Clinical trial NCT01331837: A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 3080
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event
timeFrame: From baseline up to 4.9 years
measure: Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event
timeFrame: From baseline up to 4.9 years
measure: Time to First CV-EAC Adjudicated Event - Sensitivity Analysis
timeFrame: From Baseline up to 4.9 years
measure: Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis
timeFrame: From Baseline up to 4.9 years
measure: Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis
timeFrame: From baseline up to 4.9 years
measure: Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis
timeFrame: From baseline up to 4.9 years
measure: Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date
timeFrame: From Baseline up to 4.9 years
measure: Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date
timeFrame: From Baseline up to 4.9 years
Secondary outcomes:
measure: The Time to First Occurrence of an Expanded CV Composite Endpoint
timeFrame: From baseline up to 4.9 years
measure: Percentages of Participants With an Expanded CV Composite Endpoint
timeFrame: From baseline up to 4.9 years
measure: Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction
timeFrame: From baseline up to 4.9 years
measure: Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction
timeFrame: From baseline up to 4.9 years
measure: Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death
timeFrame: From baseline up to 4.9 years
measure: Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death
timeFrame: From baseline up to 4.9 years
measure: Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke
timeFrame: From baseline up to 4.9 years
measure: Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke
timeFrame: From baseline up to 4.9 years
measure: Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality
timeFrame: From baseline up to 4.9 years
measure: Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality
timeFrame: From baseline up to 4.9 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uni Of Alabama,Birmingham; Medicine - Rheumatology
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinical and Translational Research Center of Alabama, PC
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Research, Pllc
state: Arizona
city: Peoria
country: United States
facility: Sun Valley Arthritis Center
state: Arizona
city: Phoenix
country: United States
facility: Valley Arthritis Care
state: Arizona
city: Scottsdale
country: United States
facility: Advanced Arthritis Care & Research
state: Arizona
city: Tucson
country: United States
facility: Camp Lowell Medical Specialists
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: OrthoArkansas; Orthopedics & Sports Medicine
state: Arkansas
city: Covina
country: United States
facility: Samy Metyas, MD, Inc
state: California
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: La Jolla
country: United States
facility: Allergy & Rheumatology Medical Clinic, Inc
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group
state: California
city: Mission Viejo
country: United States
facility: Clinical Interventions Research Institute
state: California
city: Murrieta
country: United States
facility: Dr. Brigid Freyne, MD
state: California
city: Poway
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Med Clnc
state: California
city: San Diego
country: United States
facility: Purushotham & Akther Kotha Inc
state: California
city: San Leandro
country: United States
facility: C Michael Neuwelt MD Inc
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Ctr Med Grp
state: California
city: Santa Monica
country: United States
facility: Orrin M. Troum, Md
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Upland
country: United States
facility: Inland Rheumatology; Clinical Trials, Inc.
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
state: Colorado
city: Bridgeport
country: United States
facility: Joao Nascimento
state: Connecticut
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Hamden
country: United States
facility: Arthritis & Osteoporosis Center Pc
state: Connecticut
city: Boynton Beach
country: United States
facility: ZASA Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: DC Health Clinic
state: Florida
city: Daytona Beach
country: United States
facility: Tsai, Yong
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc.
state: Florida
city: Orange Park
country: United States
facility: Arthritis/Osteoporosis Treatment Center
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Rsrch of Florida, Inc.
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Medical Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: South Miami
country: United States
facility: Centre for Arthritis and Rheumatic Diseases
state: Florida
city: Tampa
country: United States
facility: SW Florida Clinical Research
state: Florida
city: Tampa
country: United States
facility: Healthpoint Medical group, Inc
state: Florida
city: Atlanta
country: United States
facility: Emory Uni ; Division of Rheumatology
state: Georgia
city: Atlanta
country: United States
facility: Arthritis & Rheumatology of Georgia
state: Georgia
city: Duluth
country: United States
facility: North Georgia Rheumatology
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Savannah
country: United States
facility: St. Joseph'S/Candler Health System, Inc.; Office of Research
state: Georgia
city: Boise
country: United States
facility: Sonora Clinical Research
state: Idaho
city: Boise
country: United States
facility: St. Luke's Intermountain Research Center
state: Idaho
city: Boise
country: United States
facility: Selah Medical Ctr
state: Idaho
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthritis Clinic
state: Idaho
city: Meridian
country: United States
facility: Idaho Arthritis Center
state: Idaho
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Apex Medical Research, AMR, Inc.
