AzTrials
AzTrials

Rheumatoid ArthritisPhase 4NCT01331837

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

A Phase 4 study testing Etanercept and Tocilizumab in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 428 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Etanercept and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,080 participants
Where
428 sitesin 31 countries
Study dates
2 Aug 2011to 25 Mar 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

428 sites in 31 countries.

428 sites in 31 countries

United States143 sites

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico, 87102

  • Amarillo Center For Clinical Research

    Amarillo, Texas, 79124

  • Asheville Arthritis & Osteoporosis Center, PA

    Asheville, North Carolina, 28803

  • Emory Uni ; Division of Rheumatology

    Atlanta, Georgia, 30303

  • Arthritis & Rheumatology of Georgia

    Atlanta, Georgia, 30342

  • Rheumatology Associates of Baltimore

    Baltimore, Maryland, 21286

  • Rheum & Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Uni Of Alabama,Birmingham; Medicine - Rheumatology

    Birmingham, Alabama, 35294

  • Sonora Clinical Research

    Boise, Idaho, 83702

  • St. Luke's Intermountain Research Center

    Boise, Idaho, 83702

  • Selah Medical Ctr

    Boise, Idaho, 83704

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • ZASA Clinical Research

    Boynton Beach, Florida, 33472

  • Joao Nascimento

    Bridgeport, Connecticut, 06606

  • Arthritis & Osteoporosis Medical Associates, Pllc

    Brooklyn, New York, 11201

  • SUNY Downstate Medical Center.

    Brooklyn, New York, 11203

  • Arthritis and Rheumatic Disease Associates

    Burke, Virginia, 22015

  • Joint & Muscle Research Institute

    Charlotte, North Carolina, 28204

  • Carolina Bone & Joint P.A.

    Charlotte, North Carolina, 28210

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Apex Medical Research, AMR, Inc.

    Chicago, Illinois, 60616

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45219

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44109

  • Coeur D'Alene Arthritis Clinic

    Coeur d'Alene, Idaho, 83814

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

    Colorado Springs, Colorado, 80920

  • Columbia Arthritis Center (Partnership Practice)

    Columbia, South Carolina, 29204

  • Ohio State Univ Med Center

    Columbus, Ohio, 43210

  • Columbus Arthritis Center

    Columbus, Ohio, 43215

  • DC Health Clinic

    Coral Gables, Florida, 33134

  • Adriana Pop-Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Samy Metyas, MD, Inc

    Covina, California, 91723

  • Metroplex Clinical Research

    Dallas, Texas, 75231

  • Tsai, Yong

    Daytona Beach, Florida, 32117

  • North Georgia Rheumatology

    Duluth, Georgia, 30096

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Durham Rheumatology

    Durham, North Carolina, 27704

  • St. Paul Rheumatology

    Eagan, Minnesota, 55121

  • Phase Iii Clinical Research

    Fall River, Massachusetts, 02720

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • Hurley Research Center

    Flint, Michigan, 48503

  • Jackson Arthritis Clinic

    Flowood, Mississippi, 39232

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana, 46804

  • Leading Edge Research, PA; Office of Dr. Burbano

    Fort Worth, Texas, 76109

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona, 85306

  • Osteoporosis & Clinical Trials Center

    Hagerstown, Maryland, 21740

  • Arthritis & Osteoporosis Center Pc

    Hamden, Connecticut, 06518

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • PMG Research of Hickory LLC

    Hickory, North Carolina, 28602

  • Rheumatic Disease Clin Res Ctr

    Houston, Texas, 77004

  • Houston Inst. For Clinical Research

    Houston, Texas, 77074

  • Talbert Medical Group

    Huntington Beach, California, 92646

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama, 35801

  • Ilumina Clinical Associates

    Indiana, Pennsylvania, 15701

  • Diagnostic Rheumatology & Research

    Indianapolis, Indiana, 46227

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32216

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Rheumatology, P.C.; Medical Arts Building

