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

NCT ID: NCT01331837

Last Updated: 2017-07-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-02

Study Completion Date

2016-03-25

Brief Summary

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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).

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

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

Tocilizumab

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

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

Interventions

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Etanercept

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

Intervention Type DRUG

Tocilizumab

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

Intervention Type DRUG

Other Intervention Names

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Actemra

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, , Germany

Site Status

Universitätsklinikum Erlangen; Augenklinik

Erlangen, , Germany

Site Status

Uni Of Alabama,Birmingham; Medicine - Rheumatology

Birmingham, Alabama, United States

Site Status

Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Clinical and Translational Research Center of Alabama, PC

Tuscaloosa, Alabama, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Research, Pllc

Paradise Valley, Arizona, United States

Site Status

Sun Valley Arthritis Center

Peoria, Arizona, United States

Site Status

Valley Arthritis Care

Phoenix, Arizona, United States

Site Status

Advanced Arthritis Care & Research

Scottsdale, Arizona, United States

Site Status

Camp Lowell Medical Specialists

Tucson, Arizona, United States

Site Status

The University of Arizona

Tucson, Arizona, United States

Site Status

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Site Status

OrthoArkansas; Orthopedics & Sports Medicine

Little Rock, Arkansas, United States

Site Status

Samy Metyas, MD, Inc

Covina, California, United States

Site Status

Talbert Medical Group

Huntington Beach, California, United States

Site Status

Allergy & Rheumatology Medical Clinic, Inc

La Jolla, California, United States

Site Status

Valerius Medical Group

Los Alamitos, California, United States

Site Status

Clinical Interventions Research Institute

Mission Viejo, California, United States

Site Status

Dr. Brigid Freyne, MD

Murrieta, California, United States

Site Status

Sharp Rees-Stealy Medical Group

Poway, California, United States

Site Status

San Diego Arthritis Med Clnc

San Diego, California, United States

Site Status

Purushotham & Akther Kotha Inc

San Diego, California, United States

Site Status

C Michael Neuwelt MD Inc

San Leandro, California, United States

Site Status

Pacific Arthritis Ctr Med Grp

Santa Maria, California, United States

Site Status

Orrin M. Troum, Md

Santa Monica, California, United States

Site Status

Harbor UCLA Medical Center

Torrance, California, United States

Site Status

Inland Rheumatology; Clinical Trials, Inc.

Upland, California, United States

Site Status

Medvin Clinical Research

Whittier, California, United States

Site Status

Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Joao Nascimento

Bridgeport, Connecticut, United States

Site Status

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Arthritis & Osteoporosis Center Pc

Hamden, Connecticut, United States

Site Status

ZASA Clinical Research

Boynton Beach, Florida, United States

Site Status

DC Health Clinic

Coral Gables, Florida, United States

Site Status

Tsai, Yong

Daytona Beach, Florida, United States

Site Status

Jacksonville Center For Clinical Research

Jacksonville, Florida, United States

Site Status

Pharmax Research Clinic Inc.

Miami, Florida, United States

Site Status

Arthritis/Osteoporosis Treatment Center

Orange Park, Florida, United States

Site Status

Arthritis Rsrch of Florida, Inc.

Palm Harbor, Florida, United States

Site Status

Baptist Hospital Clinical Research

Pensacola, Florida, United States

Site Status

Lovelace Scientific Resources

Sarasota, Florida, United States

Site Status

Centre for Arthritis and Rheumatic Diseases

South Miami, Florida, United States

Site Status

Pinellas Medical Research, LLC

St. Petersburg, Florida, United States

Site Status

SW Florida Clinical Research

Tampa, Florida, United States

Site Status

Healthpoint Medical group, Inc

Tampa, Florida, United States

Site Status

Emory Uni ; Division of Rheumatology

Atlanta, Georgia, United States

Site Status

Arthritis & Rheumatology of Georgia

Atlanta, Georgia, United States

Site Status

North Georgia Rheumatology

Duluth, Georgia, United States

Site Status

Harbin Clinic

Rome, Georgia, United States

Site Status

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

Savannah, Georgia, United States

Site Status

Sonora Clinical Research

Boise, Idaho, United States

Site Status

St. Luke's Intermountain Research Center

Boise, Idaho, United States

Site Status

Selah Medical Ctr

Boise, Idaho, United States

Site Status

Coeur D'Alene Arthritis Clinic

Coeur d'Alene, Idaho, United States

Site Status

Idaho Arthritis Center

Meridian, Idaho, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Apex Medical Research, AMR, Inc.

