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)
2 other identifiers
interventional
3,080
31 countries
428
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Aug 2011
Longer than P75 for phase_4 rheumatoid-arthritis
428 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedStudy Start
First participant enrolled
August 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2016
CompletedResults Posted
Study results publicly available
July 13, 2017
CompletedJuly 13, 2017
June 1, 2017
4.6 years
April 7, 2011
March 24, 2017
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (10)
The Time to First Occurrence of an Expanded CV Composite Endpoint
From baseline up to 4.9 years
Percentages of Participants With an Expanded CV Composite Endpoint
From baseline up to 4.9 years
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
From baseline up to 4.9 years
Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death
From baseline up to 4.9 years
- +5 more secondary outcomes
Study Arms (2)
Etanercept
ACTIVE COMPARATORTocilizumab
EXPERIMENTALInterventions
Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (428)
Uni Of Alabama,Birmingham; Medicine - Rheumatology
Birmingham, Alabama, 35294, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, 35406, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, 85253, United States
Sun Valley Arthritis Center
Peoria, Arizona, 85381, United States
Valley Arthritis Care
Phoenix, Arizona, 85027, United States
Advanced Arthritis Care & Research
Scottsdale, Arizona, 85258, United States
Camp Lowell Medical Specialists
Tucson, Arizona, 85715, United States
The University of Arizona
Tucson, Arizona, 85724, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
OrthoArkansas; Orthopedics & Sports Medicine
Little Rock, Arkansas, 72205, United States
Samy Metyas, MD, Inc
Covina, California, 91723, United States
Talbert Medical Group
Huntington Beach, California, 92646, United States
Allergy & Rheumatology Medical Clinic, Inc
La Jolla, California, 92037, United States
Valerius Medical Group
Los Alamitos, California, 90720, United States
Clinical Interventions Research Institute
Mission Viejo, California, 92692, United States
Dr. Brigid Freyne, MD
Murrieta, California, 92563, United States
Sharp Rees-Stealy Medical Group
Poway, California, 92064, United States
San Diego Arthritis Med Clnc
San Diego, California, 92108, United States
Purushotham & Akther Kotha Inc
San Diego, California, 92120, United States
C Michael Neuwelt MD Inc
San Leandro, California, 94578, United States
Pacific Arthritis Ctr Med Grp
Santa Maria, California, 93454, United States
Orrin M. Troum, Md
Santa Monica, California, 90404, United States
Harbor UCLA Medical Center
Torrance, California, 90509, United States
Inland Rheumatology; Clinical Trials, Inc.
Upland, California, 91786, United States
Medvin Clinical Research
Whittier, California, 90606, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, 80920, United States
Joao Nascimento
Bridgeport, Connecticut, 06606, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Arthritis & Osteoporosis Center Pc
Hamden, Connecticut, 06518, United States
ZASA Clinical Research
Boynton Beach, Florida, 33472, United States
DC Health Clinic
Coral Gables, Florida, 33134, United States
Tsai, Yong
Daytona Beach, Florida, 32117, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216, United States
Pharmax Research Clinic Inc.
Miami, Florida, 33126, United States
Arthritis/Osteoporosis Treatment Center
Orange Park, Florida, 32073, United States
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Baptist Hospital Clinical Research
Pensacola, Florida, 32501, United States
Lovelace Scientific Resources
Sarasota, Florida, 34292, United States
Centre for Arthritis and Rheumatic Diseases
South Miami, Florida, 33143, United States
Pinellas Medical Research, LLC
St. Petersburg, Florida, 33708, United States
SW Florida Clinical Research
Tampa, Florida, 33609, United States
Healthpoint Medical group, Inc
Tampa, Florida, 33614, United States
Emory Uni ; Division of Rheumatology
Atlanta, Georgia, 30303, United States
Arthritis & Rheumatology of Georgia
Atlanta, Georgia, 30342, United States
North Georgia Rheumatology
Duluth, Georgia, 30096, United States
Harbin Clinic
Rome, Georgia, 30165, United States
St. Joseph'S/Candler Health System, Inc.; Office of Research
Savannah, Georgia, 31405, United States
Sonora Clinical Research
Boise, Idaho, 83702, United States
St. Luke's Intermountain Research Center
Boise, Idaho, 83702, United States
Selah Medical Ctr
Boise, Idaho, 83704, United States
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814, United States
Idaho Arthritis Center
Meridian, Idaho, 83642, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Apex Medical Research, AMR, Inc.
