Hospital; Rheumatology Department
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary NHS Trust
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, E1 1BB
    • Royal London Hospital Outpatients Department
  • London, United Kingdom, E11 1NR
    • Whipps Cross Hospital; Rheumatology Dept
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Salford, United Kingdom, M6 8HD
    • Salford Royal NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital; Rheumatology
  • Westcliffe-on-sea, United Kingdom, SS0 0RY
    • Southend Hospital; Rheumatology Department
  • Wrightington, United Kingdom, WN6 9EP
    • Wrightington Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Uni Of Alabama,Birmingham; Medicine - Rheumatology
    • Huntsville, Alabama, United States, 35801
      • Rheumatology Associates of North Alabama
    • Tuscaloosa, Alabama, United States, 35406
      • Clinical and Translational Research Center of Alabama, PC
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Associates, P.C.
    • Paradise Valley, Arizona, United States, 85253
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Peoria, Arizona, United States, 85381
      • Sun Valley Arthritis Center
    • Phoenix, Arizona, United States, 85027
      • Valley Arthritis Care
    • Scottsdale, Arizona, United States, 85258
      • Advanced Arthritis Care & Research
    • Tucson, Arizona, United States, 85715
      • Camp Lowell Medical Specialists
    • Tucson, Arizona, United States, 85724
      • The University of Arizona
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Little Rock, Arkansas, United States, 72205
      • OrthoArkansas; Orthopedics & Sports Medicine
  • California
    • Covina, California, United States, 91723
      • Samy Metyas, MD, Inc
    • Huntington Beach, California, United States, 92646
      • Talbert Medical Group
    • La Jolla, California, United States, 92037
      • Allergy & Rheumatology Medical Clinic, Inc
    • Los Alamitos, California, United States, 90720
      • Valerius Medical Group
    • Mission Viejo, California, United States, 92692
      • Clinical Interventions Research Institute
    • Murrieta, California, United States, 92563
      • Dr. Brigid Freyne, MD
    • Poway, California, United States, 92064
      • Sharp Rees-Stealy Medical Group
    • San Diego, California, United States, 92108
      • San Diego Arthritis Med Clnc
    • San Diego, California, United States, 92120
      • Purushotham & Akther Kotha Inc
    • San Leandro, California, United States, 94578
      • C Michael Neuwelt MD Inc
    • Santa Maria, California, United States, 93454
      • Pacific Arthritis Ctr Med Grp
    • Santa Monica, California, United States, 90404
      • Orrin M. Troum, Md
    • Torrance, California, United States, 90509
      • Harbor Ucla Medical Center
    • Upland, California, United States, 91786
      • Inland Rheumatology; Clinical Trials, Inc.
    • Whittier, California, United States, 90606
      • Medvin Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Joao Nascimento
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
    • Hamden, Connecticut, United States, 06518
      • Arthritis & Osteoporosis Center Pc
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Zasa Clinical Research
    • Coral Gables, Florida, United States, 33134
      • DC Health Clinic
    • Daytona Beach, Florida, United States, 32117
      • Tsai, Yong
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic Inc.
    • Orange Park, Florida, United States, 32073
      • Arthritis/Osteoporosis Treatment Center
    • Palm Harbor, Florida, United States, 34684
      • Arthritis Rsrch of Florida, Inc.
    • Pensacola, Florida, United States, 32501
      • Baptist Hospital Clinical Research
    • Saint Petersburg, Florida, United States, 33708
      • Pinellas Medical Research, LLC
    • Sarasota, Florida, United States, 34292
      • Lovelace Scientific Resources
    • South Miami, Florida, United States, 33143
      • Centre for Arthritis and Rheumatic Diseases
    • Tampa, Florida, United States, 33609
      • SW Florida Clinical Research
    • Tampa, Florida, United States, 33614
      • Healthpoint Medical Group, Inc
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory Uni ; Division of Rheumatology
    • Atlanta, Georgia, United States, 30342
      • Arthritis & Rheumatology of Georgia
    • Duluth, Georgia, United States, 30096
      • North Georgia Rheumatology
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
    • Savannah, Georgia, United States, 31405
      • St. Joseph'S/Candler Health System, Inc.; Office of Research
  • Idaho
    • Boise, Idaho, United States, 83702
      • Sonora Clinical Research
    • Boise, Idaho, United States, 83702
      • St. Luke's Intermountain Research Center
    • Boise, Idaho, United States, 83704
      • Selah Medical Ctr
    • Coeur d'Alene, Idaho, United States, 83814
      • Coeur D'Alene Arthritis Clinic
    • Meridian, Idaho, United States, 83642
      • Idaho Arthritis Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60616
      • Apex Medical Research, AMR, Inc.