Chicago, Illinois, United States

Site Status

Methodist Medical Center of Ilinois

Peoria, Illinois, United States

Site Status

Northern Indiana Research Alliance

Fort Wayne, Indiana, United States

Site Status

Diagnostic Rheumatology & Research

Indianapolis, Indiana, United States

Site Status

Memorial Medical Group Clinical Research

South Bend, Indiana, United States

Site Status

Graves Gilbert Clinic

Bowling Green, Kentucky, United States

Site Status

Research Integrity

Owensboro, Kentucky, United States

Site Status

Arthritis & Diabetes Clinic, Inc

Monroe, Louisiana, United States

Site Status

Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Rheumatology Associates of Baltimore

Baltimore, Maryland, United States

Site Status

Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, United States

Site Status

Center For Rheumatology & Bone Research

Wheaton, Maryland, United States

Site Status

Phase Iii Clinical Research

Fall River, Massachusetts, United States

Site Status

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Hurley Research Center

Flint, Michigan, United States

Site Status

Rheumatology, P.C.; Medical Arts Building

Kalamazoo, Michigan, United States

Site Status

Advanced Rheumatology, PC

Lansing, Michigan, United States

Site Status

Northern Michigan Regional Hospital

Petoskey, Michigan, United States

Site Status

St. Paul Rheumatology

Eagan, Minnesota, United States

Site Status

Va Medical Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Jackson Arthritis Clinic

Flowood, Mississippi, United States

Site Status

North Mississippi Med Clinics, Inc.

Tupelo, Mississippi, United States

Site Status

Glacier View Research Institute

Kalispell, Montana, United States

Site Status

Univ of Nebraska Medical Ctr

Omaha, Nebraska, United States

Site Status

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Site Status

Innovative Health Research

Las Vegas, Nevada, United States

Site Status

Dartmouth-Hitchcock Medical Center, Rheumatology 5C

Lebanon, New Hampshire, United States

Site Status

Nashua Rheumatology - Foundation Medical Partners

Nashua, New Hampshire, United States

Site Status

Summit Medical Group

Berkeley Heights, New Jersey, United States

Site Status

Rheumatology Associates Of New Jersey

Teaneck, New Jersey, United States

Site Status

Arthritis Rheumatic & Back Disease Associates

Voorhees Township, New Jersey, United States

Site Status

Albuquerque Center For Rheumatology

Albuquerque, New Mexico, United States

Site Status

Arthritis and Osteoporosis Associates of New Mexico

Las Cruces, New Mexico, United States

Site Status

Arthritis & Osteoporosis Medical Associates, Pllc

Brooklyn, New York, United States

Site Status

SUNY Downstate Medical Center.

Brooklyn, New York, United States

Site Status

DiGiovanna Inst for Med Ed&Res

North Massapequa, New York, United States

Site Status

Southern Tier Arthritis & Rheumatism

Olean, New York, United States

Site Status

Arthritis Health Associates; Clinical Research

Syracuse, New York, United States

Site Status

Asheville Arthritis & Osteoporosis Center, PA

Asheville, North Carolina, United States

Site Status

Joint & Muscle Research Institute

Charlotte, North Carolina, United States

Site Status

Carolina Bone & Joint P.A.