Chicago, Illinois, 60616, United States
Methodist Medical Center of Ilinois
Peoria, Illinois, 61602, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804, United States
Diagnostic Rheumatology & Research
Indianapolis, Indiana, 46227, United States
Memorial Medical Group Clinical Research
South Bend, Indiana, 46601, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Research Integrity
Owensboro, Kentucky, 42303, United States
Arthritis & Diabetes Clinic, Inc
Monroe, Louisiana, 71203, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
Rheumatology Associates of Baltimore
Baltimore, Maryland, 21286, United States
Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, 21740, United States
Center For Rheumatology & Bone Research
Wheaton, Maryland, 20902, United States
Phase Iii Clinical Research
Fall River, Massachusetts, 02720, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Hurley Research Center
Flint, Michigan, 48503, United States
Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan, 49009, United States
Advanced Rheumatology, PC
Lansing, Michigan, 48910, United States
Northern Michigan Regional Hospital
Petoskey, Michigan, 49770, United States
St. Paul Rheumatology
Eagan, Minnesota, 55121, United States
Va Medical Center
Minneapolis, Minnesota, 55417, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Jackson Arthritis Clinic
Flowood, Mississippi, 39232, United States
North Mississippi Med Clinics, Inc.
Tupelo, Mississippi, 38801, United States
Glacier View Research Institute
Kalispell, Montana, 59901, United States
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 68198, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Innovative Health Research
Las Vegas, Nevada, 89128, United States
Dartmouth-Hitchcock Medical Center, Rheumatology 5C
Lebanon, New Hampshire, 03756, United States
Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire, 03060, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Rheumatology Associates Of New Jersey
Teaneck, New Jersey, 07666, United States
Arthritis Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, 08043, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, 88011, United States
Arthritis & Osteoporosis Medical Associates, Pllc
Brooklyn, New York, 11201, United States
SUNY Downstate Medical Center.
Brooklyn, New York, 11203, United States
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, 11758, United States
Southern Tier Arthritis & Rheumatism
Olean, New York, 14760, United States
Arthritis Health Associates; Clinical Research
Syracuse, New York, 13210, United States
Asheville Arthritis & Osteoporosis Center, PA
Asheville, North Carolina, 28803, United States
Joint & Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Carolina Bone & Joint P.A.
Charlotte, North Carolina, 28210, United States
Durham Rheumatology
Durham, North Carolina, 27704, United States
PMG Research of Hickory LLC
Hickory, North Carolina, 28602, United States
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, 27617, United States
Specialty Medical Clinic and Research Center
Sanford, North Carolina, 27330, United States
Carolina Arthritis Associates, Pa
Wilmington, North Carolina, 28401, United States
Trinity Health Center
Minot, North Dakota, 58701, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44109, United States
Ohio State Univ Med Center
Columbus, Ohio, 43210, United States
Columbus Arthritis Center
Columbus, Ohio, 43215, United States
Clinical Research Source, Inc.
