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NCT04086745CompletedPhase 4

A Study of Baricitinib in Participants With Rheumatoid Arthritis

A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1050 (actual)
First submitted
10 Sept 2019
Start date
14 Feb 2020
Primary completion date
19 May 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT04086745

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 1050
  • From 14 Feb 2020 to the primary completion date, 19 May 2025
  • 119 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:
    • discontinued for lack or loss of efficacy for RA, or
    • discontinued for intolerance (AE) when used for any indication
  • Participants must not have had a live vaccine within four weeks of study start

Other illness

  • Participants must not have cancer
  • Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness
  • Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year

Other

  • Participants must not be pregnant or breastfeeding
  • Participants must not have had more than one VTE
  • Participants must not have participated in any other clinical trial within four weeks of study start

Who the study is looking for

  • Participants must have at least one of the following characteristics:
    • Documented evidence of a VTE prior to this study
    • At least 60 years of age
    • A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
    • Age 50 to less than 60 years and BMI 25 to less than 30 kg/m²
  • Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (DMARD) (synthetic or biologic)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (119)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Accent Clinical Research Professionals, LLC
Coordinator of this site? Confirm its status
AllenUnited StatesUnknown status
Amarillo Center For Clinical Research
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AmarilloUnited StatesUnknown status
Arthritis & Rheumatology of Georgia
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AtlantaUnited StatesUnknown status
Rheumatology & Pulmonary Clinic
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BeckleyUnited StatesUnknown status
St Luke's Clinic - Intermountain Orthopaedics
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BoiseUnited StatesUnknown status
Graves Gilbert Clinic
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Bowling GreenUnited StatesUnknown status
Providence St. Joseph's Medical Center
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BurbankUnited StatesUnknown status
Hope Clinical Research, Inc.
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Canoga ParkUnited StatesUnknown status
Arizona Research Clinic PLLC
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ChandlerUnited StatesUnknown status
Center for Arthritis and Rheumatic Diseases, PC
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ChesapeakeUnited StatesUnknown status
Cincinnati Arthritis Associates
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CincinnatiUnited StatesUnknown status
Arthritis & Osteoporosis Clinic of Brazos Valley
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College StationUnited StatesUnknown status
Good Samaritan Hospital Corvallis
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CorvallisUnited StatesUnknown status
Medvin Clinical Research - Covina
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CovinaUnited StatesUnknown status
Advanced Rheumatology and Arthritis Research Center, PC
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Cranberry TownshipUnited StatesUnknown status
Cumberland Rheumatology
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CrossvilleUnited StatesUnknown status
Klein and Associates MD, PA
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CumberlandUnited StatesUnknown status
Metroplex Clinical Research Center
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DallasUnited StatesUnknown status
Danbury Clinical Research, LLC
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DanburyUnited StatesUnknown status
Spectrum Medical, Inc.
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DanvilleUnited StatesUnknown status
Omega Research Debary, LLC
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DeBaryUnited StatesUnknown status
Altoona Center For Clinical Research
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DuncansvilleUnited StatesUnknown status
TriWest Research Associates LLC
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El CajonUnited StatesUnknown status
El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
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El PasoUnited StatesUnknown status
NECCR PrimaCare Research
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Fall RiverUnited StatesUnknown status
Cria Center for Rheumatology
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Fort LauderdaleUnited StatesUnknown status
Arthritis Center of North Georgia
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GainesvilleUnited StatesUnknown status
SIMED Health
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GainesvilleUnited StatesUnknown status
Michigan Rheumatology Group
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Grand BlancUnited StatesUnknown status
Medication Management
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GreensboroUnited StatesUnknown status
Lovelace Scientific Resources
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HendersonUnited StatesUnknown status
PMG Research of Hickory, LLC
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HickoryUnited StatesUnknown status
Hinsdale Orthopaedics, Illinois Bone and Joint
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HinsdaleUnited StatesUnknown status
GNP Research at Mark Jaffe, MD
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HollywoodUnited StatesUnknown status
Western KY Rheumatology PLLC
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HopkinsvilleUnited StatesUnknown status
Pioneer Research Solutions
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HoustonUnited StatesUnknown status
Accurate Clinical Management - Houston
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HoustonUnited StatesUnknown status
Biopharma Informatic, LLC
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HoustonUnited StatesUnknown status
UDL Clinical Research, LLC
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HoustonUnited StatesUnknown status
Newport Huntington Med Grp
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Huntington BeachUnited StatesUnknown status
West Tennessee Research Institute
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JacksonUnited StatesUnknown status
Jefferson City Medical Group
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Jefferson CityUnited StatesUnknown status
Arthritis and Rheumatism Associates
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JonesboroUnited StatesUnknown status
Synergy Group US
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KatyUnited StatesUnknown status
Houston Rheumatology & Arthritis Specialists
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KatyUnited StatesUnknown status
R and H Clinical Research
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KatyUnited StatesUnknown status
Accurate Clinical Research
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Lake CharlesUnited StatesUnknown status
Rheumatology Center Of Palm Beach, Pllc
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Lake WorthUnited StatesUnknown status
Biosolutions Clinical Research Center
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La MesaUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
Cape Fear Arthritis Care
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LelandUnited StatesUnknown status
Delaware Arthritis
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LewesUnited StatesUnknown status
Valerius Medical Group and Research Center of Greater Long Beach
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Los AlamitosUnited StatesUnknown status