Charlotte, North Carolina, United States

Site Status

Durham Rheumatology

Durham, North Carolina, United States

Site Status

PMG Research of Hickory LLC

Hickory, North Carolina, United States

Site Status

Shanahan Rheumatology & Immunology, PLLC

Raleigh, North Carolina, United States

Site Status

Specialty Medical Clinic and Research Center

Sanford, North Carolina, United States

Site Status

Carolina Arthritis Associates, Pa

Wilmington, North Carolina, United States

Site Status

Trinity Health Center

Minot, North Dakota, United States

Site Status

Cincinnati Rheumatic Disease Study Group

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Ohio State Univ Med Center

Columbus, Ohio, United States

Site Status

Columbus Arthritis Center

Columbus, Ohio, United States

Site Status

Clinical Research Source, Inc.

Toledo, Ohio, United States

Site Status

Toledo Clinic

Toledo, Ohio, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Ilumina Clinical Associates

Indiana, Pennsylvania, United States

Site Status

PMA Medical Specialists

Limerick, Pennsylvania, United States

Site Status

Pivotal Clinical Research, Llc

Perkasie, Pennsylvania, United States

Site Status

Arthritis Group

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center Health System; Infectious Disease

Pittsburgh, Pennsylvania, United States

Site Status

Allegheny Rheumatology

Wexford, Pennsylvania, United States

Site Status

Clinical Research Center of Reading

Wyomissing, Pennsylvania, United States

Site Status

Pennsylvania Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, United States

Site Status

Columbia Arthritis Center (Partnership Practice)