Toledo, Ohio, 43606, United States
Toledo Clinic
Toledo, Ohio, 43623, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Ilumina Clinical Associates
Indiana, Pennsylvania, 15701, United States
PMA Medical Specialists
Limerick, Pennsylvania, 19468, United States
Pivotal Clinical Research, Llc
Perkasie, Pennsylvania, 18944, United States
Arthritis Group
Philadelphia, Pennsylvania, 19152, United States
University of Pittsburgh Medical Center Health System; Infectious Disease
Pittsburgh, Pennsylvania, 15213-2582, United States
Allegheny Rheumatology
Wexford, Pennsylvania, 15090, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, 19610, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Columbia Arthritis Center (Partnership Practice)
Columbia, South Carolina, 29204, United States
South Carolina Research Center
Myrtle Beach, South Carolina, 29572, United States
Brown Clinic
Watertown, South Dakota, 57201, United States
Ramesh Gupta - PP
Memphis, Tennessee, 38119, United States
Amarillo Center For Clinical Research
Amarillo, Texas, 79124, United States
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, 78404, United States
Metroplex Clinical Research
Dallas, Texas, 75231, United States
Leading Edge Research, PA; Office of Dr. Burbano
Fort Worth, Texas, 76109, United States
Rheumatic Disease Clin Res Ctr
Houston, Texas, 77004, United States
Houston Inst. For Clinical Research
Houston, Texas, 77074, United States
Southwest Rheumatology
Mesquite, Texas, 75150, United States
Leading Edge Research, PA; Office of Dr. Burbano
Richardson, Texas, 75080, United States
Texas Arthritis Research Center
San Antonio, Texas, 78217, United States
Arthritis & Osteoporosis Clinic
Waco, Texas, 76710, United States
Arthritis and Rheumatic Disease Associates
Burke, Virginia, 22015, United States
Sentara Medical Group
Norfolk, Virginia, 23510, United States
Apex Clinical Research
Kennewick, Washington, 99336, United States
Seattle Rheumatology Associates
Seattle, Washington, 98104, United States
Office of George Krick, Md
Tacoma, Washington, 98405, United States
Rheum & Pulmonary Clinic
Beckley, West Virginia, 25801, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Arthritis Centre; Suite 103
Racine, Wisconsin, 53406, United States
Centro de Investigaciones Reumatologicas y Osteologicas
Buenos Aires, 1111, Argentina
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
CEIM Consultorios Especializados en Investigaciones Médicas
Buenos Aires, C1117ABK, Argentina
APRILLUS
Buenos Aires, C1194AAO, Argentina
Instituto centenario
Buenos Aires, C1204AAD, Argentina
Fundación CIDEA
Buenos Aires, C1425DTG, Argentina
Atencion Integral En Reumatologia Buenos Aires
Buenos Aires, C1426AAL, Argentina
CEMIC
Buenos Aires, C1431FWO, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, C1221ADC, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Hospital Privado Cordoba
Cordoba Pcia, 5016, Argentina
Instituto Reumatológico Strusberg
Córdoba, 5000, Argentina
Hospital Italiano de Cordoba
Córdoba, X5004BAL, Argentina
Hospital Municipal Nuestra Sra. de Lujan
Luján, 6700, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
Sanatorio Parque de Rosario
Rosario, S2000DSV, Argentina
Instituto Centralizado de Asistencia e Investigaci
Rosario, Santa Fe, S2000PBJ, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, 5400, Argentina
Centro de Investigaciones Médicas - CIM
San Juan Bautista, 1888, Argentina
Centro de Investigaciones Reumatologicas Tucuman
San Miguel de Tucumán, 4000, Argentina
Centro Médico Privado de Reumatología
San Miguel de Tucumán, T4000AXL, Argentina
Lkh-Univ. Klinikum Graz
Graz, 8036, Austria
Landesklinikum Weinviertel Stockerau; Rheumatologie
Stockerau, 2000, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Rheuma-Zentrum Favoriten Wien
Vienna, 1100, Austria
Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A
Vienna, 1130, Austria
CHU St Pierre (St Pierre)
Brussels, 1000, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
AZ Groeninge (Vercruysselaan)
Kortrijk, 8500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
University Clinical Center of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
University Clinic Ctr Sarajevo
Sarajevo, 71 000, Bosnia and Herzegovina
General Hospital Prim.dr.Abdulah Nakas
Sarajevo, 71000, Bosnia and Herzegovina
Uni Hospital Center Tuzla
Tuzla, 75000, Bosnia and Herzegovina
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
The Medical Arts Health Research Group
Powell River, British Columbia, V8A 3B6, Canada
Baker, Milton F.
