A Study of Baricitinib in Participants With Rheumatoid Arthritis

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT04086745
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Baricitinib — DRUG
    Administered orally.
  • TNF Inhibitor — DRUG
    Administered SC

Study Details

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).

Key Dates

Start date
Feb 14, 2020
Status verified
Jul 2025
Primary completion
May 19, 2025
Completion
May 19, 2025

Study Design

Enrollment
1,317 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib Low Dose
    Baricitinib administered orally.
  • Experimental: Baricitinib High Dose
    Baricitinib administered orally.
  • Active Comparator: TNF Inhibitor
    Adalimumab or etanercept administered subcutaneously (SC) per standard of care.

Primary Outcome Measure

Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [ Time Frame: Baseline through Study Completion (Approximately 5.5 Years) ]

Locations (119)

FacilityCityStateZIPSite coordinators
Arizona Research Clinic PLLCChandlerArizona85225-
Arizona Arthritis & Rheumatology Associates, P. C.MesaArizona85202-
Arizona Arthritis & Rheumatology ResearchParadise ValleyArizona85253-
Sun Valley Arthritis Center, LTDPeoriaArizona85381-
Arizona Arthritis & Rheumatology AssociatesPhoenixArizona85037-
Arthritis and Rheumatism AssociatesJonesboroArkansas72401-
Providence St. Joseph's Medical CenterBurbankCalifornia91505-
Hope Clinical Research, Inc.Canoga ParkCalifornia91303-
Medvin Clinical Research - CovinaCovinaCalifornia91722-
TriWest Research Associates LLCEl CajonCalifornia92020-
Newport Huntington Med GrpHuntington BeachCalifornia92648-
BioSolutions Clinical Research CenterLa MesaCalifornia91942-
Valerius Medical Group and Research Center of Greater Long BeachLos AlamitosCalifornia90720-
R. Srinivasan, M.D., Inc. dba Monterey Park Medical CenterMonterey ParkCalifornia91754-
ACRC StudiesPowayCalifornia92064-
Desert Medical AdvancesRancho MirageCalifornia92270-
Purushotham & Akther Kotha MD IncSan DiegoCalifornia92120-
East Bay Rheumatology Medical Group, IncSan LeandroCalifornia94578-
Providence Medical FoundationSanta RosaCalifornia95403-
Dan La, MD IncTujungaCalifornia91042-
Office: Dr Robin K DoreTustinCalifornia92780-
Inland Rheumatology & Osteoporosis Medical GroupUplandCalifornia91786-
Nazanin Firooz, MD Inc.West HillsCalifornia91307-
Medvin Clinical Research - WhittierWhittierCalifornia90602-
Danbury Clinical Research, LLCDanburyConnecticut06810-
Delaware ArthritisLewesDelaware19958-
Omega Research Debary, LLCDeBaryFlorida32713-
Cria Center for RheumatologyFort LauderdaleFlorida33334-
SIMED HealthGainesvilleFlorida32607-
GNP Research at Mark Jaffe, MDHollywoodFlorida33024-
Rheumatology Center Of Palm Beach, PllcLake WorthFlorida33467 2991-
Arthritis and Rheumatology Center of South FloridaMargateFlorida33063-
Felicidad Medical ResearchMiamiFlorida33185-
Miami Clinical ReserachMiamiFlorida33155-
Heuer MD ResearchOrlandoFlorida32819-
Rheumatology Associates of Central FloridaOrlandoFlorida32806-
UCF Health Lake Nona OrlandoOrlandoFlorida32827-
IRIS Research and Development, LLCPlantationFlorida33324-
BayCare Health System IncSt. PetersburgFlorida33705-
West Broward Rheumatology AssociatesTamaracFlorida33321-
Avita Clinical ResearchTampaFlorida33613-
Tampa Medical Group, P.A.TampaFlorida33614-
Florida Medical Clinic LLCZephyrhillsFlorida33542-7505-
Arthritis & Rheumatology of GeorgiaAtlantaGeorgia30342-
Arthritis Center of North GeorgiaGainesvilleGeorgia30501-
St Luke's Clinic - Intermountain OrthopaedicsBoiseIdaho83702-
Hinsdale Orthopaedics, Illinois Bone and JointHinsdaleIllinois60521-
OrthoillinoisRockfordIllinois61114-
Rockford Orthopedic AssociatesRockfordIllinois61107-
Greater Chicago Specialty Physicians, LLCSchaumburgIllinois60195-
Center of Robert HozmanSkokieIllinois60076-