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Ilinois
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology & Research
state: Indiana
city: South Bend
country: United States
facility: Memorial Medical Group Clinical Research
state: Indiana
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity
state: Kentucky
city: Monroe
country: United States
facility: Arthritis & Diabetes Clinic, Inc
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Baltimore
country: United States
facility: Rheumatology Associates of Baltimore
state: Maryland
city: Hagerstown
country: United States
facility: Osteoporosis & Clinical Trials Center
state: Maryland
city: Wheaton
country: United States
facility: Center For Rheumatology & Bone Research
state: Maryland
city: Fall River
country: United States
facility: Phase Iii Clinical Research
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Flint
country: United States
facility: Hurley Research Center
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology, P.C.; Medical Arts Building
state: Michigan
city: Lansing
country: United States
facility: Advanced Rheumatology, PC
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Regional Hospital
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology
state: Minnesota
city: Minneapolis
country: United States
facility: Va Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Flowood
country: United States
facility: Jackson Arthritis Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Med Clinics, Inc.
state: Mississippi
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Omaha
country: United States
facility: Univ of Nebraska Medical Ctr
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C
state: New Hampshire
city: Nashua
country: United States
facility: Nashua Rheumatology - Foundation Medical Partners
state: New Hampshire
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Teaneck
country: United States
facility: Rheumatology Associates Of New Jersey
state: New Jersey
city: Voorhees
country: United States
facility: Arthritis Rheumatic & Back Disease Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Las Cruces
country: United States
facility: Arthritis and Osteoporosis Associates of New Mexico
state: New Mexico
city: Brooklyn
country: United States
facility: Arthritis & Osteoporosis Medical Associates, Pllc
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center.
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Inst for Med Ed&Res
state: New York
city: Olean
country: United States
facility: Southern Tier Arthritis & Rheumatism
state: New York
city: Syracuse
country: United States
facility: Arthritis Health Associates; Clinical Research
state: New York
city: Asheville
country: United States
facility: Asheville Arthritis & Osteoporosis Center, PA
state: North Carolina
city: Charlotte
country: United States
facility: Joint & Muscle Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Bone & Joint P.A.
state: North Carolina
city: Durham
country: United States
facility: Durham Rheumatology
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory LLC
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunology, PLLC
state: North Carolina
city: Sanford
country: United States
facility: Specialty Medical Clinic and Research Center
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates, Pa
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Center
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Med Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Arthritis Center
state: Ohio
city: Toledo
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Indiana
country: United States
facility: Ilumina Clinical Associates
state: Pennsylvania
city: Limerick
country: United States
facility: PMA Medical Specialists
state: Pennsylvania
city: Perkasie
country: United States
facility: Pivotal Clinical Research, Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System; Infectious Disease
state: Pennsylvania
city: Wexford
country: United States
facility: Allegheny Rheumatology
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center (Partnership Practice)
state: South Carolina
city: Myrtle Beach
country: United States
facility: South Carolina Research Center
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic
state: South Dakota
city: Memphis
country: United States
facility: Ramesh Gupta - PP
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop-Moody MD Clinic PA
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: Leading Edge Research, PA; Office of Dr. Burbano
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clin Res Ctr
state: Texas
city: Houston
country: United States
facility: Houston Inst. For Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: Richardson
country: United States
facility: Leading Edge Research, PA; Office of Dr. Burbano
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic
state: Texas
city: Burke
country: United States
facility: Arthritis and Rheumatic Disease Associates
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Kennewick
country: United States
facility: Apex Clinical Research
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Tacoma
country: United States
facility: Office of George Krick, Md
state: Washington
city: Beckley
country: United States
facility: Rheum & Pulmonary Clinic
state: West Virginia
city: Clarksburg
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Racine
country: United States
facility: Arthritis Centre; Suite 103
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Buenos Aires
country: Argentina
facility: CEIM Consultorios Especializados en Investigaciones Médicas
city: Buenos Aires
country: Argentina
facility: APRILLUS
city: Buenos Aires
country: Argentina
facility: Instituto centenario
city: Buenos Aires
country: Argentina
facility: Fundación CIDEA
city: Buenos Aires
country: Argentina
facility: Atencion Integral En Reumatologia Buenos Aires
city: Buenos Aires
country: Argentina
facility: CEMIC
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. J. M. Ramos Mejia
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Reumatologicas y Osteologicas
city: Cordoba Pcia
country: Argentina
facility: Hospital Privado Cordoba
city: Cordoba
country: Argentina
facility: Instituto Reumatológico Strusberg
city: Cordoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Florencio Varela
country: Argentina
facility: Centro de Investigaciones Médicas - CIM
city: Lujan
country: Argentina
facility: Hospital Municipal Nuestra Sra. de Lujan
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Rosario, Santa Fe
country: Argentina
facility: Instituto Centralizado de Asistencia e Investigaci
city: Rosario
country: Argentina
facility: Sanatorio Parque de Rosario
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
city: San Miguel de Tucuman
country: Argentina
facility: Centro Médico Privado de Reumatología
city: Tucuman
country: Argentina
facility: Centro de Investigaciones Reumatologicas Tucuman
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Stockerau
country: Austria
facility: Landesklinikum Weinviertel Stockerau; Rheumatologie
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Rheuma-Zentrum Favoriten Wien
city: Wien
country: Austria
facility: Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A
city: Brussels
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Kortrijk
country: Belgium
facility: AZ Groeninge (Vercruysselaan)
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinic Ctr Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: General Hospital Prim.dr.Abdulah Nakas
city: Tuzla
country: Bosnia and Herzegovina
facility: Uni Hospital Center Tuzla
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Powell River
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Victoria
country: Canada
facility: Baker, Milton F.