Victoria, British Columbia, V8P 5P6, Canada
Nexus Clinical Research Centre
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
St. Clare'S Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Arthur Karasik, MD
Etobicoke, Ontario, M9C 5N2, Canada
Charlton Medical Center
Hamilton, Ontario, L8N 1Y2, Canada
K-W Musculoskeletal Research
Kitchener, Ontario, N2M 5N6, Canada
St. Joseph's Hospital
London, Ontario, N6A 4V2, Canada
Credit Valley, Rheumatology
Mississauga, Ontario, L5M 2V8, Canada
Niagara Peninsula Arthritis Centre
St. Catharines, Ontario, L2N 7E4, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1Z5, Canada
Institut de Rhumatologie de Montreal
Montreal, Quebec, H2L 1S6, Canada
Groupe de Recherche En Rhumatologie Et Maladies Osseuses
Québec, Quebec, G1V 3M7, Canada
Chus Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Centre Re Recherche Saint-Louis
Québec, G1W 4R4, Canada
Hospital San Juan de Dios La Serena
La Serena, 1700000, Chile
Centro Medico Prosalud
Santiago, 7500000, Chile
Interin
Santiago, 7500035, Chile
Centro de Estudios Reumatológicos
Santiago, 7501126, Chile
Hospital Clinico Pontificia Universidad Catolica de Chile
Santiago, 8320112, Chile
Centro de Investigacion Clinica del Sur
Temuco, 4780000, Chile
Clinica Alemana de Temuco
Temuco, 4780000, Chile
Hospital Clinico Viña del Mar- Oncovida
Viña del Mar, 2520612, Chile
Centro de Estudios Clinicos V Region Limitada
Viña del Mar, Chile
General Hospital Karlovac
Karlovac, 47000, Croatia
Special Hospital for Medical Rehabilitation
Krapinske Toplice, 49217, Croatia
Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology
Rijeka, 51000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Universtiy Hospital Dubrava
Zagreb, 10000, Croatia
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Revmatologicka ambulance
Bruntál, 792 01, Czechia
Revmatologicka Ambulance
Hlučín, 748 01, Czechia
Interni a revmatologicka ordinace
Hostivice, 253 01, Czechia
Revmatologicka a-interni ambulance
Kladno, 272 01, Czechia
Revmatologie MUDr. Klara Sirova s.r.o.
Ostrava - Moravska Ostrava, 702 00, Czechia
Revmatologicky Ustav
Prague, 128 50, Czechia
Revmatologicka ambulance
Prague, 140 00, Czechia
Fakultni Thomayerova nemocnice s poliklinikou
Prague, 140 59, Czechia
Artroscan s.r.o.
Sokolov, 356 01, Czechia
Revmatologicka Ambulance-Terezin
Terezín, 411 55, Czechia
PV - Medical, s.r.o.
Zlín, 748 01, Czechia
Hospital Clínica Santa Inés
Cuenca, 101168, Ecuador
Centro de Reumatología y Rehabilitación
Guayaquil, 593, Ecuador
OMNI Hospital
Guayaquil, 593, Ecuador
Centro Medico Alcivar 4
Guayaquil, EC090114, Ecuador
Centro Medico Picasso
Quito, 005932, Ecuador
Novaclinica Santa Cecilia; Reumatology
Quito, EC170517, Ecuador
CHU d'Amiens Hôpital Nord; Pharmacie Clinique
Amiens, 80054, France
Groupe Hospitalier Pellegrin
Bordeaux, 33000, France
CHU Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
CHU Grenoble Sud
Échirolles, 38434, France
Hôpital Edouard Herriot; Service de Rhumatologie
Lyon, 69003, France
CHR Orleans, Hopital Madeleine
Orléans, 45067, France
Hôpital Saint-Antoine; Service de Psychiatrie
Paris, 75571, France
Groupe Hospitalier Pitie-Salpetriere
Paris, 75651, France
Hopital Cochin; Gastro Enterologie
Paris, 75679, France
Hôpital Sud - CHU de Rennes
Rennes, 35033, France
Hôpital Victor Provo
Roubaix, 59056, France
CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie
Rouen, 76031, France
CHU Saint-Etienne, Hopital Bellevue
Saint-Etienne, 42055, France
Hôpital General - CHRU de Dijon
Strasbourg, 67098, France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Toulouse, 31059, France
Charité Universitaetsmedizin Berlin, Campus Charité Mitte
Berlin, 10117, Germany
Schlosspark-Klinik
Berlin, 14059, Germany
Universitätsklinikum Köln, Klinik I für Innere Medizin
Cologne, 50937, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Erlangen; Augenklinik
Erlangen, 91054, Germany
Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN
Erlangen, 91056, Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60528, Germany
Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie
Hamburg, 20251, Germany
Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie
Hamburg, 22081, Germany
Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus
Herne, 44649, Germany
Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie
Hildesheim, 31134, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Ludwig Maximilians; Universitaet
München, 80337, Germany
Praxiszentrum St. Bonifatius
München, 81541, Germany
Rheumatologische Gemeinschaftspraxis
Osnabrück, 49074, Germany
Evangelisches Fachkrankenhaus
Ratingen, 40882, Germany
Laiko General Hospital Athen
Athens, 115 27, Greece
Euroclinic of Athens; Internal Medicine & Immunology Dept.