    • Peoria, Illinois, United States, 61602
      • Methodist Medical Center of Ilinois
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Northern Indiana Research Alliance
    • Indianapolis, Indiana, United States, 46227
      • Diagnostic Rheumatology & Research
    • South Bend, Indiana, United States, 46601
      • Memorial Medical Group Clinical Research
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves Gilbert Clinic
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis & Diabetes Clinic, Inc
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health System
  • Maryland
    • Baltimore, Maryland, United States, 21286
      • Rheumatology Associates of Baltimore
    • Hagerstown, Maryland, United States, 21740
      • Osteoporosis & Clinical Trials Center
    • Wheaton, Maryland, United States, 20902
      • Center For Rheumatology & Bone Research
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Phase III Clinical Research
    • Worcester, Massachusetts, United States, 01610
      • Clinical Pharmacology Study Group
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center
  • Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Research Center
    • Kalamazoo, Michigan, United States, 49009
      • Rheumatology, P.C.; Medical Arts Building
    • Lansing, Michigan, United States, 48910
      • Advanced Rheumatology, PC
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Regional Hospital
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St. Paul Rheumatology
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Jackson Arthritis Clinic
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Med Clinics, Inc.
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Univ of Nebraska Medical CTR
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Advanced Biomedical Research of America
    • Las Vegas, Nevada, United States, 89128
      • Innovative Health Research
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center, Rheumatology 5C
    • Nashua, New Hampshire, United States, 03060
      • Nashua Rheumatology - Foundation Medical Partners
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
    • Teaneck, New Jersey, United States, 07666
      • Rheumatology Associates Of New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Arthritis Rheumatic & Back Disease Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
    • Las Cruces, New Mexico, United States, 88011
      • Arthritis and Osteoporosis Associates of New Mexico
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center.
    • Brooklyn, New York, United States, 11201
      • Arthritis & Osteoporosis Medical Associates, Pllc
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Inst for Med Ed&Res
    • Olean, New York, United States, 14760
      • Southern Tier Arthritis & Rheumatism
    • Syracuse, New York, United States, 13210
      • Arthritis Health Associates; Clinical Research
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Arthritis & Osteoporosis Center, PA
    • Charlotte, North Carolina, United States, 28210
      • Carolina Bone & Joint P.A.
    • Charlotte, North Carolina, United States, 28204
      • Joint & Muscle Research Institute
    • Durham, North Carolina, United States, 27704
      • Durham Rheumatology
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory LLC
    • Raleigh, North Carolina, United States, 27617
      • Shanahan Rheumatology & Immunology, PLLC
    • Sanford, North Carolina, United States, 27330
      • Specialty Medical Clinic and Research Center
    • Wilmington, North Carolina, United States, 28401
      • Carolina Arthritis Associates, PA
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Health Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Cincinnati Rheumatic Disease Study Group
    • Cleveland, Ohio, United States, 44109
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43215
      • Columbus Arthritis Center
    • Columbus, Ohio, United States, 43210
      • Ohio State Univ Med Center
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic
    • Toledo, Ohio, United States, 43606
      • Clinical Research Source, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Indiana, Pennsylvania, United States, 15701
      • Ilumina Clinical Associates
    • Limerick, Pennsylvania, United States, 19468
      • PMA Medical Specialists
    • Perkasie, Pennsylvania, United States, 18944
      • Pivotal Clinical Research, Llc
    • Philadelphia, Pennsylvania, United States, 19152
      • Arthritis Group
    • Pittsburgh, Pennsylvania, United States, 15213-2582
      • University of Pittsburgh Medical Center Health System; Infectious Disease
    • Wexford, Pennsylvania, United States, 15090
      • Allegheny Rheumatology
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading
    • Wyomissing, Pennsylvania, United States, 19610
      • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Columbia Arthritis Center (Partnership Practice)
    • Myrtle Beach, South Carolina, United States, 29572
      • South Carolina Research Center
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Brown Clinic
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Ramesh Gupta - PP
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center for Clinical Research
    • Corpus Christi, Texas, United States, 78404
      • Adriana Pop-Moody MD Clinic PA
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research
    • Fort Worth, Texas, United States, 76109
      • Leading Edge Research, PA; Office of Dr. Burbano
    • Houston, Texas, United States, 77074
      • Houston Inst. For Clinical Research
    • Houston, Texas, United States, 77004
      • Rheumatic Disease Clin Res Ctr
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology
    • Richardson, Texas, United States, 75080
      • Leading Edge Research, PA; Office of Dr. Burbano
    • San Antonio, Texas, United States, 78217
      • Texas Arthritis Research Center
    • Waco, Texas, United States, 76710
      • Arthritis & Osteoporosis Clinic
  • Virginia
    • Burke, Virginia, United States, 22015
      • Arthritis and Rheumatic Disease Associates
    • Norfolk, Virginia, United States, 23510
      • Sentara Medical Group
  • Washington
    • Kennewick, Washington, United States, 99336
      • Apex Clinical Research
    • Seattle, Washington, United States, 98104
      • Seattle Rheumatology Associates
    • Tacoma, Washington, United States, 98405
      • Office of George Krick, Md
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheum & Pulmonary Clinic
