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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01331837

Public ClinicalTrials.gov record NCT01331837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 6:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01331837
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
3,080 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2, 2011 (Actual)
Primary completion
Mar 25, 2016 (Actual)
Completion
Mar 25, 2016 (Actual)
Last update posted
Jul 13, 2017

2011 – 2016

United States locations

U.S. sites
143
U.S. states
38
U.S. cities
128
Facility City State ZIP Site status
Uni Of Alabama,Birmingham; Medicine - Rheumatology Birmingham Alabama 35294 —
Rheumatology Associates of North Alabama Huntsville Alabama 35801 —
Clinical and Translational Research Center of Alabama, PC Tuscaloosa Alabama 35406 —
Arizona Arthritis & Rheumatology Associates, P.C. Glendale Arizona 85306 —
Arizona Arthritis & Rheumatology Research, Pllc Paradise Valley Arizona 85253 —
Sun Valley Arthritis Center Peoria Arizona 85381 —
Valley Arthritis Care Phoenix Arizona 85027 —
Advanced Arthritis Care & Research Scottsdale Arizona 85258 —
Camp Lowell Medical Specialists Tucson Arizona 85715 —
The University of Arizona Tucson Arizona 85724 —
NEA Baptist Clinic Jonesboro Arkansas 72401 —
OrthoArkansas; Orthopedics & Sports Medicine Little Rock Arkansas 72205 —
Samy Metyas, MD, Inc Covina California 91723 —
Talbert Medical Group Huntington Beach California 92646 —
Allergy & Rheumatology Medical Clinic, Inc La Jolla California 92037 —
Valerius Medical Group Los Alamitos California 90720 —
Clinical Interventions Research Institute Mission Viejo California 92692 —
Dr. Brigid Freyne, MD Murrieta California 92563 —
Sharp Rees-Stealy Medical Group Poway California 92064 —
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 —
Pacific Arthritis Ctr Med Grp Santa Maria California 93454 —
Orrin M. Troum, Md Santa Monica California 90404 —
Harbor UCLA Medical Center Torrance California 90509 —
Inland Rheumatology; Clinical Trials, Inc. Upland California 91786 —
Medvin Clinical Research Whittier California 90606 —
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs Colorado Springs Colorado 80920 —
Joao Nascimento Bridgeport Connecticut 06606 —
University of Connecticut Health Center Farmington Connecticut 06030 —
Arthritis & Osteoporosis Center Pc Hamden Connecticut 06518 —
ZASA Clinical Research Boynton Beach Florida 33472 —
DC Health Clinic Coral Gables Florida 33134 —
Tsai, Yong Daytona Beach Florida 32117 —
Jacksonville Center For Clinical Research Jacksonville Florida 32216 —
Pharmax Research Clinic Inc. Miami Florida 33126 —
Arthritis/Osteoporosis Treatment Center Orange Park Florida 32073 —
Arthritis Rsrch of Florida, Inc. Palm Harbor Florida 34684 —
Baptist Hospital Clinical Research Pensacola Florida 32501 —
Lovelace Scientific Resources Sarasota Florida 34292 —
Centre for Arthritis and Rheumatic Diseases South Miami Florida 33143 —
Pinellas Medical Research, LLC St. Petersburg Florida 33708 —
SW Florida Clinical Research Tampa Florida 33609 —
Healthpoint Medical group, Inc Tampa Florida 33614 —
Emory Uni ; Division of Rheumatology Atlanta Georgia 30303 —
Arthritis & Rheumatology of Georgia Atlanta Georgia 30342 —
North Georgia Rheumatology Duluth Georgia 30096 —
Harbin Clinic Rome Georgia 30165 —
St. Joseph'S/Candler Health System, Inc.; Office of Research Savannah Georgia 31405 —
Sonora Clinical Research Boise Idaho 83702 —
St. Luke's Intermountain Research Center Boise Idaho 83702 —
Selah Medical Ctr Boise Idaho 83704 —
Coeur D'Alene Arthritis Clinic Coeur d'Alene Idaho 83814 —
Idaho Arthritis Center Meridian Idaho 83642 —
University of Illinois at Chicago Chicago Illinois 60612 —
Apex Medical Research, AMR, Inc. Chicago Illinois 60616 —
Methodist Medical Center of Ilinois Peoria Illinois 61602 —
Northern Indiana Research Alliance Fort Wayne Indiana 46804 —
Diagnostic Rheumatology & Research Indianapolis Indiana 46227 —
Memorial Medical Group Clinical Research South Bend Indiana 46601 —
Graves Gilbert Clinic Bowling Green Kentucky 42101 —
Research Integrity Owensboro Kentucky 42303 —
Arthritis & Diabetes Clinic, Inc Monroe Louisiana 71203 —
Ochsner Health System New Orleans Louisiana 70121 —
Rheumatology Associates of Baltimore Baltimore Maryland 21286 —
Osteoporosis & Clinical Trials Center Hagerstown Maryland 21740 —
Center For Rheumatology & Bone Research Wheaton Maryland 20902 —
Phase Iii Clinical Research Fall River Massachusetts 02720 —
UMass Memorial Medical Center Worcester Massachusetts 01605 —
Clinical Pharmacology Study Group Worcester Massachusetts 01610 —