Athens, 15121, Greece
University General Hospital of Heraklion
Crete, 71110, Greece
University General Hospital of Larissa; Rheumatology Unit
Larissa, 411 10, Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki, 54 642, Greece
Euromedica Kyanous Stavros General Hospital
Thessaloniki, 546 36, Greece
424 Military Training Hospital-Egnatia
Thessaloniki, Greece
Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály
Budapest, 1027, Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Synexus Magyarorszag Kft
Budapest, 1036, Hungary
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
Debrecen, 4032, Hungary
Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.
Eger, 3300, Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula, 5700, Hungary
Varosi Korhaz-Rendelointezet
Mór, 8060, Hungary
Clinfan Szolgaltato Kft.
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, 8000, Hungary
Zala Megyei Korhaz; Reumatologia
Zalaegerszeg, 8901, Hungary
Shalby Hospital Limited
Ahmedabad, Gujarat, 380015, India
Vedanta Institute; Medical Sciences
Ahmedabad, 380009, India
Manipal Hospital
Bangalore, 560017, India
St.John's Medical College Hospital
Banglore, 560034, India
Arthritis Super Speciality Centre
Hubli, 580020, India
Care Institute of Medical Sciences
Hyderabad, 500034, India
Jasleen Hospital
Nagpur, 440010, India
Barzilai Medical Center
Ashkelon, 78278, Israel
Assaf Harofeh Medical Center
Beer Yaacov, 6093000, Israel
The Lady Davis Carmel Medical Center
Haifa, 34362, Israel
Chaim Sheba Medical Center; Rheumatology
Ramat Gan, 5262000, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera A. Cardarelli
Napoli, Campania, 80131, Italy
Ospedale San Giovanni Bosco; Divisione di Reumatologia
Napoli, Campania, 80144, Italy
Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese
Telese Terme, Campania, 82037, Italy
Ospedale La Colletta
Arenzano, Liguria, 16011, Italy
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, 16132, Italy
Ospedali Riuniti di Bergamo
Bergamo, Lombardy, 24128, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, 21100, Italy
Presidio Ospedaliero Vittorio Emanuele
Catania, Sicily, 95124, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141, Italy
Ospedale Misericordia e Dolce
Prato, Tuscany, 59100, Italy
L.Krumina GP practice
Bauska, 3901, Latvia
Daugavpils Regional Hospital
Daugavpils, 5417, Latvia
D.Saulite-Kandevica Private Practice
Liepāja, 3400, Latvia
Clinic ORTO
Riga, 1005, Latvia
Private Practice EHOKG
Riga, 1021, Latvia
Riga East Clinical University Hospital; Clinic Gailezers
Riga, LV 1002, Latvia
P. Stradins Clinical University Hospital
Riga, LV-1002, Latvia
Alytus Regional S. Kudirkos Hospital, Public Institution
Alytus, 62114, Lithuania
Klaipeda Seamen's Hospital, Public Institution
Klaipėda, 92288, Lithuania
Klaipeda University Hospital; Public Institution
Klaipėda, 92288, Lithuania