Columbia, South Carolina, United States

Site Status

South Carolina Research Center

Myrtle Beach, South Carolina, United States

Site Status

Brown Clinic

Watertown, South Dakota, United States

Site Status

Ramesh Gupta - PP

Memphis, Tennessee, United States

Site Status

Amarillo Center For Clinical Research

Amarillo, Texas, United States

Site Status

Adriana Pop-Moody MD Clinic PA

Corpus Christi, Texas, United States

Site Status

Metroplex Clinical Research

Dallas, Texas, United States

Site Status

Leading Edge Research, PA; Office of Dr. Burbano

Fort Worth, Texas, United States

Site Status

Rheumatic Disease Clin Res Ctr

Houston, Texas, United States

Site Status

Houston Inst. For Clinical Research

Houston, Texas, United States

Site Status

Southwest Rheumatology

Mesquite, Texas, United States

Site Status

Leading Edge Research, PA; Office of Dr. Burbano

Richardson, Texas, United States

Site Status

Texas Arthritis Research Center

San Antonio, Texas, United States

Site Status

Arthritis & Osteoporosis Clinic

Waco, Texas, United States

Site Status

Arthritis and Rheumatic Disease Associates

Burke, Virginia, United States

Site Status

Sentara Medical Group

Norfolk, Virginia, United States

Site Status

Apex Clinical Research

Kennewick, Washington, United States

Site Status

Seattle Rheumatology Associates

Seattle, Washington, United States

Site Status

Office of George Krick, Md

Tacoma, Washington, United States

Site Status

Rheum & Pulmonary Clinic

Beckley, West Virginia, United States

Site Status

Mountain State Clinical Research

Clarksburg, West Virginia, United States

Site Status

Arthritis Centre; Suite 103

Racine, Wisconsin, United States

Site Status

Centro de Investigaciones Reumatologicas y Osteologicas

Buenos Aires, , Argentina

Site Status

Organizacion Medica de Investigacion

Buenos Aires, , Argentina

Site Status

CEIM Consultorios Especializados en Investigaciones Médicas

Buenos Aires, , Argentina

Site Status

APRILLUS

Buenos Aires, , Argentina

Site Status

Instituto centenario

Buenos Aires, , Argentina

Site Status

Fundación CIDEA

Buenos Aires, , Argentina

Site Status

Atencion Integral En Reumatologia Buenos Aires

Buenos Aires, , Argentina

Site Status

CEMIC

Buenos Aires, , Argentina

Site Status

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

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Hospital Privado Cordoba

Cordoba Pcia, , Argentina

Site Status

Instituto Reumatológico Strusberg

Córdoba, , Argentina

Site Status

Hospital Italiano de Cordoba

Córdoba, , Argentina

Site Status

Hospital Municipal Nuestra Sra. de Lujan

Luján, , Argentina

Site Status

Centro de Investigacion Pergamino SA

Pergamino, , Argentina

Site Status

Sanatorio Parque de Rosario

Rosario, , Argentina

Site Status

Instituto Centralizado de Asistencia e Investigaci

Rosario, Santa Fe, , Argentina

Site Status

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, , Argentina

Site Status

Centro de Investigaciones Médicas - CIM

San Juan Bautista, , Argentina

Site Status

Centro de Investigaciones Reumatologicas Tucuman

San Miguel de Tucumán, , Argentina

Site Status

Centro Médico Privado de Reumatología

San Miguel de Tucumán, , Argentina

Site Status

Lkh-Univ. Klinikum Graz

Graz, , Austria

Site Status

Landesklinikum Weinviertel Stockerau; Rheumatologie

Stockerau, , Austria

Site Status

Medizinische Universität Wien

Vienna, , Austria

Site Status

Rheuma-Zentrum Favoriten Wien

Vienna, , Austria

Site Status

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

Vienna, , Austria

Site Status

CHU St Pierre (St Pierre)

Brussels, , Belgium

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

AZ Groeninge (Vercruysselaan)

Kortrijk, , Belgium

Site Status

CHU Sart-Tilman

Liège, , Belgium

Site Status

ZNA Jan Palfijn

Merksem, , Belgium

Site Status

University Clinical Center of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

Site Status

University Clinic Ctr Sarajevo

Sarajevo, , Bosnia and Herzegovina

Site Status

General Hospital Prim.dr.Abdulah Nakas

Sarajevo, , Bosnia and Herzegovina

Site Status

Uni Hospital Center Tuzla

Tuzla, , Bosnia and Herzegovina

Site Status

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

The Medical Arts Health Research Group

Powell River, British Columbia, Canada

Site Status

Baker, Milton F.

Victoria, British Columbia, Canada

Site Status

Nexus Clinical Research Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

St. Clare'S Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Site Status

Arthur Karasik, MD

Etobicoke, Ontario, Canada

Site Status

Charlton Medical Center

Hamilton, Ontario, Canada

Site Status

K-W Musculoskeletal Research

Kitchener, Ontario, Canada

Site Status

St. Joseph's Hospital

London, Ontario, Canada

Site Status

Credit Valley, Rheumatology

Mississauga, Ontario, Canada

Site Status

Niagara Peninsula Arthritis Centre

St. Catharines, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Institut de Rhumatologie de Montreal

Montreal, Quebec, Canada

Site Status

Groupe de Recherche En Rhumatologie Et Maladies Osseuses

Québec, Quebec, Canada

Site Status

Chus Hopital Fleurimont

Sherbrooke, Quebec, Canada

Site Status

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, Canada

Site Status

Centre Re Recherche Saint-Louis

Québec, , Canada

Site Status

Hospital San Juan de Dios La Serena

La Serena, , Chile

Site Status

Centro Medico Prosalud

Santiago, , Chile

Site Status

Interin

Santiago, , Chile

Site Status

Centro de Estudios Reumatológicos

Santiago, , Chile

Site Status

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status

Centro de Investigacion Clinica del Sur

Temuco, , Chile

Site Status

Clinica Alemana de Temuco

Temuco, , Chile

Site Status

Hospital Clinico Viña del Mar- Oncovida

Viña del Mar, , Chile

Site Status

Centro de Estudios Clinicos V Region Limitada

Viña del Mar, , Chile

Site Status

General Hospital Karlovac

Karlovac, , Croatia

Site Status

Special Hospital for Medical Rehabilitation

Krapinske Toplice, , Croatia

Site Status

Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology

Rijeka, , Croatia

Site Status

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Universtiy Hospital Dubrava

Zagreb, , Croatia

Site Status

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Site Status

Revmatologicka ambulance

Bruntál, , Czechia

Site Status

Revmatologicka Ambulance

Hlučín, , Czechia

Site Status

Interni a revmatologicka ordinace

Hostivice, , Czechia

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Revmatologicka a-interni ambulance

Kladno, , Czechia

Site Status

Revmatologie MUDr. Klara Sirova s.r.o.

