Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT02092467
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • tofacitinib — DRUG
    Oral tablet, 5 mg BID
  • tofacitinib — DRUG
    Oral tablet, 10 mg BID
  • adalimumab — BIOLOGICAL
    Pre-filled syringe, 40 mg subcutaneous injection, every other week
  • etanercept — BIOLOGICAL
    Pre-filled syringe, 50 mg subcutaneous injection, every week

Study Details

This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.

Key Dates

Start date
Mar 14, 2014
Status verified
Jul 2021
Primary completion
Jul 22, 2020
Completion
Jul 22, 2020

Study Design

Enrollment
4,372 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 1
  • Experimental: Treatment Arm 2
  • Active Comparator: Treatment Arm 3
    TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.

Primary Outcome Measure

Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC) [ Time Frame: Baseline up to last contact date (maximum up to 72 months) ]

Locations (142)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention ProgramBirminghamAlabama35294-7201-
Rheumatology Associates of North Alabama, PCHuntsvilleAlabama35801-
Clinical and Translational Research Center of Alabama, PCTuscaloosaAlabama35406-
Southern Arizona VA Health Care System (SAVAHCS)TucsonArizona85723-
University of Arizona Clinical and Translational Science Research CenterTucsonArizona85724-
CHI St. Vincent Medical Group Hot SpringsHot SpringsArkansas71913-
Arthritis And Rheumatism Associates LLCJonesboroArkansas72401-
Medvin Clinical ResearchCovinaCalifornia91722-
Med Investigations, Inc.Fair OaksCalifornia95628-
Talbert Medical GroupHuntington BeachCalifornia92646-
University of California, San Diego (UCSD)- Perlman Ambulatory ClinicLa JollaCalifornia92037-
ProHealth PartnersLong BeachCalifornia90808-
Valerius Medical Group And Research Center Of Greater Long Beach, Inc.Long BeachCalifornia90806-
Keck Medicine of USCLos AngelesCalifornia90033-
California Medical Research Associates IncNorthridgeCalifornia91324-
Desert Medical AdvancesPalm DesertCalifornia92260-
Medvin Clinical ResearchPlacentiaCalifornia92870-
Sierra Rheumatology, Inc.RosevilleCalifornia95661-
San Diego Arthritis Medical ClinicSan DiegoCalifornia92108-
Dr. Orrin M. Troum, Md And Medical AssociatesSanta MonicaCalifornia90404-
Harbor UCLA Medical CenterTorranceCalifornia90509-
Los Angeles Biomedical Research Institute at Harbor UCLA Medical CenterTorranceCalifornia90502-
Robin K. Dore M.D., Inc.TustinCalifornia92780-
Medvin Clinical ResearchVan NuysCalifornia91405-
Ventura Clinical TrialsVenturaCalifornia93003-
Desert Valley Medical GroupVictorvilleCalifornia92395-
Medvin Clinical ResearchWhittierCalifornia90602-
Arthritis Associates and Osteoporosis Center of Colorado SpringsColorado SpringsColorado80920-
Howard University HospitalWashington D.C.District of Columbia20060-
RASF-Clinical Research Center, IncBoca RatonFlorida33486-
Bay Area Arthritis and OsteoporosisBrandonFlorida33511-
Arthritis & Rheumatism Associates (Private Practice)ClearwaterFlorida33756-
Dr.Robert W. Levin MDOffice ofClearwaterFlorida33765-
Florida Clinical Research Group (Administrative Office)ClearwaterFlorida33759-
International Medical ResearchDaytona BeachFlorida32117-
Centre for Rheumatology, Immunology and ArthritisFort LauderdaleFlorida33309-
University of Florida - Rheumatology at ACCJacksonvilleFlorida32207-
University of Florida College of Medicine, Jacksonville - Rheumatology ResearchJacksonvilleFlorida32207-
Center for Arthritis and Rheumatic DiseasesMiamiFlorida33173-
Doctors Research InstituteMiamiFlorida33145-
San Marcus Research ClinicMiami LakesFlorida33014-
Ocala Rheumatology Research CenterOcalaFlorida34474-
Advanced Clinical Research of OrlandoOcoeeFlorida34761-
Arthritis & osteoporosis treatment center,PAOrange ParkFlorida32073-
Omega Research Consultants, LLCOrlandoFlorida32810-
Rheumatology Associates of Central Florida, PAOrlandoFlorida32806-
Millennium ResearchOrmond BeachFlorida32174-
Arthritis Center, Inc.Palm HarborFlorida34684-
Arthritis Research of Florida, Inc.Palm HarborFlorida34684-
Advanced Medical Research CenterPort OrangeFlorida32127-
Advanced Urgent CarePort OrangeFlorida32127-
USF Health Morsani Center for Advanced HealthcareTampaFlorida33612-
Florida Medical Clinic, P.A.ZephyrhillsFlorida33542-
Arthritis and Rheumatology of GA, P.C.AtlantaGeorgia30342-
Medical Associates of North Georgia - RheumatologyCantonGeorgia30115-
Office of Jefrey D. Lieberman, MD, PCDecaturGeorgia30033-
Coeur D'Alene Arthritis ClinicCoeur d'AleneIdaho83814-
Quincy Medical GroupQuincyIllinois62301-
Springfield ClinicSpringfieldIllinois62702-
Diagnostic Rheumatology and Research PCIndianapolisIndiana46227-
MidWest Clinical Research, LLCOverland ParkKansas66209-
Professional Research Network of Kansas, LLCWichitaKansas67205-1138-
Arthritis and Diabetes Clinic, Inc.MonroeLouisiana71203-
Klein & Associates, M.D.,P.A.CumberlandMaryland21502-