Arthritis & Osteoporosis Center of Northern Virinia
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ManassasUnited StatesUnknown status
Prime Clinical Research
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MansfieldUnited StatesUnknown status
Arthritis and Rheumatology Center of South Florida
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MargateUnited StatesUnknown status
Craig S Thompson MD LLC
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MarionUnited StatesUnknown status
Arizona Arthritis & Rheumatology Associates, P. C.
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MesaUnited StatesUnknown status
Southwest Rheumatology, P.A.
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MesquiteUnited StatesUnknown status
Felicidad Medical Research
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MiamiUnited StatesUnknown status
Miami Clinical Reserach
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MiamiUnited StatesUnknown status
Paramount Medical Research
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Middleburg HeightsUnited StatesUnknown status
Rheumatic Disease Center
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MilwaukeeUnited StatesUnknown status
Arthritis And Diabetes Clinic, Inc.
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MonroeUnited StatesUnknown status
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
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Monterey ParkUnited StatesUnknown status
Nashville Arthritis and Rheumatology
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NashvilleUnited StatesUnknown status
Ochsner Clinic Foundation
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New OrleansUnited StatesUnknown status
TPMG Rheumatology/TPMG Clinical Research
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Newport NewsUnited StatesUnknown status
NYU Langone
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New YorkUnited StatesUnknown status
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
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North CharlestonUnited StatesUnknown status
Pandit Rheumatology PC
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OkemosUnited StatesUnknown status
Arthritis & Rheumatology Center of Oklahoma PLLC
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Oklahoma CityUnited StatesUnknown status
Heuer MD Research
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OrlandoUnited StatesUnknown status
Rheumatology Associates of Central Florida
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OrlandoUnited StatesUnknown status
UCF Health Lake Nona Orlando
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OrlandoUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research
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Paradise ValleyUnited StatesUnknown status
Advanced Clinical Research Center of Houston
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PearlandUnited StatesUnknown status
Sun Valley Arthritis Center Ltd
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PeoriaUnited StatesUnknown status
Arizona Arthritis & Rheumatology Associates
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PhoenixUnited StatesUnknown status
Clinrx Research Joseph INC.
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PlanoUnited StatesUnknown status
IRIS Research and Development LLC
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PlantationUnited StatesUnknown status
Violeta T. Baddour, MD
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PleasantonUnited StatesUnknown status
ACRC Studies
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PowayUnited StatesUnknown status
Desert Medical Advances
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Rancho MirageUnited StatesUnknown status
Monument Health Rapid City Hospital
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Rapid CityUnited StatesUnknown status
Allied Clinical Research
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RenoUnited StatesUnknown status
OrthoIllinois
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RockfordUnited StatesUnknown status
Rockford Orthopedic Associates
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RockfordUnited StatesUnknown status
Accurate Clinical Research, Inc.
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San AntonioUnited StatesUnknown status
Purushotham & Akther Kotha MD Inc
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San DiegoUnited StatesUnknown status
East Bay Rheumatology Medical Group, Inc
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San LeandroUnited StatesUnknown status
Providence Medical Foundation
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Santa RosaUnited StatesUnknown status
Greater Chicago Specialty Physicians, LLC
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SchaumburgUnited StatesUnknown status
Center of Robert Hozman
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SkokieUnited StatesUnknown status
Arthritis Care Medical Center
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SomersetUnited StatesUnknown status
Beacon Medical Group Clinical Research
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South BendUnited StatesUnknown status
Arthritis Northwest, PLLC
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SpokaneUnited StatesUnknown status
Clinvest Research, LLC
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SpringfieldUnited StatesUnknown status
West County Rheumatology
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St LouisUnited StatesUnknown status
BayCare Health System Inc
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St. PetersburgUnited StatesUnknown status
Mt. Olympus Medical Research
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Sugar LandUnited StatesUnknown status
Fort Bend Clinical Research, LLC
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Sugar LandUnited StatesUnknown status
Accurate Clinical Management
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Sugar LandUnited StatesUnknown status
West Broward Rheumatology Associates
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TamaracUnited StatesUnknown status
Tampa Medical Group, P.A.
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TampaUnited StatesUnknown status
Avita Clinical Research
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TampaUnited StatesUnknown status
Baylor Scott & White Health
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TempleUnited StatesUnknown status
North Houston Rheumatology Associates
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The WoodlandsUnited StatesUnknown status
Dynamed Clinical Research, LP d/b/a DM Clinical Research
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TomballUnited StatesUnknown status
Atlantic Coastal Research
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Toms RiverUnited StatesUnknown status
Dan La, MD Inc
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TujungaUnited StatesUnknown status
Office: Dr Robin K Dore
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TustinUnited StatesUnknown status
Inland Rheumatology & Osteoporosis Medical Group
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UplandUnited StatesUnknown status
Nazanin Firooz, MD Inc.
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West HillsUnited StatesUnknown status
Sahni Rheumatology & Therapy PC
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West Long BranchUnited StatesUnknown status
Medvin Clinical Research - Whittier
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WhittierUnited StatesUnknown status
Carolina Arthritis Associates
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WilmingtonUnited StatesUnknown status
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
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WyomissingUnited StatesUnknown status
Florida Medical Clinic, LLC
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ZephyrhillsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.