    Kalamazoo, Michigan, 49009

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Apex Clinical Research

    Kennewick, Washington, 99336

  • Allergy & Rheumatology Medical Clinic, Inc

    La Jolla, California, 92037

  • Advanced Rheumatology, PC

    Lansing, Michigan, 48910

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Innovative Health Research

    Las Vegas, Nevada, 89128

  • Dartmouth-Hitchcock Medical Center, Rheumatology 5C

    Lebanon, New Hampshire, 03756

  • PMA Medical Specialists

    Limerick, Pennsylvania, 19468

  • OrthoArkansas; Orthopedics & Sports Medicine

    Little Rock, Arkansas, 72205

  • Valerius Medical Group

    Los Alamitos, California, 90720

  • Ramesh Gupta - PP

    Memphis, Tennessee, 38119

  • Idaho Arthritis Center

    Meridian, Idaho, 83642

  • Southwest Rheumatology

    Mesquite, Texas, 75150

  • Pharmax Research Clinic Inc.

    Miami, Florida, 33126

  • Va Medical Center

    Minneapolis, Minnesota, 55417

  • Trinity Health Center

    Minot, North Dakota, 58701

  • Clinical Interventions Research Institute

    Mission Viejo, California, 92692

  • Arthritis & Diabetes Clinic, Inc

    Monroe, Louisiana, 71203

  • Dr. Brigid Freyne, MD

    Murrieta, California, 92563

  • South Carolina Research Center

    Myrtle Beach, South Carolina, 29572

  • Nashua Rheumatology - Foundation Medical Partners

    Nashua, New Hampshire, 03060

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • Sentara Medical Group

    Norfolk, Virginia, 23510

  • DiGiovanna Inst for Med Ed&Res

    North Massapequa, New York, 11758

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Southern Tier Arthritis & Rheumatism

    Olean, New York, 14760

  • Univ of Nebraska Medical Ctr

    Omaha, Nebraska, 68198

  • Arthritis/Osteoporosis Treatment Center

    Orange Park, Florida, 32073

  • Research Integrity

    Owensboro, Kentucky, 42303

  • Arthritis Rsrch of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Arizona Arthritis & Rheumatology Research, Pllc