state: British Columbia
city: St John's
country: Canada
facility: Nexus Clinical Research Centre
state: Newfoundland and Labrador
city: St John's
country: Canada
facility: St. Clare'S Mercy Hospital
state: Newfoundland and Labrador
city: Etobicoke
country: Canada
facility: Arthur Karasik, MD
state: Ontario
city: Hamilton
country: Canada
facility: Charlton Medical Center
state: Ontario
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research
state: Ontario
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley, Rheumatology
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Peninsula Arthritis Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Institut de Rhumatologie de Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses
state: Quebec
city: Sherbrooke
country: Canada
facility: Chus Hopital Fleurimont
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: Centre Re Recherche Saint-Louis
city: La Serena
country: Chile
facility: Hospital San Juan de Dios La Serena
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: Interin
city: Santiago
country: Chile
facility: Centro de Estudios Reumatológicos
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad Catolica de Chile
city: Temuco
country: Chile
facility: Centro de Investigacion Clinica del Sur
city: Temuco
country: Chile
facility: Clinica Alemana de Temuco
city: Viña del Mar
country: Chile
facility: Hospital Clinico Viña del Mar- Oncovida
city: Viña del Mar
country: Chile
facility: Centro de Estudios Clinicos V Region Limitada
city: Karlovac
country: Croatia
facility: General Hospital Karlovac
city: Krapinske Toplice
country: Croatia
facility: Special Hospital for Medical Rehabilitation
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Universtiy Hospital Dubrava
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Bruntal
country: Czechia
facility: Revmatologicka ambulance
city: Hlucin
country: Czechia
facility: Revmatologicka Ambulance
city: Hostivice
country: Czechia
facility: Interni a revmatologicka ordinace
city: Kladno
country: Czechia
facility: Revmatologicka a-interni ambulance
city: Ostrava - Moravska Ostrava
country: Czechia
facility: Revmatologie MUDr. Klara Sirova s.r.o.
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha
country: Czechia
facility: Revmatologicky Ustav
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice s poliklinikou
city: Sokolov
country: Czechia
facility: Artroscan s.r.o.
city: Terezin
country: Czechia
facility: Revmatologicka Ambulance-Terezin
city: Zlin
country: Czechia
facility: PV - Medical, s.r.o.
city: Cuenca
country: Ecuador
facility: Hospital Clínica Santa Inés
city: Guayaquil
country: Ecuador
facility: Centro de Reumatología y Rehabilitación
city: Guayaquil
country: Ecuador
facility: OMNI Hospital
city: Guayaquil
country: Ecuador
facility: Centro Medico Alcivar 4
city: Quito
country: Ecuador
facility: Centro Medico Picasso
city: Quito
country: Ecuador
facility: Novaclinica Santa Cecilia; Reumatology
city: Amiens
country: France
facility: CHU d'Amiens Hôpital Nord; Pharmacie Clinique
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Clermont Ferrand
country: France
facility: CHU Hopital Gabriel Montpied
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Echirolles
country: France
facility: CHU Grenoble Sud
city: Lyon
country: France
facility: Hôpital Edouard Herriot; Service de Rhumatologie
city: Orléans
country: France
facility: CHR Orleans, Hopital Madeleine
city: Paris
country: France
facility: Hôpital Saint-Antoine; Service de Psychiatrie
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Cochin; Gastro Enterologie
city: Rennes
country: France
facility: Hôpital Sud - CHU de Rennes
city: Roubaix
country: France
facility: Hôpital Victor Provo
city: Rouen
country: France
facility: CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne, Hopital Bellevue
city: Strasbourg
country: France
facility: Hôpital General - CHRU de Dijon
city: Toulouse
country: France
facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin, Campus Charité Mitte
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Augenklinik
city: Erlangen
country: Germany
facility: Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie
city: Hamburg
country: Germany
facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie
city: Koeln
country: Germany
facility: Universitätsklinikum Köln, Klinik I für Innere Medizin
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Muenchen
country: Germany
facility: Praxiszentrum St. Bonifatius
city: München
country: Germany
facility: Ludwig Maximilians; Universitaet
city: Osnabrueck
country: Germany
facility: Rheumatologische Gemeinschaftspraxis
city: Ratingen
country: Germany
facility: Evangelisches Fachkrankenhaus
city: Athens
country: Greece
facility: Laiko General Hospital Athen
city: Athens
country: Greece
facility: Euroclinic of Athens; Internal Medicine & Immunology Dept.