    • Clarksburg, West Virginia, United States, 26301
      • Mountain State Clinical Research
  • Wisconsin
    • Racine, Wisconsin, United States, 53406
      • Arthritis Centre; Suite 103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants with moderate to severe RA of greater than or equal to (>=6) months duration
• Inadequate response to at least one non-biologic DMARD
• Positive for Rheumatoid Factor (RF) and/or anti-cyclic citrullinated peptide (CCP) antibodies at screening
• Have C-reactive protein (CRP) greater than (>) 0.3 milligrams per deciliter (mg/dL) at screening or at the baseline visit
• Swollen joint count (SJC) >=8 (66 joint count) and tender joint count (TJC) >= 8 (68 joint count) during screening or at the baseline visit
• History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low High Density Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis
• At the time of randomization, will have discontinued infliximab, adalimumab, golimumab, or certolizumab for >= 4 weeks

Exclusion Criteria:

• Major surgery (including joint surgery or coronary revascularization) within 8 weeks prior to screening or planned major surgery within 1 year of study start
• Rheumatic autoimmune disease other than RA
• History of or current inflammatory joint disease other than RA
• Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (myocardial infarction, revascularization, stroke, transient ischemic attack, or acute coronary syndrome)
• Current or previous (within the past 2 years) evidence of serious uncontrolled concomitant pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disease
• Uncontrolled disease states, such as asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
• Pre-existing central nervous system demyelinating or seizure disorders
• History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations
• Current liver disease as determined by the investigator; a history of asymptomatic elevations in liver function tests (LFTs) is not considered an exclusion
• Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds
• Any major episode of infection requiring hospitalization or treatment with IV antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening visit
• Active tuberculosis (TB) requiring treatment within 3 years prior to baseline
• Latent TB diagnosed during screening that has not been appropriately treated
• Primary or secondary immunodeficiency (history of or currently active)
• Moderate to severe heart failure
• Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
• Breast feeding mothers
• History of alcohol, drug or chemical abuse within the 6 months prior to screening
• Participants with lack of peripheral venous access
• Participants with a history of allergic reactions to latex
• Previous treatment with non-tumor necrosis factor (non-TNF)-inhibitor biologic therapy
• Treatment with any investigational agent within 4 weeks of screening visit
• Treatment with any cell depleting therapies within 1 year of baseline
• Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline visit
• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline visit
• Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab	Drug: Tocilizumab; Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.; Other Names: Actemra
Active Comparator: Etanercept	Drug: Etanercept; Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event	Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.	From baseline up to 4.9 years
Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event	Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke	From baseline up to 4.9 years
Time to First CV-EAC Adjudicated Event - Sensitivity Analysis	Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis	From Baseline up to 4.9 years
Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis	Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis	From Baseline up to 4.9 years
Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis	Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses	From baseline up to 4.9 years
Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis	Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses	From baseline up to 4.9 years
Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date	Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).	From Baseline up to 4.9 years
Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date	Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).	From Baseline up to 4.9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Time to First Occurrence of an Expanded CV Composite Endpoint	Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.	From baseline up to 4.9 years
Percentages of Participants With an Expanded CV Composite Endpoint	Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.	From baseline up to 4.9 years
Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction	Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction	From baseline up to 4.9 years
Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction	Percentage of patients reporting Individual component of primary endpoint: non-fatal Myocardial Infarction	From baseline up to 4.9 years
Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death	Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death	From baseline up to 4.9 years
Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death	Percentage of patients reporting Individual component of primary endpoint: cardiovascular death	From baseline up to 4.9 years
Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke	Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke	From baseline up to 4.9 years
Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke		From baseline up to 4.9 years
Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality	Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality	From baseline up to 4.9 years
Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality	Percentage of patients reporting Individual component of primary endpoint: All-cause mortality	From baseline up to 4.9 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, Warne C, Musselman D, Brockwell L, Shittu E, Klearman M, Fleming TR. Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):31-40. doi: 10.1002/art.41095.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2011
• Primary Completion (Actual): March 25, 2016
• Study Completion (Actual): March 25, 2016

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: WA25204; 2010-020065-24 (EudraCT Number)