    Paradise Valley, Arizona, 85253

  • Baptist Hospital Clinical Research

    Pensacola, Florida, 32501

  • Sun Valley Arthritis Center

    Peoria, Arizona, 85381

  • Methodist Medical Center of Ilinois

    Peoria, Illinois, 61602

  • Pivotal Clinical Research, Llc

    Perkasie, Pennsylvania, 18944

  • Northern Michigan Regional Hospital

    Petoskey, Michigan, 49770

  • Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Valley Arthritis Care

    Phoenix, Arizona, 85027

  • University of Pittsburgh Medical Center Health System; Infectious Disease

    Pittsburgh, Pennsylvania, 15213-2582

  • Sharp Rees-Stealy Medical Group

    Poway, California, 92064

  • Arthritis Centre; Suite 103

    Racine, Wisconsin, 53406

  • Shanahan Rheumatology & Immunology, PLLC

    Raleigh, North Carolina, 27617

  • Leading Edge Research, PA; Office of Dr. Burbano

    Richardson, Texas, 75080

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Harbin Clinic

    Rome, Georgia, 30165

  • Texas Arthritis Research Center

    San Antonio, Texas, 78217

  • San Diego Arthritis Med Clnc

    San Diego, California, 92108

  • Purushotham & Akther Kotha Inc

    San Diego, California, 92120

  • C Michael Neuwelt MD Inc

    San Leandro, California, 94578

  • Specialty Medical Clinic and Research Center

    Sanford, North Carolina, 27330

  • Pacific Arthritis Ctr Med Grp

    Santa Maria, California, 93454

  • Orrin M. Troum, Md

    Santa Monica, California, 90404

  • Lovelace Scientific Resources

    Sarasota, Florida, 34292

  • St. Joseph'S/Candler Health System, Inc.; Office of Research

    Savannah, Georgia, 31405

  • Advanced Arthritis Care & Research

    Scottsdale, Arizona, 85258

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104

  • Memorial Medical Group Clinical Research

    South Bend, Indiana, 46601

  • Centre for Arthritis and Rheumatic Diseases

    South Miami, Florida, 33143

  • Pinellas Medical Research, LLC

    St. Petersburg, Florida, 33708

  • Arthritis Health Associates; Clinical Research

    Syracuse, New York, 13210

  • Office of George Krick, Md

    Tacoma, Washington, 98405

  • SW Florida Clinical Research

    Tampa, Florida, 33609

  • Healthpoint Medical group, Inc

    Tampa, Florida, 33614

  • Rheumatology Associates Of New Jersey

    Teaneck, New Jersey, 07666

  • Clinical Research Source, Inc.

    Toledo, Ohio, 43606

  • Toledo Clinic

    Toledo, Ohio, 43623

  • Harbor UCLA Medical Center

    Torrance, California, 90509

  • Camp Lowell Medical Specialists

    Tucson, Arizona, 85715

  • The University of Arizona

    Tucson, Arizona, 85724

  • North Mississippi Med Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Clinical and Translational Research Center of Alabama, PC

    Tuscaloosa, Alabama, 35406

  • Inland Rheumatology; Clinical Trials, Inc.

    Upland, California, 91786

  • Arthritis Rheumatic & Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Arthritis & Osteoporosis Clinic

    Waco, Texas, 76710

  • Brown Clinic

    Watertown, South Dakota, 57201

  • Allegheny Rheumatology

    Wexford, Pennsylvania, 15090

  • Center For Rheumatology & Bone Research

    Wheaton, Maryland, 20902

  • Medvin Clinical Research

    Whittier, California, 90606

  • Carolina Arthritis Associates, Pa

    Wilmington, North Carolina, 28401

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

  • Clinical Research Center of Reading

    Wyomissing, Pennsylvania, 19610

  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Mexico23 sites

  • Hospital Christus Muguerza del Parque; Reumatologia

    Chihuahua City, 31000

  • Hospital CIMA Chihuahua; Reumatologia

    Chihuahua City, 31238

  • Hospital Privado San Jose de Ciudad Obregon SA de CV

    Ciudad Obregón, 85000

  • Private Practice Dr. Cortes

    Cuernavaca, 62270

  • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

    Culiacán, Sinaloa, 80000

  • RM pharma specialist SA de CV

    Delegacion Benito Juarez, 03100

  • Mentrials S.A. de C.V

    Distrito Federal, 06600

  • Centro de Investigacion y Atencion Integral Durango CIAID

    Durango, 34080

  • Mundo Fisico

    Guadalajara, 44500

  • Clinica Hospital Angeles Chapalita

    Guadalajara, 45040

  • Unidad de Atencion Medica e Investigacion en Salud S.C.

    Mérida, Yucatán, 97000

  • Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

    Mexicali, 21100

  • Mexico Centre for Clinical Research

    México, 03100

  • Comite Mexicano Para la Prevencion de Osteoporosis AC

    México, 06100

  • Inst. Mexicano de Investigacion Clinica

    Mexico City, 06700

  • Hospital Mocel

    Mexico City, 11850

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico City, 14080

  • Cliditer SA de CV

    Miexico City, 06700

  • Hospital Universitario de Saltillo

    Saltillo, 25000

  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

    San Luis Potosí City, 78200

  • Hospital Central Dr. Ignacio Morones Prieto

    San Luis Potosi S.l.p., 78240

  • Centro de Investigacion del Noroeste SC

    Tijuana, Estado de Baja California, 22010

  • Unidad de Enfermedades Reumaticas y Cronicodegenerativas

    Torreón, 27000

Other trials in Mexico

Argentina21 sites

  • Centro de Investigaciones Reumatologicas y Osteologicas

    Buenos Aires, 1111

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • CEIM Consultorios Especializados en Investigaciones Médicas