city: Crete
country: Greece
facility: University General Hospital of Heraklion
city: Larissa
country: Greece
facility: University General Hospital of Larissa; Rheumatology Unit
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokration
city: Thessaloniki
country: Greece
facility: Euromedica Kyanous Stavros General Hospital
city: Thessaloniki
country: Greece
facility: 424 Military Training Hospital-Egnatia
city: Budapest
country: Hungary
facility: Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
city: Eger
country: Hungary
facility: Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
city: Mor
country: Hungary
facility: Varosi Korhaz-Rendelointezet
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft.
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz; Reumatologia
city: Ahmedabad
country: India
facility: Shalby Hospital Limited
state: Gujarat
city: Ahmedabad
country: India
facility: Vedanta Institute; Medical Sciences
city: Bangalore
country: India
facility: Manipal Hospital
city: Banglore
country: India
facility: St.John's Medical College Hospital
city: Hubli
country: India
facility: Arthritis Super Speciality Centre
city: Hyderabad
country: India
facility: Care Institute of Medical Sciences
city: Nagpur
country: India
facility: Jasleen Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Yaacov
country: Israel
facility: Assaf Harofeh Medical Center
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Rheumatology
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Napoli
country: Italy
facility: Azienda Ospedaliera A. Cardarelli
state: Campania
city: Napoli
country: Italy
facility: Ospedale San Giovanni Bosco; Divisione di Reumatologia
state: Campania
city: Telese Terme
country: Italy
facility: Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese
state: Campania
city: Arenzano
country: Italy
facility: Ospedale La Colletta
state: Liguria
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
state: Liguria
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi
state: Lombardia
city: Catania
country: Italy
facility: Presidio Ospedaliero Vittorio Emanuele
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce
state: Toscana
city: Bauska
country: Latvia
facility: L.Krumina GP practice
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Liepaja
country: Latvia
facility: D.Saulite-Kandevica Private Practice
city: Riga
country: Latvia
facility: Clinic ORTO
city: Riga
country: Latvia
facility: Private Practice EHOKG
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital; Clinic Gailezers
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Alytus
country: Lithuania
facility: Alytus Regional S. Kudirkos Hospital, Public Institution
city: Klaipeda
country: Lithuania
facility: Klaipeda Seamen's Hospital, Public Institution
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital; Public Institution
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius District Central Outpatient Clinic, Public Institution
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Selayang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Penang
country: Malaysia
facility: Hospital Pulau Pinang
city: Selangor
country: Malaysia
facility: Sunway Medical Centre
city: Selangor
country: Malaysia
facility: Sime Darby Medical Centre
city: Tijuana
country: Mexico
facility: Centro de Investigacion del Noroeste SC
state: Baja California
city: Culiacán Rosales
country: Mexico
facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
state: Sinaloa
city: Mérida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud S.C.
state: Yucatan
city: Chihuahua
country: Mexico
facility: Hospital Christus Muguerza del Parque; Reumatologia
city: Chihuahua
country: Mexico
facility: Hospital CIMA Chihuahua; Reumatologia
city: Ciudad Obregon
country: Mexico
facility: Hospital Privado San Jose de Ciudad Obregon SA de CV
city: Cuernavaca
country: Mexico
facility: Private Practice Dr. Cortes
city: Delegacion Benito Juarez
country: Mexico
facility: RM pharma specialist SA de CV
city: Distrito Federal
country: Mexico
facility: Mentrials S.A. de C.V
city: Durango
country: Mexico
facility: Centro de Investigacion y Atencion Integral Durango CIAID
city: Guadalajara
country: Mexico
facility: Mundo Fisico
city: Guadalajara
country: Mexico
facility: Clinica Hospital Angeles Chapalita
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
city: Mexico City
country: Mexico
facility: Inst. Mexicano de Investigacion Clinica
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: Mexico Df
country: Mexico
facility: Hospital Mocel
city: Mexico
country: Mexico
facility: Mexico Centre for Clinical Research
city: Mexico
country: Mexico
facility: Comite Mexicano Para la Prevencion de Osteoporosis AC
city: Miexico City
country: Mexico
facility: Cliditer SA de CV
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo
city: San Luis Potosi S.L.P.