Ostrava - Moravska Ostrava, , Czechia

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Revmatologicky Ustav

Prague, , Czechia

Site Status

Revmatologicka ambulance

Prague, , Czechia

Site Status

Fakultni Thomayerova nemocnice s poliklinikou

Prague, , Czechia

Site Status

Artroscan s.r.o.

Sokolov, , Czechia

Site Status

Revmatologicka Ambulance-Terezin

Terezín, , Czechia

Site Status

PV - Medical, s.r.o.

Zlín, , Czechia

Site Status

Hospital Clínica Santa Inés

Cuenca, , Ecuador

Site Status

Centro de Reumatología y Rehabilitación

Guayaquil, , Ecuador

Site Status

OMNI Hospital

Guayaquil, , Ecuador

Site Status

Centro Medico Alcivar 4

Guayaquil, , Ecuador

Site Status

Centro Medico Picasso

Quito, , Ecuador

Site Status

Novaclinica Santa Cecilia; Reumatology

Quito, , Ecuador

Site Status

CHU d'Amiens Hôpital Nord; Pharmacie Clinique

Amiens, , France

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Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

CHU Hopital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

CHU Grenoble Sud

Échirolles, , France

Site Status

Hôpital Edouard Herriot; Service de Rhumatologie

Lyon, , France

Site Status

CHR Orleans, Hopital Madeleine

Orléans, , France

Site Status

Hôpital Saint-Antoine; Service de Psychiatrie

Paris, , France

Site Status

Groupe Hospitalier Pitie-Salpetriere

Paris, , France

Site Status

Hopital Cochin; Gastro Enterologie

Paris, , France

Site Status

Hôpital Sud - CHU de Rennes

Rennes, , France

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Hôpital Victor Provo

Roubaix, , France

Site Status

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

Rouen, , France

Site Status

CHU Saint-Etienne, Hopital Bellevue

Saint-Etienne, , France

Site Status

Hôpital General - CHRU de Dijon

Strasbourg, , France

Site Status

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

Toulouse, , France

Site Status

Charité Universitaetsmedizin Berlin, Campus Charité Mitte

Berlin, , Germany

Site Status

Schlosspark-Klinik

Berlin, , Germany

Site Status

Universitätsklinikum Köln, Klinik I für Innere Medizin

Cologne, , Germany

Site Status

Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN

Erlangen, , Germany

Site Status

Universitaetsklinikum Frankfurt

Frankfurt, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie

Hamburg, , Germany

Site Status

Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

Hamburg, , Germany

Site Status

Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus

Herne, , Germany

Site Status

Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

Hildesheim, , Germany

Site Status

Universitaetsklinikum Leipzig

Leipzig, , Germany

Site Status

Ludwig Maximilians; Universitaet

München, , Germany

Site Status

Praxiszentrum St. Bonifatius

München, , Germany

Site Status

Rheumatologische Gemeinschaftspraxis

Osnabrück, , Germany

Site Status

Evangelisches Fachkrankenhaus

Ratingen, , Germany

Site Status

Laiko General Hospital Athen

Athens, , Greece

Site Status

Euroclinic of Athens; Internal Medicine & Immunology Dept.

Athens, , Greece

Site Status

University General Hospital of Heraklion

Crete, , Greece

Site Status

University General Hospital of Larissa; Rheumatology Unit

Larissa, , Greece

Site Status

General Hospital of Thessaloniki Hippokration

Thessaloniki, , Greece

Site Status

Euromedica Kyanous Stavros General Hospital

Thessaloniki, , Greece

Site Status

424 Military Training Hospital-Egnatia

Thessaloniki, , Greece

Site Status

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

Budapest, , Hungary

Site Status

Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft

Budapest, , Hungary

Site Status

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Site Status

Synexus Magyarorszag Kft

Budapest, , Hungary

Site Status

Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

Debrecen, , Hungary

Site Status

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

Eger, , Hungary

Site Status

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

Gyula, , Hungary

Site Status

Varosi Korhaz-Rendelointezet

Mór, , Hungary

Site Status

Clinfan Szolgaltato Kft.