    Buenos Aires, C1117ABK

  • APRILLUS

    Buenos Aires, C1194AAO

  • Instituto centenario

    Buenos Aires, C1204AAD

  • Fundación CIDEA

    Buenos Aires, C1425DTG

  • Atencion Integral En Reumatologia Buenos Aires

    Buenos Aires, C1426AAL

  • CEMIC

    Buenos Aires, C1431FWO

  • Hospital General de Agudos Dr. J. M. Ramos Mejia

    Ciudad Autonoma Buenos Aires, C1221ADC

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

  • Instituto Reumatológico Strusberg

    Córdoba, 5000

  • Hospital Italiano de Cordoba

    Córdoba, X5004BAL

  • Hospital Privado Cordoba

    Cordoba Pcia, 5016

  • Hospital Municipal Nuestra Sra. de Lujan

    Luján, 6700

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Sanatorio Parque de Rosario

    Rosario, S2000DSV

  • Instituto Centralizado de Asistencia e Investigaci

    Rosario, Santa Fe, S2000PBJ

  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, 5400

  • Centro de Investigaciones Médicas - CIM

    San Juan Bautista, 1888

  • Centro de Investigaciones Reumatologicas Tucuman

    San Miguel de Tucumán, 4000

  • Centro Médico Privado de Reumatología

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Canada17 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Arthur Karasik, MD

    Etobicoke, Ontario, M9C 5N2

  • Charlton Medical Center

    Hamilton, Ontario, L8N 1Y2

  • K-W Musculoskeletal Research

    Kitchener, Ontario, N2M 5N6

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • Credit Valley, Rheumatology

    Mississauga, Ontario, L5M 2V8

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec, H2L 1S6

  • The Medical Arts Health Research Group

    Powell River, British Columbia, V8A 3B6

  • Groupe de Recherche En Rhumatologie Et Maladies Osseuses

    Québec, Quebec, G1V 3M7

  • Centre Re Recherche Saint-Louis

    Québec, G1W 4R4

  • Chus Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Niagara Peninsula Arthritis Centre

    St. Catharines, Ontario, L2N 7E4

  • Nexus Clinical Research Centre

    St. John's, Newfoundland and Labrador, A1A 5E8

  • St. Clare'S Mercy Hospital

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1Z5

  • Centre de Recherche Musculo-Squelettique

    Trois-Rivières, Quebec, G8Z 1Y2

  • Baker, Milton F.

    Victoria, British Columbia, V8P 5P6

Other trials in Canada

Russia17 sites

  • State institution of health care - Territorial Clinical Hospital

    Barnaul, 656024

  • SEI of HPE "Altay State Medical University of Roszdrav"

    Barnaul, 656038

  • Scientific and research medical complex Your Health

    Kazan', 420097

  • SIH Kemerovo Regional Clinical Hospital

    Kemerovo, 650002

  • City Hospital No.4

    Moscow, 115093

  • Scient Res Inst Rheumat RAMS

    Moscow, 115522

  • Moscow State Medical Stomatological University

    Moscow, 121374

  • Head Clinical Hospital of Internal Affair Ministry of Russia

    Moscow, 123060

  • MHI City Clinical Hospital#19

    Novosibirsk, 630068

  • FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS

    Novosibirsk, 630099

  • Ryazan Regional Clinincal Cardiology Dispensary

    Ryazan, 390026

  • Leningradskaya Regional Clinical Hospital; Rheumatology Dept

    Saint Petersburg, 194291

  • State institution of healthcare "Regional hospital for war veterans"