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
city: San Luis Potosí
country: Mexico
facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas
city: Amsterdam
country: Netherlands
facility: Jan Van Breemen Instituut
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis ; Dordwijk
city: Roosendaal
country: Netherlands
facility: Franciscus Ziekenhuis
city: Schiedam
country: Netherlands
facility: Vlietland Hospital
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital- North General Hospital
city: Cebu City
country: Philippines
facility: Chong Hua Hospital, Cebu City
city: Iloilo City
country: Philippines
facility: St. Paul Hospital; Arthritis Center
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony w Elblagu
city: Krakow
country: Poland
facility: Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. J. Dietla
city: Lublin
country: Poland
facility: NZOZ REUMED Sp. z o.o.
city: Nadarzyn
country: Poland
facility: Lecznica MAK-MED NZOZ
city: Szczecin
country: Poland
facility: SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego
city: Ustron
country: Poland
facility: Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: ARS Rheumatica Sp.z o. o
city: Wroclaw
country: Poland
facility: Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. I Cantacuzino
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie
city: Bucuresti
country: Romania
facility: Centrul de Boli Reumatismale Dr. Ioan Stoia
city: Cluj-Napoca
country: Romania
facility: Medex SRL
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii
city: Iasi
country: Romania
facility: CMI Dr.Ciornohuz Adriana
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare Iasi
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Sector 2
country: Romania
facility: Spitalul Clinic Colentina
city: Targoviste
country: Romania
facility: Spitalul Judetean de Urgenta Targoviste
city: Targu Mures
country: Romania
facility: Mediab SRL
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara
city: Barnaul
country: Russian Federation
facility: State institution of health care - Territorial Clinical Hospital
city: Barnaul
country: Russian Federation
facility: SEI of HPE "Altay State Medical University of Roszdrav"
city: Kazan
country: Russian Federation
facility: Scientific and research medical complex Your Health
city: Kemerovo
country: Russian Federation
facility: SIH Kemerovo Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Hospital No.4
city: Moscow
country: Russian Federation
facility: Scient Res Inst Rheumat RAMS
city: Moscow
country: Russian Federation
facility: Moscow State Medical Stomatological University
city: Moscow
country: Russian Federation
facility: Head Clinical Hospital of Internal Affair Ministry of Russia
city: Novosibirsk
country: Russian Federation
facility: MHI City Clinical Hospital#19
city: Novosibirsk
country: Russian Federation
facility: FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinincal Cardiology Dispensary
city: Saratov
country: Russian Federation
facility: State institution of healthcare "Regional hospital for war veterans"
city: St Petersburg
country: Russian Federation
facility: Leningradskaya Regional Clinical Hospital; Rheumatology Dept
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical Academy
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1
city: Yaroslavl
country: Russian Federation
facility: MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Niska Banja
country: Serbia
facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital; Rheumatology Unit
city: Diepkloof
country: South Africa
facility: Chris Hani Baragwanath Hospital; Rheumatology Department
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Academic Hospital
city: Pretoria
country: South Africa
facility: University of Pretoria; Clinical Trial Unit
city: Merida
country: Spain
facility: Hospital de Merida ;Servicio de Reumatologia
state: Badajoz
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: La Coruña
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofia; Servicio de Reumatologia
state: Madrid
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
state: Malaga
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Sevilla
city: S. Cristobal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Reumatologia
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: Vizcaya
city: Castellon
country: Spain
facility: Hospital General de Castellon; Servicio de Reumatologia
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Antalya
country: Turkey
facility: Akdeniz Univesity Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Erzurum
country: Turkey
facility: Ataturk University Med Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical Uni. Med. Fac.
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital; Rheumatology Dept
city: Cambridge
country: United Kingdom
facility: Addenbrooke's NHS Trust
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital; Rheumatology
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital; Rheumatology Department
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary NHS Trust
city: London
country: United Kingdom
facility: Royal London Hospital Outpatients Department
city: London
country: United Kingdom
facility: Whipps Cross Hospital; Rheumatology Dept
city: London
country: United Kingdom
facility: King'S College Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Rheumatology
city: Westcliffe-on-sea
country: United Kingdom
facility: Southend Hospital; Rheumatology Department
city: Wrightington
country: United Kingdom
facility: Wrightington Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.