Szekszárd, , Hungary

Site Status

Fejer Megyei Szent Gyorgy Korhaz

Székesfehérvár, , Hungary

Site Status

Zala Megyei Korhaz; Reumatologia

Zalaegerszeg, , Hungary

Site Status

Shalby Hospital Limited

Ahmedabad, Gujarat, India

Site Status

Vedanta Institute; Medical Sciences

Ahmedabad, , India

Site Status

Manipal Hospital

Bangalore, , India

Site Status

St.John's Medical College Hospital

Banglore, , India

Site Status

Arthritis Super Speciality Centre

Hubli, , India

Site Status

Care Institute of Medical Sciences

Hyderabad, , India

Site Status

Jasleen Hospital

Nagpur, , India

Site Status

Barzilai Medical Center

Ashkelon, , Israel

Site Status

Assaf Harofeh Medical Center

Beer Yaacov, , Israel

Site Status

The Lady Davis Carmel Medical Center

Haifa, , Israel

Site Status

Chaim Sheba Medical Center; Rheumatology

Ramat Gan, , Israel

Site Status

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Azienda Ospedaliera A. Cardarelli

Napoli, Campania, Italy

Site Status

Ospedale San Giovanni Bosco; Divisione di Reumatologia

Napoli, Campania, Italy

Site Status

Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese

Telese Terme, Campania, Italy

Site Status

Ospedale La Colletta

Arenzano, Liguria, Italy

Site Status

Azienda Ospedaliero Universitaria San Martino

Genoa, Liguria, Italy

Site Status

Ospedali Riuniti di Bergamo

Bergamo, Lombardy, Italy

Site Status

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, Italy

Site Status

Ospedale Di Circolo E Fondazione Macchi

Varese, Lombardy, Italy

Site Status

Presidio Ospedaliero Vittorio Emanuele

Catania, Sicily, Italy

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Site Status

Ospedale Misericordia e Dolce

Prato, Tuscany, Italy

Site Status

L.Krumina GP practice

Bauska, , Latvia

Site Status

Daugavpils Regional Hospital

Daugavpils, , Latvia

Site Status

D.Saulite-Kandevica Private Practice

Liepāja, , Latvia

Site Status

Clinic ORTO

Riga, , Latvia

Site Status

Private Practice EHOKG

Riga, , Latvia

Site Status

Riga East Clinical University Hospital; Clinic Gailezers

Riga, , Latvia

Site Status

P. Stradins Clinical University Hospital

Riga, , Latvia

Site Status

Alytus Regional S. Kudirkos Hospital, Public Institution

Alytus, , Lithuania

Site Status

Klaipeda Seamen's Hospital, Public Institution

Klaipėda, , Lithuania

Site Status

Klaipeda University Hospital; Public Institution

Klaipėda, , Lithuania

Site Status

Siauliai Republican Hospital Public Institution

Šiauliai, , Lithuania

Site Status

Vilnius District Central Outpatient Clinic, Public Institution

Vilnius, , Lithuania

Site Status

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Site Status

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Site Status

Sunway Medical Centre

Kuala Selangor, Selangor, Malaysia

Site Status

Sime Darby Medical Centre

Kuala Selangor, Selangor, Malaysia

Site Status

Hospital Selayang

Kuala Lumpur, , Malaysia

Site Status

Hospital Umum Sarawak

Kuching, , Malaysia

Site Status

Centro de Investigacion del Noroeste SC

Tijuana, Estado de Baja California, Mexico

Site Status

Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

Culiacán, Sinaloa, Mexico

Site Status

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

Mérida, Yucatán, Mexico

Site Status

Hospital Christus Muguerza del Parque; Reumatologia

Chihuahua City, , Mexico

Site Status

Hospital CIMA Chihuahua; Reumatologia

Chihuahua City, , Mexico

Site Status

Hospital Privado San Jose de Ciudad Obregon SA de CV

Ciudad Obregón, , Mexico

Site Status

Private Practice Dr. Cortes

Cuernavaca, , Mexico

Site Status

RM pharma specialist SA de CV