    Saratov, 410002

  • Stavropol State Medical Academy

    Stavropol, 355017

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

  • Voronezh Regional Clinical Hospital #1

    Voronezh, 394066

  • MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant

    Yaroslavl, 150007

Other trials in Russia

France16 sites

  • CHU d'Amiens Hôpital Nord; Pharmacie Clinique

    Amiens, 80054

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33000

  • CHU Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

  • CHU Grenoble Sud

    Échirolles, 38434

  • Hôpital Edouard Herriot; Service de Rhumatologie

    Lyon, 69003

  • CHR Orleans, Hopital Madeleine

    Orléans, 45067

  • Hôpital Saint-Antoine; Service de Psychiatrie

    Paris, 75571

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651

  • Hopital Cochin; Gastro Enterologie

    Paris, 75679

  • Hôpital Sud - CHU de Rennes

    Rennes, 35033

  • Hôpital Victor Provo

    Roubaix, 59056

  • CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie

    Rouen, 76031

  • CHU Saint-Etienne, Hopital Bellevue

    Saint-Etienne, 42055

  • Hôpital General - CHRU de Dijon

    Strasbourg, 67098

  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

    Toulouse, 31059

Other trials in France

Germany16 sites

  • Charité Universitaetsmedizin Berlin, Campus Charité Mitte

    Berlin, 10117

  • Schlosspark-Klinik

    Berlin, 14059

  • Universitätsklinikum Köln, Klinik I für Innere Medizin

    Cologne, 50937

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • Universitätsklinikum Erlangen; Augenklinik

    Erlangen, 91054

  • Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN

    Erlangen, 91056

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60528

  • Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie

    Hamburg, 20251

  • Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

    Hamburg, 22081

  • Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus

    Herne, 44649

  • Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

    Hildesheim, 31134

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Ludwig Maximilians; Universitaet

    München, 80337

  • Praxiszentrum St. Bonifatius

    München, 81541

  • Rheumatologische Gemeinschaftspraxis

    Osnabrück, 49074

  • Evangelisches Fachkrankenhaus

    Ratingen, 40882

Other trials in Germany

Romania13 sites

  • Spitalul Clinic Judetean de Urgenta Brasov

    Brasov, 500365

  • Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie

    Bucharest, 011172

  • Spitalul Clinic Dr. I Cantacuzino

    Bucharest, 020475

  • Centrul de Boli Reumatismale Dr. Ioan Stoia

    Bucharest, 020983

  • Medex SRL

    Cluj-Napoca, 400130

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii

    Cluj-Napoca, 400349

  • CMI Dr.Ciornohuz Adriana

    Iași, 700127

  • Spitalul Clinic de Recuperare Iasi

    Iași, 700656

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

  • Spitalul Clinic Colentina

    Sector 2, 020125

  • Spitalul Judetean de Urgenta Targoviste

    Targoviste, 130083

  • Mediab SRL

    Târgu Mureş, 540142

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300194

Other trials in Romania

United Kingdom13 sites

  • Selly Oak Hospital; Rheumatology Dept

    Birmingham, B29 6JD

  • Addenbrooke's NHS Trust

    Cambridge, CB2 0QQ

  • Cannock Chase Hospital; Rheumatology

    Cannock, WS11 5XY

  • Russells Hall Hospital; Rheumatology Department

    Dudley, DY1 2HQ

  • Leicester Royal Infirmary NHS Trust

    Leicester, LE1 5WW

  • Royal London Hospital Outpatients Department

    London, E1 1BB

  • Whipps Cross Hospital; Rheumatology Dept

    London, E11 1NR

  • King'S College Hospital

    London, SE5 9RS

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD

  • Southampton General Hospital; Rheumatology

    Southampton, SO16 6YD

  • Southend Hospital; Rheumatology Department

    Westcliffe-on-sea, SS0 0RY

  • Wrightington Hospital

    Wrightington, WN6 9EP

Other trials in United Kingdom

Czechia12 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Revmatologicka ambulance

    Bruntál, 792 01

  • Revmatologicka Ambulance

    Hlučín, 748 01

  • Interni a revmatologicka ordinace

    Hostivice, 253 01

  • Revmatologicka a-interni ambulance

    Kladno, 272 01

  • Revmatologie MUDr. Klara Sirova s.r.o.

    Ostrava - Moravska Ostrava, 702 00

  • Revmatologicky Ustav

    Prague, 128 50

  • Revmatologicka ambulance

    Prague, 140 00

  • Fakultni Thomayerova nemocnice s poliklinikou

    Prague, 140 59

  • Artroscan s.r.o.

