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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT01331837
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etanercept — DRUG
    Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
  • Tocilizumab — DRUG
    Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Study Details

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).

Key Dates

Start date
Aug 2, 2011
Status verified
Jun 2017
Primary completion
Mar 25, 2016
Completion
Mar 25, 2016

Study Design

Enrollment
3,080 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Etanercept
  • Experimental: Tocilizumab

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 ]

Locations (143)

FacilityCityStateZIPSite coordinators
Uni Of Alabama,Birmingham; Medicine - RheumatologyBirminghamAlabama35294-
Rheumatology Associates of North AlabamaHuntsvilleAlabama35801-
Clinical and Translational Research Center of Alabama, PCTuscaloosaAlabama35406-
Arizona Arthritis & Rheumatology Associates, P.C.GlendaleArizona85306-
Arizona Arthritis & Rheumatology Research, PllcParadise ValleyArizona85253-
Sun Valley Arthritis CenterPeoriaArizona85381-
Valley Arthritis CarePhoenixArizona85027-
Advanced Arthritis Care & ResearchScottsdaleArizona85258-
Camp Lowell Medical SpecialistsTucsonArizona85715-
The University of ArizonaTucsonArizona85724-
NEA Baptist ClinicJonesboroArkansas72401-
OrthoArkansas; Orthopedics & Sports MedicineLittle RockArkansas72205-
Samy Metyas, MD, IncCovinaCalifornia91723-
Talbert Medical GroupHuntington BeachCalifornia92646-
Allergy & Rheumatology Medical Clinic, IncLa JollaCalifornia92037-
Valerius Medical GroupLos AlamitosCalifornia90720-
Clinical Interventions Research InstituteMission ViejoCalifornia92692-
Dr. Brigid Freyne, MDMurrietaCalifornia92563-
Sharp Rees-Stealy Medical GroupPowayCalifornia92064-
Purushotham & Akther Kotha IncSan DiegoCalifornia92120-
San Diego Arthritis Med ClncSan DiegoCalifornia92108-
C Michael Neuwelt MD IncSan LeandroCalifornia94578-
Pacific Arthritis Ctr Med GrpSanta MariaCalifornia93454-
Orrin M. Troum, MdSanta MonicaCalifornia90404-
Harbor UCLA Medical CenterTorranceCalifornia90509-
Inland Rheumatology; Clinical Trials, Inc.UplandCalifornia91786-
Medvin Clinical ResearchWhittierCalifornia90606-
Arthritis Assoc & Osteoporosis; Ctr of Colorado SpringsColorado SpringsColorado80920-
Joao NascimentoBridgeportConnecticut06606-
University of Connecticut Health CenterFarmingtonConnecticut06030-
Arthritis & Osteoporosis Center PcHamdenConnecticut06518-
ZASA Clinical ResearchBoynton BeachFlorida33472-
DC Health ClinicCoral GablesFlorida33134-
Tsai, YongDaytona BeachFlorida32117-
Jacksonville Center For Clinical ResearchJacksonvilleFlorida32216-
Pharmax Research Clinic Inc.MiamiFlorida33126-
Arthritis/Osteoporosis Treatment CenterOrange ParkFlorida32073-
Arthritis Rsrch of Florida, Inc.Palm HarborFlorida34684-
Baptist Hospital Clinical ResearchPensacolaFlorida32501-
Lovelace Scientific ResourcesSarasotaFlorida34292-
Centre for Arthritis and Rheumatic DiseasesSouth MiamiFlorida33143-
Pinellas Medical Research, LLCSt. PetersburgFlorida33708-
Healthpoint Medical group, IncTampaFlorida33614-
SW Florida Clinical ResearchTampaFlorida33609-
Arthritis & Rheumatology of GeorgiaAtlantaGeorgia30342-
Emory Uni ; Division of RheumatologyAtlantaGeorgia30303-
North Georgia RheumatologyDuluthGeorgia30096-
Harbin ClinicRomeGeorgia30165-
St. Joseph'S/Candler Health System, Inc.; Office of ResearchSavannahGeorgia31405-
Selah Medical CtrBoiseIdaho83704-
Sonora Clinical ResearchBoiseIdaho83702-
St. Luke's Intermountain Research CenterBoiseIdaho83702-
Coeur D'Alene Arthritis ClinicCoeur d'AleneIdaho83814-
Idaho Arthritis CenterMeridianIdaho83642-
Apex Medical Research, AMR, Inc.ChicagoIllinois60616-
University of Illinois at ChicagoChicagoIllinois60612-
Methodist Medical Center of IlinoisPeoriaIllinois61602-
Northern Indiana Research AllianceFort WayneIndiana46804-
Diagnostic Rheumatology & ResearchIndianapolisIndiana46227-
Memorial Medical Group Clinical ResearchSouth BendIndiana46601-
Graves Gilbert ClinicBowling GreenKentucky42101-
Research IntegrityOwensboroKentucky42303-
Arthritis & Diabetes Clinic, IncMonroeLouisiana71203-
Ochsner Health SystemNew OrleansLouisiana70121-
Rheumatology Associates of BaltimoreBaltimoreMaryland21286-
Osteoporosis & Clinical Trials CenterHagerstownMaryland21740-
Center For Rheumatology & Bone ResearchWheatonMaryland20902-
Phase Iii Clinical ResearchFall RiverMassachusetts02720-
Clinical Pharmacology Study GroupWorcesterMassachusetts01610-