Beacon Medical Group Clinical ResearchSouth BendIndiana46617-
Graves-Gilbert ClinicBowling GreenKentucky42101-
Western KY Rheumatology PLLCHopkinsvilleKentucky42240-
Accurate Clinical ResearchLake CharlesLouisiana70605-
Arthritis and Diabetes Clinic, Inc.MonroeLouisiana71203-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Klein and Associates MD, PACumberlandMaryland21502-
NECCR PrimaCare ResearchFall RiverMassachusetts02721-
Michigan Rheumatology GroupGrand BlancMichigan48439-
Pandit Rheumatology PCOkemosMichigan48864-
Jefferson City Medical GroupJefferson CityMissouri65109-
Clinvest Research LLCSpringfieldMissouri65807-
West County RheumatologySt LouisMissouri63131-
Lovelace Scientific ResourcesHendersonNevada89104-
Allied Clinical ResearchRenoNevada89519-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Arthritis Care Medical CenterSomersetNew Jersey08873-
Atlantic Coastal ResearchToms RiverNew Jersey08757-
Sahni Rheumatology & Therapy PCWest Long BranchNew Jersey07764-
NYU LangoneNew YorkNew York10016-
Medication ManagementGreensboroNorth Carolina27408-
PMG Research of Hickory, LLCHickoryNorth Carolina28601-
Cape Fear Arthritis CareLelandNorth Carolina28451-
Carolina Arthritis AssociatesWilmingtonNorth Carolina28401-
Cincinnati Arthritis AssociatesCincinnatiOhio45242-
Craig S Thompson MD LLCMarionOhio43302-
Paramount Medical ResearchMiddleburg HeightsOhio44130-
Arthritis & Rheumatology Center of Oklahoma PLLCOklahoma CityOklahoma73103-
Good Samaritan Hospital CorvallisCorvallisOregon97330-
Advanced Rheumatology and Arthritis Research Center, PCCranberry TownshipPennsylvania15090-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Pennsylvania Regional Center for Arthritis and Osteoporosis ResearchWyomissingPennsylvania19610-
Articularis Healthcare d/b/a/ Low Country Rheumatology, PANorth CharlestonSouth Carolina29406-
Monument Health Rapid City HospitalRapid CitySouth Dakota57701-
Cumberland RheumatologyCrossvilleTennessee38555-
West Tennessee Research InstituteJacksonTennessee38305-
Nashville Arthritis and RheumatologyNashvilleTennessee37203-
Accent Clinical Research Professionals, LLCAllenTexas75013-
Amarillo Center for Clinical ResearchAmarilloTexas79124-
Arthritis & Osteoporosis Clinic of Brazos ValleyCollege StationTexas77845-
Metroplex Clinical Research CenterDallasTexas75235-
El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research OrganizationEl PasoTexas79912-
Accurate Clinical Management - HoustonHoustonTexas77084-
Biopharma Informatic, LLCHoustonTexas77043-
Pioneer Research SolutionsHoustonTexas77008-
UDL Clinical Research, LLCHoustonTexas77002-
Houston Rheumatology & Arthritis SpecialistsKatyTexas77494-
R and H Clinical ResearchKatyTexas77494-
Synergy Group USKatyTexas77450-
Prime Clinical ResearchMansfieldTexas76063-
Southwest Rheumatology, P.A.MesquiteTexas75150-
Advanced Clinical Research Center of HoustonPearlandTexas77584-
Clinrx Research Joseph INC.PlanoTexas75007-
Violeta T. Baddour, MDPleasantonTexas78064-
Accurate Clinical Research, Inc.San AntonioTexas78229-
Accurate Clinical ManagementSugar LandTexas77479-
Fort Bend Clinical Research, LLCSugar LandTexas77479-
Mt. Olympus Medical ResearchSugar LandTexas77479-
Baylor Scott & White HealthTempleTexas76508-
North Houston Rheumatology AssociatesThe WoodlandsTexas77380-
Dynamed Clinical Research, LP d/b/a DM Clinical ResearchTomballTexas77375-
Center for Arthritis and Rheumatic Diseases, PCChesapeakeVirginia23320-
Spectrum Medical Inc.DanvilleVirginia24541-
Arthritis & Osteoporosis Center of Northern ViriniaManassasVirginia20109-
TPMG Rheumatology/TPMG Clinical ResearchNewport NewsVirginia23606-
Arthritis Northwest, PLLCSpokaneWashington99204-
Rheumatology & Pulmonary ClinicBeckleyWest Virginia25801-
Rheumatic Disease CenterMilwaukeeWisconsin53211-

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