    Sokolov, 356 01

  • Revmatologicka Ambulance-Terezin

    Terezín, 411 55

  • PV - Medical, s.r.o.

    Zlín, 748 01

Other trials in Czechia

Spain12 sites

  • Hospital de Cruces; Servicio de Reumatologia

    Barakaldo, Vizcaya, 48903

  • Hospital Universitario Basurto

    Bilbao, Vizcaya, 48013

  • Hospital General de Castellon; Servicio de Reumatologia

    Castellon, Castellon, 12004

  • Hospital Gregorio Marañon

    Madrid, 28007

  • Hospital Regional Universitario Carlos Haya

    Málaga, Malaga, 29009

  • Hospital de Merida ;Servicio de Reumatologia

    Mérida, Badajoz, 06800

  • Hospital Universitario de Canarias

    S. Cristobal de La Laguna, Tenerife, 38320

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Infanta Sofia; Servicio de Reumatologia

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

  • Hospital Sierrallana

    Torrelavega, Cantabria, 39300

Other trials in Spain

Hungary11 sites

  • Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály

    Budapest, 1027

  • Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Synexus Magyarorszag Kft

    Budapest, 1036

  • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

    Debrecen, 4032

  • Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.

    Eger, 3300

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

    Gyula, 5700

  • Varosi Korhaz-Rendelointezet

    Mór, 8060

  • Fejer Megyei Szent Gyorgy Korhaz

    Székesfehérvár, 8000

  • Clinfan Szolgaltato Kft.

    Szekszárd, 7100

  • Zala Megyei Korhaz; Reumatologia

    Zalaegerszeg, 8901

Other trials in Hungary

Italy11 sites

  • Ospedale La Colletta

    Arenzano, Liguria, 16011

  • Ospedali Riuniti di Bergamo

    Bergamo, Lombardy, 24128

  • Presidio Ospedaliero Vittorio Emanuele

    Catania, Sicily, 95124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50141

  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria, 16132

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • Azienda Ospedaliera A. Cardarelli

    Naples, Campania, 80131

  • Ospedale San Giovanni Bosco; Divisione di Reumatologia

    Naples, Campania, 80144

  • Ospedale Misericordia e Dolce

    Prato, Tuscany, 59100

  • Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese

    Telese Terme, Campania, 82037

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, Lombardy, 21100

Other trials in Italy

Poland11 sites

  • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

    Bydgoszcz, 85-168

  • Wojewodzki Szpital Zespolony w Elblagu

    Elblag, 82-300

  • Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii

    Krakow, 30-119

  • Szpital Specjalistyczny im. J. Dietla

    Krakow, 31-121

  • NZOZ REUMED Sp. z o.o.

    Lublin, 20-607

  • Lecznica MAK-MED NZOZ

    Nadarzyn, 05-830

  • SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

    Szczecin, 71-252

  • Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny

    Ustroń, 43-450

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02-118

  • ARS Rheumatica Sp.z o. o

    Warsaw, 02-653

  • Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego

    Wroclaw, 50-556

Other trials in Poland

Chile9 sites

  • Hospital San Juan de Dios La Serena

    La Serena, 1700000

  • Centro Medico Prosalud

    Santiago, 7500000

  • Interin

    Santiago, 7500035

  • Centro de Estudios Reumatológicos

    Santiago, 7501126

  • Hospital Clinico Pontificia Universidad Catolica de Chile

    Santiago, 8320112

  • Centro de Investigacion Clinica del Sur

    Temuco, 4780000

  • Clinica Alemana de Temuco

    Temuco, 4780000

  • Hospital Clinico Viña del Mar- Oncovida

    Viña del Mar, 2520612

  • Centro de Estudios Clinicos V Region Limitada

    Viña del Mar

Other trials in Chile

Greece7 sites

  • Laiko General Hospital Athen

    Athens, 115 27

  • Euroclinic of Athens; Internal Medicine & Immunology Dept.