UMass Memorial Medical CenterWorcesterMassachusetts01605-
Hurley Research CenterFlintMichigan48503-
Rheumatology, P.C.; Medical Arts BuildingKalamazooMichigan49009-
Advanced Rheumatology, PCLansingMichigan48910-
Northern Michigan Regional HospitalPetoskeyMichigan49770-
St. Paul RheumatologyEaganMinnesota55121-
Va Medical CenterMinneapolisMinnesota55417-
Mayo Clinic RochesterRochesterMinnesota55905-
Jackson Arthritis ClinicFlowoodMississippi39232-
North Mississippi Med Clinics, Inc.TupeloMississippi38801-
Glacier View Research InstituteKalispellMontana59901-
Univ of Nebraska Medical CtrOmahaNebraska68198-
Advanced Biomedical Research of AmericaLas VegasNevada89123-
Innovative Health ResearchLas VegasNevada89128-
Dartmouth-Hitchcock Medical Center, Rheumatology 5CLebanonNew Hampshire03756-
Nashua Rheumatology - Foundation Medical PartnersNashuaNew Hampshire03060-
Summit Medical GroupBerkeley HeightsNew Jersey07922-
Rheumatology Associates Of New JerseyTeaneckNew Jersey07666-
Arthritis Rheumatic & Back Disease AssociatesVoorhees TownshipNew Jersey08043-
Albuquerque Center For RheumatologyAlbuquerqueNew Mexico87102-
Arthritis and Osteoporosis Associates of New MexicoLas CrucesNew Mexico88011-
Arthritis & Osteoporosis Medical Associates, PllcBrooklynNew York11201-
SUNY Downstate Medical Center.BrooklynNew York11203-
DiGiovanna Inst for Med Ed&ResNorth MassapequaNew York11758-
Southern Tier Arthritis & RheumatismOleanNew York14760-
Arthritis Health Associates; Clinical ResearchSyracuseNew York13210-
Asheville Arthritis & Osteoporosis Center, PAAshevilleNorth Carolina28803-
Carolina Bone & Joint P.A.CharlotteNorth Carolina28210-
Joint & Muscle Research InstituteCharlotteNorth Carolina28204-
Durham RheumatologyDurhamNorth Carolina27704-
PMG Research of Hickory LLCHickoryNorth Carolina28602-
Shanahan Rheumatology & Immunology, PLLCRaleighNorth Carolina27617-
Specialty Medical Clinic and Research CenterSanfordNorth Carolina27330-
Carolina Arthritis Associates, PaWilmingtonNorth Carolina28401-
Trinity Health CenterMinotNorth Dakota58701-
Cincinnati Rheumatic Disease Study GroupCincinnatiOhio45219-
University Hospitals Case Medical CenterClevelandOhio44109-
Columbus Arthritis CenterColumbusOhio43215-
Ohio State Univ Med CenterColumbusOhio43210-
Clinical Research Source, Inc.ToledoOhio43606-
Toledo ClinicToledoOhio43623-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Ilumina Clinical AssociatesIndianaPennsylvania15701-
PMA Medical SpecialistsLimerickPennsylvania19468-
Pivotal Clinical Research, LlcPerkasiePennsylvania18944-
Arthritis GroupPhiladelphiaPennsylvania19152-
University of Pittsburgh Medical Center Health System; Infectious DiseasePittsburghPennsylvania15213-2582-
Allegheny RheumatologyWexfordPennsylvania15090-
Clinical Research Center of ReadingWyomissingPennsylvania19610-
Pennsylvania Regional Center for Arthritis and Osteoporosis ResearchWyomissingPennsylvania19610-
Columbia Arthritis Center (Partnership Practice)ColumbiaSouth Carolina29204-
South Carolina Research CenterMyrtle BeachSouth Carolina29572-
Brown ClinicWatertownSouth Dakota57201-
Ramesh Gupta - PPMemphisTennessee38119-
Amarillo Center For Clinical ResearchAmarilloTexas79124-
Adriana Pop-Moody MD Clinic PACorpus ChristiTexas78404-
Metroplex Clinical ResearchDallasTexas75231-
Leading Edge Research, PA; Office of Dr. BurbanoFort WorthTexas76109-
Houston Inst. For Clinical ResearchHoustonTexas77074-
Rheumatic Disease Clin Res CtrHoustonTexas77004-
Southwest RheumatologyMesquiteTexas75150-
Leading Edge Research, PA; Office of Dr. BurbanoRichardsonTexas75080-
Texas Arthritis Research CenterSan AntonioTexas78217-
Arthritis & Osteoporosis ClinicWacoTexas76710-
Arthritis and Rheumatic Disease AssociatesBurkeVirginia22015-
Sentara Medical GroupNorfolkVirginia23510-
Apex Clinical ResearchKennewickWashington99336-
Seattle Rheumatology AssociatesSeattleWashington98104-
Office of George Krick, MdTacomaWashington98405-
Rheum & Pulmonary ClinicBeckleyWest Virginia25801-
Mountain State Clinical ResearchClarksburgWest Virginia26301-
Arthritis Centre; Suite 103RacineWisconsin53406-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Uni Of Alabama,Birmingham; Medicine - Rheumatology· Birmingham, ALRheumatology Associates of North Alabama· Huntsville, ALClinical and Translational Research Center of Alabama, PC· Tuscaloosa, ALArizona Arthritis & Rheumatology Associates, P.C.· Glendale, AZArizona Arthritis & Rheumatology Research, Pllc· Paradise Valley, AZSun Valley Arthritis Center· Peoria, AZ

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