Siauliai Republican Hospital Public Institution
Šiauliai, 76231, Lithuania
Vilnius District Central Outpatient Clinic, Public Institution
Vilnius, 06122, Lithuania
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Sunway Medical Centre
Kuala Selangor, Selangor, 46150, Malaysia
Sime Darby Medical Centre
Kuala Selangor, Selangor, 47500, Malaysia
Hospital Selayang
Kuala Lumpur, 68100, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Centro de Investigacion del Noroeste SC
Tijuana, Estado de Baja California, 22010, Mexico
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Culiacán, Sinaloa, 80000, Mexico
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, 97000, Mexico
Hospital Christus Muguerza del Parque; Reumatologia
Chihuahua City, 31000, Mexico
Hospital CIMA Chihuahua; Reumatologia
Chihuahua City, 31238, Mexico
Hospital Privado San Jose de Ciudad Obregon SA de CV
Ciudad Obregón, 85000, Mexico
Private Practice Dr. Cortes
Cuernavaca, 62270, Mexico
RM pharma specialist SA de CV
Delegacion Benito Juarez, 03100, Mexico
Mentrials S.A. de C.V
Distrito Federal, 06600, Mexico
Centro de Investigacion y Atencion Integral Durango CIAID
Durango, 34080, Mexico
Mundo Fisico
Guadalajara, 44500, Mexico
Clinica Hospital Angeles Chapalita
Guadalajara, 45040, Mexico
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
Mexicali, 21100, Mexico
Inst. Mexicano de Investigacion Clinica
Mexico City, 06700, Mexico
Hospital Mocel
Mexico City, 11850, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
Mexico Centre for Clinical Research
México, 03100, Mexico
Comite Mexicano Para la Prevencion de Osteoporosis AC
México, 06100, Mexico
Cliditer SA de CV
Miexico City, 06700, Mexico
Hospital Universitario de Saltillo
Saltillo, 25000, Mexico
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosi S.l.p., 78240, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis Potosí City, 78200, Mexico
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
Torreón, 27000, Mexico
Jan Van Breemen Instituut
Amsterdam, 1056 AB, Netherlands
Albert Schweitzer Ziekenhuis ; Dordwijk
Dordrecht, 3318AT, Netherlands
Franciscus Ziekenhuis
Roosendaal, 4708 AE, Netherlands
Vlietland Hospital
Schiedam, 3118 JH, Netherlands
Cebu Doctors' University Hospital- North General Hospital
Cebu City, 6000, Philippines
Chong Hua Hospital, Cebu City
Cebu City, 6000, Philippines
St. Paul Hospital; Arthritis Center
Iloilo City, 5000, Philippines
Mary Mediatrix Medical Center
Lipa City, 4217, Philippines
Makati Medical Center
Makati City, 1229, Philippines
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Bydgoszcz, 85-168, Poland
Wojewodzki Szpital Zespolony w Elblagu
Elblag, 82-300, Poland
Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii
Krakow, 30-119, Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, 31-121, Poland
NZOZ REUMED Sp. z o.o.