Delegacion Benito Juarez, , Mexico

Site Status

Mentrials S.A. de C.V

Distrito Federal, , Mexico

Site Status

Centro de Investigacion y Atencion Integral Durango CIAID

Durango, , Mexico

Site Status

Mundo Fisico

Guadalajara, , Mexico

Site Status

Clinica Hospital Angeles Chapalita

Guadalajara, , Mexico

Site Status

Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

Mexicali, , Mexico

Site Status

Inst. Mexicano de Investigacion Clinica

Mexico City, , Mexico

Site Status

Hospital Mocel

Mexico City, , Mexico

Site Status

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, , Mexico

Site Status

Mexico Centre for Clinical Research

México, , Mexico

Site Status

Comite Mexicano Para la Prevencion de Osteoporosis AC

México, , Mexico

Site Status

Cliditer SA de CV

Miexico City, , Mexico

Site Status

Hospital Universitario de Saltillo

Saltillo, , Mexico

Site Status

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosi S.l.p., , Mexico

Site Status

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

San Luis Potosí City, , Mexico

Site Status

Unidad de Enfermedades Reumaticas y Cronicodegenerativas

Torreón, , Mexico

Site Status

Jan Van Breemen Instituut

Amsterdam, , Netherlands

Site Status

Albert Schweitzer Ziekenhuis ; Dordwijk

Dordrecht, , Netherlands

Site Status

Franciscus Ziekenhuis

Roosendaal, , Netherlands

Site Status

Vlietland Hospital

Schiedam, , Netherlands

Site Status

Cebu Doctors' University Hospital- North General Hospital

Cebu City, , Philippines

Site Status

Chong Hua Hospital, Cebu City

Cebu City, , Philippines

Site Status

St. Paul Hospital; Arthritis Center

Iloilo City, , Philippines

Site Status

Mary Mediatrix Medical Center

Lipa City, , Philippines

Site Status

Makati Medical Center

Makati City, , Philippines

Site Status

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

Bydgoszcz, , Poland

Site Status

Wojewodzki Szpital Zespolony w Elblagu

Elblag, , Poland

Site Status

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

Krakow, , Poland

Site Status

Szpital Specjalistyczny im. J. Dietla

Krakow, , Poland

Site Status

NZOZ REUMED Sp. z o.o.

Lublin, , Poland

Site Status

Lecznica MAK-MED NZOZ

Nadarzyn, , Poland

Site Status

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

Szczecin, , Poland

Site Status

Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny

Ustroń, , Poland

Site Status

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, , Poland

Site Status

ARS Rheumatica Sp.z o. o

Warsaw, , Poland

Site Status

Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego

Wroclaw, , Poland

Site Status

Spitalul Clinic Judetean de Urgenta Brasov

Brasov, , Romania

Site Status

Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie

Bucharest, , Romania

Site Status

Spitalul Clinic Dr. I Cantacuzino

Bucharest, , Romania

Site Status

Centrul de Boli Reumatismale Dr. Ioan Stoia

Bucharest, , Romania

Site Status

Medex SRL

Cluj-Napoca, , Romania

Site Status

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

Cluj-Napoca, , Romania

Site Status

CMI Dr.Ciornohuz Adriana

Iași, , Romania

Site Status

Spitalul Clinic de Recuperare Iasi

Iași, , Romania

Site Status

Spitalul Municipal Ploiesti

Ploieşti, , Romania

Site Status

Spitalul Clinic Colentina

Sector 2, , Romania

Site Status

Spitalul Judetean de Urgenta Targoviste

Târgovişte, , Romania

Site Status

Mediab SRL

Târgu Mureş, , Romania

Site Status

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, , Romania

Site Status

State institution of health care - Territorial Clinical Hospital

Barnaul, , Russia

Site Status

SEI of HPE "Altay State Medical University of Roszdrav"