    Athens, 15121

  • University General Hospital of Heraklion

    Crete, 71110

  • University General Hospital of Larissa; Rheumatology Unit

    Larissa, 411 10

  • General Hospital of Thessaloniki Hippokration

    Thessaloniki, 54 642

  • Euromedica Kyanous Stavros General Hospital

    Thessaloniki, 546 36

  • 424 Military Training Hospital-Egnatia

    Thessaloniki

Other trials in Greece

India7 sites

  • Shalby Hospital Limited

    Ahmedabad, Gujarat, 380015

  • Vedanta Institute; Medical Sciences

    Ahmedabad, 380009

  • Manipal Hospital

    Bangalore, 560017

  • St.John's Medical College Hospital

    Banglore, 560034

  • Arthritis Super Speciality Centre

    Hubli, 580020

  • Care Institute of Medical Sciences

    Hyderabad, 500034

  • Jasleen Hospital

    Nagpur, 440010

Other trials in India

Latvia7 sites

  • L.Krumina GP practice

    Bauska, 3901

  • Daugavpils Regional Hospital

    Daugavpils, 5417

  • D.Saulite-Kandevica Private Practice

    Liepāja, 3400

  • Clinic ORTO

    Riga, 1005

  • Private Practice EHOKG

    Riga, 1021

  • Riga East Clinical University Hospital; Clinic Gailezers

    Riga, LV 1002

  • P. Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Ecuador6 sites

  • Hospital Clínica Santa Inés

    Cuenca, 101168

  • Centro de Reumatología y Rehabilitación

    Guayaquil, 593

  • OMNI Hospital

    Guayaquil, 593

  • Centro Medico Alcivar 4

    Guayaquil, EC090114

  • Centro Medico Picasso

    Quito, 005932

  • Novaclinica Santa Cecilia; Reumatology

    Quito, EC170517

Other trials in Ecuador

Malaysia6 sites

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30990

  • Hospital Selayang

    Kuala Lumpur, 68100

  • Sunway Medical Centre

    Kuala Selangor, Selangor, 46150

  • Sime Darby Medical Centre

    Kuala Selangor, Selangor, 47500

  • Hospital Umum Sarawak

    Kuching, 93586

Other trials in Malaysia

Austria5 sites

  • Lkh-Univ. Klinikum Graz

    Graz, 8036

  • Landesklinikum Weinviertel Stockerau; Rheumatologie

    Stockerau, 2000

  • Medizinische Universität Wien

    Vienna, 1090

  • Rheuma-Zentrum Favoriten Wien

    Vienna, 1100

  • Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A

    Vienna, 1130

Other trials in Austria

Belgium5 sites

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • AZ Groeninge (Vercruysselaan)

    Kortrijk, 8500

  • CHU Sart-Tilman

    Liège, 4000

  • ZNA Jan Palfijn

    Merksem, 2170

Other trials in Belgium

Croatia5 sites

  • General Hospital Karlovac

    Karlovac, 47000

  • Special Hospital for Medical Rehabilitation

    Krapinske Toplice, 49217

  • Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology

    Rijeka, 51000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Universtiy Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Israel5 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Assaf Harofeh Medical Center