Lublin, 20-607, Poland
Lecznica MAK-MED NZOZ
Nadarzyn, 05-830, Poland
SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego
Szczecin, 71-252, Poland
Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny
Ustroń, 43-450, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, 02-118, Poland
ARS Rheumatica Sp.z o. o
Warsaw, 02-653, Poland
Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego
Wroclaw, 50-556, Poland
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, 500365, Romania
Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie
Bucharest, 011172, Romania
Spitalul Clinic Dr. I Cantacuzino
Bucharest, 020475, Romania
Centrul de Boli Reumatismale Dr. Ioan Stoia
Bucharest, 020983, Romania
Medex SRL
Cluj-Napoca, 400130, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii
Cluj-Napoca, 400349, Romania
CMI Dr.Ciornohuz Adriana
Iași, 700127, Romania
Spitalul Clinic de Recuperare Iasi
Iași, 700656, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
Spitalul Clinic Colentina
Sector 2, 020125, Romania
Spitalul Judetean de Urgenta Targoviste
Târgovişte, 130083, Romania
Mediab SRL
Târgu Mureş, 540142, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300194, Romania
State institution of health care - Territorial Clinical Hospital
Barnaul, 656024, Russia
SEI of HPE "Altay State Medical University of Roszdrav"
Barnaul, 656038, Russia
Scientific and research medical complex Your Health
Kazan', 420097, Russia
SIH Kemerovo Regional Clinical Hospital
Kemerovo, 650002, Russia
City Hospital No.4
Moscow, 115093, Russia
Scient Res Inst Rheumat RAMS
Moscow, 115522, Russia
Moscow State Medical Stomatological University
Moscow, 121374, Russia
Head Clinical Hospital of Internal Affair Ministry of Russia
Moscow, 123060, Russia
MHI City Clinical Hospital#19
Novosibirsk, 630068, Russia
FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS
Novosibirsk, 630099, Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, 390026, Russia
Leningradskaya Regional Clinical Hospital; Rheumatology Dept
Saint Petersburg, 194291, Russia
State institution of healthcare "Regional hospital for war veterans"
Saratov, 410002, Russia
Stavropol State Medical Academy
Stavropol, 355017, Russia
Tomsk Regional Clinical Hospital
Tomsk, 634063, Russia
Voronezh Regional Clinical Hospital #1
Voronezh, 394066, Russia
MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant
Yaroslavl, 150007, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11040, Serbia
Clinical Center Bezanijska Kosa
Belgrade, 11070, Serbia
Institute of Rheumatology and Cardiovascular Diseases; Rheumatology
Niška Banja, 18205, Serbia
Groote Schuur Hospital; Rheumatology Unit
Cape Town, 7925, South Africa
Chris Hani Baragwanath Hospital; Rheumatology Department
Diepkloof, 1862, South Africa
Charlotte Maxeke Academic Hospital
Johannesburg, 2193, South Africa
University of Pretoria; Clinical Trial Unit
Pretoria, 0002, South Africa
Hospital de Merida ;Servicio de Reumatologia
Mérida, Badajoz, 06800, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Sierrallana
Torrelavega, Cantabria, 39300, Spain
Hospital General de Castellon; Servicio de Reumatologia
Castellon, Castellon, 12004, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Infanta Sofia; Servicio de Reumatologia
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Malaga, 29009, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071, Spain
Hospital Universitario de Canarias
S. Cristobal de La Laguna, Tenerife, 38320, Spain
Hospital de Cruces; Servicio de Reumatologia
Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Gregorio Marañon
Madrid, 28007, Spain
Akdeniz Univesity Medical Faculty
Antalya, 07058, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Ataturk University Med Faculty
Erzurum, 25050, Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, 61100, Turkey (Türkiye)
Selly Oak Hospital; Rheumatology Dept
Birmingham, B29 6JD, United Kingdom
Addenbrooke's NHS Trust
Cambridge, CB2 0QQ, United Kingdom
Cannock Chase Hospital; Rheumatology
Cannock, WS11 5XY, United Kingdom
Russells Hall Hospital; Rheumatology Department
Dudley, DY1 2HQ, United Kingdom
Leicester Royal Infirmary NHS Trust
Leicester, LE1 5WW, United Kingdom
Royal London Hospital Outpatients Department
London, E1 1BB, United Kingdom
Whipps Cross Hospital; Rheumatology Dept
London, E11 1NR, United Kingdom
King'S College Hospital
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
Southampton General Hospital; Rheumatology
Southampton, SO16 6YD, United Kingdom
Southend Hospital; Rheumatology Department
Westcliffe-on-sea, SS0 0RY, United Kingdom
Wrightington Hospital
Wrightington, WN6 9EP, United Kingdom
Related Publications (1)
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.
PMID: 31469238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 8, 2011
Study Start
August 2, 2011
Primary Completion
March 25, 2016
Study Completion
March 25, 2016
Last Updated
July 13, 2017
Results First Posted
July 13, 2017
Record last verified: 2017-06