A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

Part of paid clinical trials in Flagstaff, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT03915964
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.

Key Dates

Start date
Apr 25, 2019
Status verified
Jul 2025
Primary completion
May 28, 2025
Completion
May 28, 2025

Study Design

Enrollment
2,663 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 (81)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology Research, PLLCFlagstaffArizona86001-
Arthrocare, Arthritiscare & Research PcGilbertArizona85234-
Arizona Arthritis & Rheumatology Research, PLLCGlendaleArizona85306-
Arizona Arthritis & Rheumatology Research, PLLCMesaArizona85210-
Hope Research InstitutePeoriaArizona85381-
Hope Research InstitutePhoenixArizona85018-
Arizona Arthritis & Rheumatology Research, PLLCTucsonArizona85704-
Medvin Clinical Research - CovinaCovinaCalifornia91722-
St Joseph Heritage HealthcareFullertonCalifornia92835-
Christine Thai, MDHuntington BeachCalifornia92648-
Private Practice - Dr. Christine J. LeehealeyIrvineCalifornia92604-
Desert Medical AdvancesRancho MirageCalifornia92270-
Rheumatology Center of San DiegoSan DiegoCalifornia92128-
East Bay Rheumatology Medical Group, IncSan LeandroCalifornia94578-
Dan La, MD IncTujungaCalifornia91042-
Robin K. Dore MD, IncTustinCalifornia92780-
Inland Rheumatology & Osteoporosis Medical GroupUplandCalifornia91786-
Medvin Clinical Research - WeidmannVan NuysCalifornia91405-
Medvin Clinical Research - WhittierWhittierCalifornia90602-
Stamford Therapeutics ConsortiumStamfordConnecticut06905-
Rheumatology Associates of South FloridaBoca RatonFlorida33486-
New Horizon Research CenterMiamiFlorida33165-
Suncoast Research GroupMiamiFlorida33135-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
IRIS Research and Development, LLCPlantationFlorida33324-
Qps-Mra, LlcSouth MiamiFlorida33143-
ForCare Clinical ResearchTampaFlorida33613-
Arthritis & Rheumatology of GeorgiaAtlantaGeorgia30342-
Arthritis Center of North GeorgiaGainesvilleGeorgia30501-
St. Luke's Intermountain Research CenterBoiseIdaho83702-
Great Lakes Clinical TrialsChicagoIllinois60640-
Qualmedica Research, LLCEvansvilleIndiana47715-
Alliance for Multispecialty Research, LLCWichitaKansas67205-
Center for Arthritis and OsteoporosisElizabethtownKentucky42701-
Accurate Clinical ResearchLake CharlesLouisiana70605-
The Center for Rheumatology and Bone ResearchWheatonMaryland20902-
NECCR PrimaCare ResearchFall RiverMassachusetts02721-
University of MichiganBrightonMichigan48116-
West Michigan RheumatologyGrand RapidsMichigan49546-
Advanced Rheumatology, PCOkemosMichigan48864-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Clinvest Research LLCSpringfieldMissouri65807-
Glacier View Research InstituteKalispellMontana59901-
Physician Research Collaboration, LLCLincolnNebraska68516-
Westroads Clinical Research, Inc.OmahaNebraska68114-
Allied Clinical ResearchRenoNevada89519-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Albuquerque Center for RheumatologyAlbuquerqueNew Mexico87102-
Albuquerque Clinical Trials, Inc.AlbuquerqueNew Mexico87102-
Santa Fe RheumatologySanta FeNew Mexico87505-
Accellacare - CharlotteCharlotteNorth Carolina28211-
M3-Emerging Medical Research, LLCDurhamNorth Carolina27704-
Piedmont Rheumatology, P.A.HickoryNorth Carolina28602-
Cape Fear Arthritis CareLelandNorth Carolina28451-
PMG Research of SalisburySalisburyNorth Carolina28144-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
Cincinnati Rheumatic Disease Study GroupCincinnatiOhio45242-
Marietta Memorial HospitalMariettaOhio45750-
Paramount Medical Research & Consulting, LLCMiddleburg HeightsOhio44130-
Health Research of OklahomaOklahoma CityOklahoma73103-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-
East Penn Rheumatology AssociatesBethlehemPennsylvania18015-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Clinical Research Center of Reading,LLCWyomissingPennsylvania19610-
Pennsylvania Regional Center for Arthritis and Osteoporosis ResearchWyomissingPennsylvania19610-
Regional Health Clinical ResearchRapid CitySouth Dakota57701-
Accurate Clinical ManagementBaytownTexas77521-
Arthritis & Osteoporosis Clinic of Brazos ValleyCollege StationTexas77845-
Accurate Clinical Management - HoustonHoustonTexas77084-
Accurate Clinical ResearchHoustonTexas77089-
Biopharma Informatic, LLCHoustonTexas77043-
Research Physicians Network, LLCHoustonTexas77089-
Accurate Clinical ResearchLeague CityTexas77573-
Accurate Clinical Research, Inc.San AntonioTexas78229-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
Accurate Clinical ManagementSugar LandTexas77479-
DM Clinical Research/Rheumatology Clinic of HoustonTomballTexas77377-
Dynamed Clinical Research, LP d/b/a DM Clinical ResearchTomballTexas77375-
Arthritis Northwest, PLLCSpokaneWashington99204-
The Vancouver ClinicVancouverWashington98664-
CAMC Health Education and Research Institute IncCharlestonWest Virginia25304-

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