    Beer Yaacov, 6093000

  • The Lady Davis Carmel Medical Center

    Haifa, 34362

  • Chaim Sheba Medical Center; Rheumatology

    Ramat Gan, 5262000

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Lithuania5 sites

  • Alytus Regional S. Kudirkos Hospital, Public Institution

    Alytus, 62114

  • Klaipeda Seamen's Hospital, Public Institution

    Klaipėda, 92288

  • Klaipeda University Hospital; Public Institution

    Klaipėda, 92288

  • Siauliai Republican Hospital Public Institution

    Šiauliai, 76231

  • Vilnius District Central Outpatient Clinic, Public Institution

    Vilnius, 06122

Other trials in Lithuania

Philippines5 sites

  • Cebu Doctors' University Hospital- North General Hospital

    Cebu City, 6000

  • Chong Hua Hospital, Cebu City

    Cebu City, 6000

  • St. Paul Hospital; Arthritis Center

    Iloilo City, 5000

  • Mary Mediatrix Medical Center

    Lipa City, 4217

  • Makati Medical Center

    Makati City, 1229

Other trials in Philippines

Bosnia and Herzegovina4 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000

  • University Clinic Ctr Sarajevo

    Sarajevo, 71 000

  • General Hospital Prim.dr.Abdulah Nakas

    Sarajevo, 71000

  • Uni Hospital Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Netherlands4 sites

  • Jan Van Breemen Instituut

    Amsterdam, 1056 AB

  • Albert Schweitzer Ziekenhuis ; Dordwijk

    Dordrecht, 3318AT

  • Franciscus Ziekenhuis

    Roosendaal, 4708 AE

  • Vlietland Hospital

    Schiedam, 3118 JH

Other trials in Netherlands

Serbia4 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • Clinical Center Bezanijska Kosa

    Belgrade, 11070

  • Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

    Niška Banja, 18205

Other trials in Serbia

South Africa4 sites

  • Groote Schuur Hospital; Rheumatology Unit

    Cape Town, 7925

  • Chris Hani Baragwanath Hospital; Rheumatology Department

    Diepkloof, 1862

  • Charlotte Maxeke Academic Hospital

    Johannesburg, 2193

  • University of Pretoria; Clinical Trial Unit

    Pretoria, 0002

Other trials in South Africa

Turkey (Türkiye)4 sites

  • Akdeniz Univesity Medical Faculty

    Antalya, 07058

  • Trakya University Medical Faculty

    Edirne, 22030

  • Ataturk University Med Faculty

    Erzurum, 25050

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61100

Other trials in Turkey (Türkiye)

About this study

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)

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).

Being tested
Etanercept, Tocilizumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptDrug

    Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

  • TocilizumabDrug

    Also called Actemra

    Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Study groups in NCT01331837
Study groupRoleWhat they receive
EtanerceptActive comparatorNot described
Receives: Drug: Etanercept
TocilizumabExperimentalNot described
Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline up to 4.9 years

  2. 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

    Measured: From baseline up to 4.9 years

  3. 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

    Measured: From Baseline up to 4.9 years

  4. 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

    Measured: From Baseline up to 4.9 years

  5. 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

    Measured: From baseline up to 4.9 years

  6. 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

    Measured: From baseline up to 4.9 years

  7. 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).

    Measured: From Baseline up to 4.9 years

  8. 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).

    Measured: From Baseline up to 4.9 years

Secondary outcomes (10)

  1. 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.

    Measured: From baseline up to 4.9 years

  2. 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.

    Measured: From baseline up to 4.9 years

  3. 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

    Measured: From baseline up to 4.9 years

  4. 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

    Measured: From baseline up to 4.9 years

  5. 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

    Measured: From baseline up to 4.9 years

  6. Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death

    Percentage of patients reporting Individual component of primary endpoint: cardiovascular death

    Measured: From baseline up to 4.9 years

  7. 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

    Measured: From baseline up to 4.9 years

  8. Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke

    Measured: From baseline up to 4.9 years

  9. 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

    Measured: From baseline up to 4.9 years

  10. Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality

    Percentage of patients reporting Individual component of primary endpoint: All-cause mortality

    Measured: From baseline up to 4.9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2011 (estimated)
  2. Study start2 Aug 2011
  3. Primary completion25 Mar 2016
  4. Study completion25 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,080 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01331837
Sponsor's protocol ID
WA25204
Other IDs
2010-020065-24
Status last verified
Jun 2017
First submitted
7 Apr 2011
Last updated
13 Jul 2017

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.

    PubMed 31469238

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etanercept and Tocilizumab in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 428 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 428 sites in United States, Mexico, Argentina, Canada, Russia and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event (time frame: From baseline up to 4.9 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01331837, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in