Arthritis Treatment CenterFrederickMaryland21702-
Klein & Associates, MD, PAHagerstownMaryland21740-
The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PCWheatonMaryland20902-
Phase III Clinical ResearchFall RiverMassachusetts02720-
UMass Memorial Medical Center, Memorial CampusWorcesterMassachusetts01605-
Bronson Healthcare GroupBattle CreekMichigan49015-
Borgess Medical CenterKalamazooMichigan49048-
Borgess Research InstituteKalamazooMichigan49048-
Bronson Rheumatology SpecialistsKalamazooMichigan49007-
Jasper Clinic, Inc.KalamazooMichigan49007-
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical ResearchKalamazooMichigan49008-
June DO,PCLansingMichigan48910-
Shores Rheumatology P.C.Saint Clair ShoresMichigan48081-
St. Paul Rheumatology, PAEaganMinnesota55121-
Center for Diagnostic ImagingMendota HeightsMinnesota55118-
Mayo ClinicRochesterMinnesota55905-
Kansas City Internal MedicineKansas CityMissouri64114-
Clinvest Research, LLCSpringfieldMissouri65810-
Glacier View Research InstituteKalispellMontana59901-
Physician Research Collaboration, LLCLincolnNebraska68516-
Westroads Clinical Research, Inc.OmahaNebraska68114-
EKSAKTI, LLC (dba: Eksakti Clinical Research)Las VegasNevada89128-
Steinberg DiagnosticsLas VegasNevada89109-
University of Nevada School of MedicineLas VegasNevada89102-
Arthritis Center Of RenoRenoNevada89502-
Nashua RheumatologyNashuaNew Hampshire03060-
Summit Medical GroupCliftonNew Jersey07012-
Weill Cornell Physicians at Brooklyn HeightsBrooklynNew York11201-
Northwell Health Division of RheumatologyGreat NeckNew York11021-
NYU Langone Rheumatology Associates Long Island.Lake SuccessNew York11042-
EmergeOrtho,P.A.DurhamNorth Carolina27704-
Physicians East, PAGreenvilleNorth Carolina27834-
Frycare outpatient imaging CenterHickoryNorth Carolina28602-
PMG Research of Hickory LLCHickoryNorth Carolina28601-
PMG Research of Hickory, LLCHickoryNorth Carolina28602-
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCareStatesvilleNorth Carolina28625-
Carolina Arthritis AssociatesWilmingtonNorth Carolina28401-
St. Alexius Medical CenterBismarckNorth Dakota58501-
Trinity Health Center - Medical ArtsMinotNorth Dakota58701-
Cincinnati Rheumatic Disease Study Group, Inc.CincinnatiOhio45242-
STAT Research, Inc.DaytonOhio45417-
Health Research of OklahomaOklahoma CityOklahoma73103-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Oklahoma Medical Research Foundation (OMRF)Oklahoma CityOklahoma73104-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
The Arthritis GroupPhiladelphiaPennsylvania19152-
UPMC Arthritis and Autoimmunity ClinicPittsburghPennsylvania15213-
UPMC Lupus Center of ExcellencePittsburghPennsylvania15213-
Clinical Research Center of Reading, LLCWyomissingPennsylvania19610-
Rheumatology Associates, P.A.CharlestonSouth Carolina29407-
Innovative Clinical Research, LLCGreenvilleSouth Carolina29601-
Piedmont Arthritis Clinic, PAGreenvilleSouth Carolina29601-
Articluaris Healthcare Group d/b/a ACME ResearchOrangeburgSouth Carolina29118-
Articularis Healthcare Group, Inc d/b/a Low Country RheumatologySummervilleSouth Carolina29486-
West Tennessee Research InstituteJacksonTennessee38305-
Rheumatology Consultants, PLLCKnoxvilleTennessee37909-
Dr. Ramesh C. Gupta MD, Office ofMemphisTennessee38119-
Center For Inflammatory DiseaseNashvilleTennessee37203-
Amarillo Center for Clinical Research, Ltd.AmarilloTexas79124-
Austin Regional ClinicAustinTexas78731-
Trinity Universal Research Associates, IncCarrolltonTexas75007-
Pioneer Research Solutions, Inc.CypressTexas77429-
Arthritis Centers of TexasDallasTexas75246-
Baylor Scott and White Research Institute / Arthritis Care and Research CenterDallasTexas75231-
UT Southwestern Medical CenterDallasTexas75390-
Accurate Clinical Management, LLCHoustonTexas77004-
Accurate Clinical Management, LLCHoustonTexas77084-
Accurate Clinical Research, Inc.HoustonTexas77034-
Houston Institute for Clinical ResearchHoustonTexas77074-
Medical Center Research, LLCHoustonTexas77089-
Rheumatic Disease Clinical Research CenterHoustonTexas77004-
Accurate Clinical Research, Inc.League CityTexas77573-
Arthritis and Osteoporosis Associates, LLPLubbockTexas79424-
Southwest Rheumatology Research, LLCMesquiteTexas75150-
Trinity Universal Research Associates, Inc.PlanoTexas75024-
Center for Arthritis and Rheumatic Diseases, PCChesapeakeVirginia23320-
Center for Arthritis and Rheumatic Diseases, P.C.SuffolkVirginia23435-
Rheumatic Disease CenterGlendaleWisconsin53217-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program· Birmingham, ALRheumatology Associates of North Alabama, PC· Huntsville, ALClinical and Translational Research Center of Alabama, PC· Tuscaloosa, ALSouthern Arizona VA Health Care System (SAVAHCS)· Tucson, AZUniversity of Arizona Clinical and Translational Science Research Center· Tucson, AZCHI St. Vincent Medical Group Hot Springs· Hot Springs, AR

Related Studies