Barnaul, , Russia

Site Status

Scientific and research medical complex Your Health

Kazan', , Russia

Site Status

SIH Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

Site Status

City Hospital No.4

Moscow, , Russia

Site Status

Scient Res Inst Rheumat RAMS

Moscow, , Russia

Site Status

Moscow State Medical Stomatological University

Moscow, , Russia

Site Status

Head Clinical Hospital of Internal Affair Ministry of Russia

Moscow, , Russia

Site Status

MHI City Clinical Hospital#19

Novosibirsk, , Russia

Site Status

FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS

Novosibirsk, , Russia

Site Status

Ryazan Regional Clinincal Cardiology Dispensary

Ryazan, , Russia

Site Status

Leningradskaya Regional Clinical Hospital; Rheumatology Dept

Saint Petersburg, , Russia

Site Status

State institution of healthcare "Regional hospital for war veterans"

Saratov, , Russia

Site Status

Stavropol State Medical Academy

Stavropol, , Russia

Site Status

Tomsk Regional Clinical Hospital

Tomsk, , Russia

Site Status

Voronezh Regional Clinical Hospital #1

Voronezh, , Russia

Site Status

MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant

Yaroslavl, , Russia

Site Status

Institute of Rheumatology

Belgrade, , Serbia

Site Status

Military Medical Academy

Belgrade, , Serbia

Site Status

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

Site Status

Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

Niška Banja, , Serbia

Site Status

Groote Schuur Hospital; Rheumatology Unit

Cape Town, , South Africa

Site Status

Chris Hani Baragwanath Hospital; Rheumatology Department

Diepkloof, , South Africa

Site Status

Charlotte Maxeke Academic Hospital

Johannesburg, , South Africa

Site Status

University of Pretoria; Clinical Trial Unit

Pretoria, , South Africa

Site Status

Hospital de Merida ;Servicio de Reumatologia

Mérida, Badajoz, Spain

Site Status

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Hospital Sierrallana

Torrelavega, Cantabria, Spain

Site Status

Hospital General de Castellon; Servicio de Reumatologia

Castellon, Castellon, Spain

Site Status

Hospital Clinico Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Site Status

Hospital Infanta Sofia; Servicio de Reumatologia

San Sebastián de los Reyes, Madrid, Spain

Site Status

Hospital Regional Universitario Carlos Haya

Málaga, Malaga, Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status

Hospital Universitario de Canarias

S. Cristobal de La Laguna, Tenerife, Spain

Site Status

Hospital de Cruces; Servicio de Reumatologia

Barakaldo, Vizcaya, Spain

Site Status

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain

Site Status

Hospital Gregorio Marañon

Madrid, , Spain

Site Status

Akdeniz Univesity Medical Faculty

Antalya, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Ataturk University Med Faculty

Erzurum, , Turkey (Türkiye)

Site Status

Karadeniz Tecnical Uni. Med. Fac.

Trabzon, , Turkey (Türkiye)

Site Status

Selly Oak Hospital; Rheumatology Dept

Birmingham, , United Kingdom

Site Status

Addenbrooke's NHS Trust

Cambridge, , United Kingdom

Site Status

Cannock Chase Hospital; Rheumatology

Cannock, , United Kingdom

Site Status

Russells Hall Hospital; Rheumatology Department

Dudley, , United Kingdom

Site Status

Leicester Royal Infirmary NHS Trust

Leicester, , United Kingdom

Site Status

Royal London Hospital Outpatients Department

London, , United Kingdom

Site Status

Whipps Cross Hospital; Rheumatology Dept

London, , United Kingdom

Site Status

King'S College Hospital

London, , United Kingdom

Site Status

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status

Salford Royal NHS Foundation Trust

Salford, , United Kingdom

Site Status

Southampton General Hospital; Rheumatology

Southampton, , United Kingdom

Site Status

Southend Hospital; Rheumatology Department

Westcliffe-on-sea, , United Kingdom

Site Status

Wrightington Hospital

Wrightington, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Austria Belgium Bosnia and Herzegovina Canada Chile Croatia Czechia Ecuador France Germany Greece Hungary India Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Philippines Poland Romania Russia Serbia South Africa Spain Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31469238 (View on PubMed)

Other Identifiers

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2010-020065-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WA25204

Identifier Type: -

Identifier Source: org_study_id

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