Hurley Research Center Flint Michigan 48503 —
Rheumatology, P.C.; Medical Arts Building Kalamazoo Michigan 49009 —
Advanced Rheumatology, PC Lansing Michigan 48910 —
Northern Michigan Regional Hospital Petoskey Michigan 49770 —
St. Paul Rheumatology Eagan Minnesota 55121 —
Va Medical Center Minneapolis Minnesota 55417 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
Jackson Arthritis Clinic Flowood Mississippi 39232 —
North Mississippi Med Clinics, Inc. Tupelo Mississippi 38801 —
Glacier View Research Institute Kalispell Montana 59901 —
Univ of Nebraska Medical Ctr Omaha Nebraska 68198 —
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 —
Nashua Rheumatology - Foundation Medical Partners Nashua New Hampshire 03060 —
Summit Medical Group Berkeley Heights New Jersey 07922 —
Rheumatology Associates Of New Jersey Teaneck New Jersey 07666 —
Arthritis Rheumatic & Back Disease Associates Voorhees Township New Jersey 08043 —
Albuquerque Center For Rheumatology Albuquerque New Mexico 87102 —
Arthritis and Osteoporosis Associates of New Mexico Las Cruces New Mexico 88011 —
Arthritis & Osteoporosis Medical Associates, Pllc Brooklyn New York 11201 —
SUNY Downstate Medical Center. Brooklyn New York 11203 —
DiGiovanna Inst for Med Ed&Res North Massapequa New York 11758 —
Southern Tier Arthritis & Rheumatism Olean New York 14760 —
Arthritis Health Associates; Clinical Research Syracuse New York 13210 —
Asheville Arthritis & Osteoporosis Center, PA Asheville North Carolina 28803 —
Joint & Muscle Research Institute Charlotte North Carolina 28204 —
Carolina Bone & Joint P.A. Charlotte North Carolina 28210 —
Durham Rheumatology Durham North Carolina 27704 —
PMG Research of Hickory LLC Hickory North Carolina 28602 —
Shanahan Rheumatology & Immunology, PLLC Raleigh North Carolina 27617 —
Specialty Medical Clinic and Research Center Sanford North Carolina 27330 —
Carolina Arthritis Associates, Pa Wilmington North Carolina 28401 —
Trinity Health Center Minot North Dakota 58701 —
Cincinnati Rheumatic Disease Study Group Cincinnati Ohio 45219 —
University Hospitals Case Medical Center Cleveland Ohio 44109 —
Ohio State Univ Med Center Columbus Ohio 43210 —
Columbus Arthritis Center Columbus Ohio 43215 —
Clinical Research Source, Inc. Toledo Ohio 43606 —
Toledo Clinic Toledo Ohio 43623 —
Lynn Health Science Institute Oklahoma City Oklahoma 73112 —
Altoona Center For Clinical Research Duncansville Pennsylvania 16635 —
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Ilumina Clinical Associates Indiana Pennsylvania 15701 —
PMA Medical Specialists Limerick Pennsylvania 19468 —
Pivotal Clinical Research, Llc Perkasie Pennsylvania 18944 —
Arthritis Group Philadelphia Pennsylvania 19152 —
University of Pittsburgh Medical Center Health System; Infectious Disease Pittsburgh Pennsylvania 15213-2582 —
Allegheny Rheumatology Wexford Pennsylvania 15090 —
Clinical Research Center of Reading Wyomissing Pennsylvania 19610 —
Pennsylvania Regional Center for Arthritis and Osteoporosis Research Wyomissing Pennsylvania 19610 —
Columbia Arthritis Center (Partnership Practice) Columbia South Carolina 29204 —
South Carolina Research Center Myrtle Beach South Carolina 29572 —
Brown Clinic Watertown South Dakota 57201 —
Ramesh Gupta - PP Memphis Tennessee 38119 —
Amarillo Center For Clinical Research Amarillo Texas 79124 —
Adriana Pop-Moody MD Clinic PA Corpus Christi Texas 78404 —
Metroplex Clinical Research Dallas Texas 75231 —
Leading Edge Research, PA; Office of Dr. Burbano Fort Worth Texas 76109 —
Rheumatic Disease Clin Res Ctr Houston Texas 77004 —
Houston Inst. For Clinical Research Houston Texas 77074 —
Southwest Rheumatology Mesquite Texas 75150 —
Leading Edge Research, PA; Office of Dr. Burbano Richardson Texas 75080 —
Texas Arthritis Research Center San Antonio Texas 78217 —
Arthritis & Osteoporosis Clinic Waco Texas 76710 —
Arthritis and Rheumatic Disease Associates Burke Virginia 22015 —
Sentara Medical Group Norfolk Virginia 23510 —
Apex Clinical Research Kennewick Washington 99336 —
Seattle Rheumatology Associates Seattle Washington 98104 —
Office of George Krick, Md Tacoma Washington 98405 —
Rheum & Pulmonary Clinic Beckley West Virginia 25801 —
Mountain State Clinical Research Clarksburg West Virginia 26301 —
Arthritis Centre; Suite 103 Racine Wisconsin 53406 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 285 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01331837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 13, 2017 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01331837 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →