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

A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Baricitinib; Drug: TNF Inhibitor

• Study Type: Interventional
• Enrollment (Actual): 2663
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Optimus Clinical Research
    • Newcastle, New South Wales, Australia, 2292
      • Genesis Research Services
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Rheumatology Research Unit
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Southern Clinical Research
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
• Austria
  • Wien, Austria, 1100
    • Rheuma-Zentrum Oberlaa GmbH
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universität Wien
    • Vienna, Wien, Austria, 1160
      • Wilhelminenspital
• Belgium
  • Bruxelles-Capitale, Région De
    • Brussels, Bruxelles-Capitale, Région De, Belgium, 1070
      • Université Libre de Bruxelles - Hôpital Erasme
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Reuma Clinic, Locatie Jaarbeurslaan
  • Vlaams Gewest
    • Merksem, Vlaams Gewest, Belgium, 2170
      • ZNA Jan Palfijn
• Czechia
  • Praha 11, Czechia, 14800
    • Affidea Praha, s.r.o.
  • Praha 4, Czechia, 14000
    • Revmatologicka ambulance
  • Brno-město
    • Brno, Brno-město, Czechia, 63800
      • Revmatologie.s.r.o.
    • Brno, Brno-město, Czechia, 61500
      • Revmacentrum MUDr. Mostera, s.r.o.
  • Jihomoravský Kraj
    • Brno, Jihomoravský Kraj, Czechia, 61141
      • REVMACLINIC s.r.o.
  • Moravskoslezský Kraj
    • Ostrava, Moravskoslezský Kraj, Czechia, 722 00
      • Artroscan, s.r.o.
  • Ostrava Město
    • Ostrava, Ostrava Město, Czechia, 70300
      • INREA s.r.o.
  • Pardubický Kraj
    • Pardubice, Pardubický Kraj, Czechia, 53002
      • Arthrohelp S.R.O.
  • Praha 10
    • Praha, Praha 10, Czechia, 100 00
      • CLINTRIAL s.r.o.
  • Praha 4
    • Praha, Praha 4, Czechia, 140 00
      • Revmatologie MUDr. Štejfová
  • Praha, Hlavní Mešto
    • Praha 2, Praha, Hlavní Mešto, Czechia, 12850
      • Revmatologicky Ustav
  • Zlínský Kraj
    • Uherske Hradiste, Zlínský Kraj, Czechia, 686 01
      • Medical Plus
    • Zlín, Zlínský Kraj, Czechia, 760 01
      • PV Medical Services s.r.o.
• Denmark
  • Midtjylland
    • Silkeborg, Midtjylland, Denmark, 8600
      • Regionshospitalet Silkeborg
  • Syddanmark
    • Svendborg, Syddanmark, Denmark, 5700
      • Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital
• France
  • Caluire et Cuire, France, 69300
    • Infirmerie Protestante de Lyon
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
  • Paris, France, 75013
    • Pitie Salpetriere University Hospital
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • CHU de Nice
  • Alsace
    • Strasbourg, Alsace, France, 67098
      • CHU Strasbourg-Hautepierre
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33076
      • Bordeaux University Hospital - Pellegrin
  • Centre
    • Orléans, Centre, France, 45067
      • Centre Hospitalier Régional D'orléans
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Hôpital Pierre-Paul Riquet
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Meurthe-et-Moselle
    • Vandoeuvre lès Nancy, Meurthe-et-Moselle, France, 54511
      • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69003
      • Hôpital Edouard Herriot
  • Vendée
    • La Roche-sur-Yon, Vendée, France, 85000
      • CHD Vendée
• Germany
  • Berlin, Germany, 14059
    • Schlosspark Klinik
  • Berlin, Germany, 12163
    • Praxis für Rheumatologie und Innere
  • Hamburg, Germany, 22391
    • Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz
  • Hamburg, Germany, 20095
    • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
  • Mecklenburg-Vorpommern
    • Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
      • Rheumazentrum Prof.Neeck MVZ
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Universitaetsklinikum Koeln
    • Ratingen, Nordrhein-Westfalen, Germany, 40878
      • Rheumazentrum Ratingen Studienambulanz
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39110
      • Institut für Präventive Medizin & Klinische Forschung GbR
• Greece
  • Attikí
    • Chaidari, Attikí, Greece, 12462
      • Attikon General University Hospital
  • Kentrikí Makedonía
    • Thessaloniki, Kentrikí Makedonía, Greece, 54642
      • Ippokrateio General Hospital of Thessaloniki
  • Évros
    • Alexanroupolis, Évros, Greece, 68100
      • University Hospital of Alexandroupolis
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
  • Borsod-Abaúj-Zemplén
    • Miskolc, Borsod-Abaúj-Zemplén, Hungary, 3529
      • CRU Hungary Kft.
  • Pest
    • Budapest, Pest, Hungary, 1027
      • Revita Clinic
    • Budapest, Pest, Hungary, 1033
      • ClinExpert Kft.
  • Veszprém City
    • Veszprem, Veszprém City, Hungary, 8200
      • Vital Medical Center
• Israel
  • HaDarom
    • Ashkelon, HaDarom, Israel, 7830604
      • Barzilai Medical Center
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center
    • Ramat Gan, HaMerkaz, Israel, 5262100
      • Sheba Medical Center
  • Tell Abīb
    • Tel Aviv, Tell Abīb, Israel, 6423906
      • Sourasky Medical Center
  • Ḥeifā
    • Haifa, Ḥeifā, Israel, 3109601
      • Rambam Health Care Campus
    • Haifa, Ḥeifā, Israel, 3436212
      • Carmel Hospital
    • Haifa, Ḥeifā, Israel
      • Bnai Zion Medical Center
• Italy
  • Firenze, Italy, 50141
    • Azienda Ospedaliera Universitaria Careggi
  • Napoli, Italy, 80131
    • University of Campania Luigi Vanvitelli
  • Verona, Italy, 37100
    • Policlinico GB Rossi Borgo Roma
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66013
      • Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
  • Milano
    • Milan, Milano, Italy, 20157
      • Ospedale Luigi Sacco
  • Toscana
    • Siena, Toscana, Italy, 53100
      • Ospedale Le Scotte
• Lithuania
  • Vilnius, Lithuania, 01117
    • Centro poliklinika
  • Kauno Miestas
    • Kaunas, Kauno Miestas, Lithuania, 45130
      • Republican Hospital of Kaunas
  • Šiauliai
    • Siauliai, Šiauliai, Lithuania, 76231
      • Respublikin Šiauli ligonin
• Netherlands
  • Fryslân
    • Leeuwarden, Fryslân, Netherlands, 8934 AD
      • Medische Centrum Leeuwarden
  • Limburg
    • Born, Limburg, Netherlands, 6121 XK
      • PT&R / PreCare Trial & Recruitment
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • MICS Centrum Medyczne Torun
  • Lubelskie
    • Tomaszów Lubelski, Lubelskie, Poland, 22-600
      • Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
  • Lubuskie
    • Nowa Sol, Lubuskie, Poland, 67-100
      • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Mazowieckie
    • Nadarzyn, Mazowieckie, Poland, 05-830
      • NZOZ Lecznica MAK-MED S.C.
    • Warszawa, Mazowieckie, Poland, 00-874
      • Medycyna Kliniczna
    • Warszawa, Mazowieckie, Poland, 03-291
      • Centrum Medyczne AMED Warszawa Targowek
    • Warszawa, Mazowieckie, Poland, 02-118
      • Rheuma Medicus- Zak��ad Opieki Zdrowotnej
    • Warszawa, Mazowieckie, Poland, 02-665
      • Centrum Medyczne Reuma Park
    • Warszawa, Mazowieckie, Poland, 02-677
      • ETG Warszawa
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-351
      • Osteo Medic sc A. Racewicz, J. Supronik
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Warmińsko-mazurskie
    • Elblag, Warmińsko-mazurskie, Poland, 82-300
      • Ambulatorium Barbara Bazela
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-397
      • Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj
    • Poznan, Wielkopolskie, Poland, 61-113
      • Ai Centrum Medyczne Sp. Z O.O.
  • Śląskie
    • Bytom, Śląskie, Poland, 41-902
      • BIF-MED
    • Katowice, Śląskie, Poland, 40-081
      • Centrum Medyczne Pratia Katowice
    • Ustron, Śląskie, Poland, 43-450
      • Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Centro Reumatologico Caguas
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc.
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC - Hato Rey Site
• Romania
  • Brașov
    • Brasov, Brașov, Romania, 500283
      • C.M.D.T.A. Neomed
  • Brăila
    • Braila, Brăila, Romania, 810019
      • Cmi Cristei Dorica
  • București
    • Bucharest, București, Romania, 014142
      • Delta Health Care
    • Bucharest, București, Romania, 011172
      • Spital Clinic Sf. Maria
    • Bucuresti, București, Romania, 30463
      • CCBR Clinical Research
  • Galați
    • Galati, Galați, Romania, 800578
      • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
  • Iași
    • Iasi, Iași, Romania, 707027
      • RK Medcenter
  • Maramureș
    • Baia Mare, Maramureș, Romania, 430031
      • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
  • Vâlcea
    • Râmnicu Vâlcea, Vâlcea, Romania, 240762
      • Sc Medaudio-Optica Srl
• Russian Federation
  • Petrozavodsk, Russian Federation, 185019
    • Karelia Republican Hospital V.A. Baranova
  • Saratov, Russian Federation, 410053
    • Regional Clinical Hospital of the Saratov Region
  • Yaroslavl, Russian Federation, 150003
    • Research & Practice
  • Kurskaya Oblast'
    • Kursk, Kurskaya Oblast', Russian Federation, 305007
      • Kursk Regional Clinical Hospital
  • Leningradskaya Oblast'
    • Saint-Petersburg, Leningradskaya Oblast', Russian Federation, 194291
      • Gbuz Lokb
  • Moskovskaya Oblast'
    • Moscow, Moskovskaya Oblast', Russian Federation, 119991
      • First Moscow State Medical University I.M. Sechenov
  • Moskva
    • Moscow, Moskva, Russian Federation, 129110
      • M. F. Vladimirskiy Moscow Regional Research Clinical Institute
    • Moscow, Moskva, Russian Federation, 111123
      • Moscow Clinical Research Center
    • Moscow, Moskva, Russian Federation, 115522
      • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
  • Nizhegorodskaya Oblast'
    • Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603005
      • Nizhny Novgorod City Clinical Hospital Number 5
  • Ryazanskaya Oblast'
    • Ryazan, Ryazanskaya Oblast', Russian Federation, 390026
      • Ryazan Regional Clinical Cardiological Dispensary
  • Sankt-Peterburg
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 190068
      • Clinical Rheumatology hospital #25
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 191015
      • North-Western State Medical University named after I.I.Mechnikov
  • Tul'skaya Oblast'
    • Tula, Tul'skaya Oblast', Russian Federation, 300053
      • Tula Regional Clinical Hospital
  • Ul'yanovskaya Oblast'
    • Ulianovsk, Ul'yanovskaya Oblast', Russian Federation, 432063
      • GUZ UOKB
• Slovakia
  • Banskobystrický Kraj
    • Zvolen, Banskobystrický Kraj, Slovakia, 960 01
      • ALBAMED s.r.o.
  • Bratislavský Kraj
    • Bratislava, Bratislavský Kraj, Slovakia, 851 01
      • ROMJAN s.r.o.
  • Košický Kraj
    • Kosice, Košický Kraj, Slovakia, 040 11
      • Artromac n.o.
    • Spisska Nova Ves, Košický Kraj, Slovakia, 05201
      • REUMED s.r.o.
  • Nitriansky Kraj
    • Topolcany, Nitriansky Kraj, Slovakia, 955 01
      • LERAM s.r.o.
  • Trenčiansky Kraj
    • Partizanske, Trenčiansky Kraj, Slovakia, 958 01
      • Reumacentrum s.r.o.
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6045
      • Netcare Greenacres Hospital
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Iatros International
    • Bloemfontein, Free State, South Africa, 9301
      • FARMOVS
  • Gauteng
    • Kempton Park, Gauteng, South Africa, 1619
      • Clinresco Centres
    • Pretoria, Gauteng, South Africa, 0001
      • University of Pretoria - Faculty of Health Sciences
  • Kwazulu-Natal
    • Chatsworth, Kwazulu-Natal, South Africa, 4092
      • Precise Clinical Solutions
    • Umhlanga, Kwazulu-Natal, South Africa, 4320
      • Netcare Umhlanga Hospital
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7405
      • Arthritis Clinical Trial Centre
    • Stellenbosch, Western Cape, South Africa, 7600
      • Winelands Medical Research Centre
• Spain
  • Córdoba, Spain, 14004
    • Hospital Quirónsalud Córdoba
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41010
    • Hospital Quiron Infanta Luisa
  • A Coruña [La Coruña]
    • A Coruña, A Coruña [La Coruña], Spain, 15006
      • Complejo Hospitalario Universitario A Coruna
    • Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
      • Clínica Gaias - Santiago
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Hospital General Universitario de Elche
    • Villajoyosa, Alicante, Spain, 03570
      • Hospital Marina Baixa
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08036
      • Hospital Clinic de Barcelona
    • Barcelona, Catalunya [Cataluña], Spain, 08022
      • Clinica Sagrada Familia
    • Barcelona, Catalunya [Cataluña], Spain, 08023
      • Hospital Quiron Barcelona
    • Sabadell, Catalunya [Cataluña], Spain, 08208
      • Corporacio Sanitaria Parc Tauli
    • Sant Joan Despí, Catalunya [Cataluña], Spain, 08970
      • Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
  • Córdoba
    • Cordoba, Córdoba, Spain, 14004
      • HU Reina Sofia
  • Galicia [Galicia]
    • Santiago de Compostela, Galicia [Galicia], Spain, 15706
      • CHUS - Hospital Clinico Universitario
  • Madrid, Comunidad De
    • Fuenlabrada, Madrid, Comunidad De, Spain, 28944
      • Hospital Universitario de Fuenlabrada
    • Getafe, Madrid, Comunidad De, Spain, 28905
      • Hospital Universitario Getafe
    • Majadahonda, Madrid, Comunidad De, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
  • País Vasco
    • Bilbo, País Vasco, Spain, 48013
      • Osi Bilbao-Basurto
  • Pontevedra [Pontevedra]
    • Vigo, Pontevedra [Pontevedra], Spain, 36200
      • CHUVI- Hospital do Meixoeiro
• Switzerland
  • Fribourg, Switzerland, 1708
    • HFR Fribourg - Hôpital Cantonal
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4056
      • University Hospital Basel
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Cantonal Hospital St.Gallen
• Turkey
  • Edirne, Turkey, 22030
    • Trakya University
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
  • Izmir, Turkey, 35620
    • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
  • Konya, Turkey
    • Necmettin Erbakan Meram Medical Fac.
  • Eskişehir
    • Eskisehir, Eskişehir, Turkey, 26480
      • Eskisehir Osmangazi University
  • İstanbul
    • Stanbul, İstanbul, Turkey, 34899
      • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
• United Kingdom
  • Liverpool, United Kingdom, L9 7AL
    • Aintree University Hospital NHS Foundation Trust
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • Bournemouth
    • Christchurch, Bournemouth, United Kingdom, BH23 2JX
      • Christchurch Hospital
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Derriford Hospital
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Torbay Hospital
  • England
    • Dudley, England, United Kingdom, DY1 2HQ
      • The Dudley Group NHS Foundation Trust
    • London, England, United Kingdom, NW32QG
      • Royal Free London NHS Foundation Trust
    • Truro, England, United Kingdom, TR1 3LJ
      • The Royal Cornwall Hospital
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • Mid Essex Hospital Services NHS Trust
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Queen Alexandra Hospital
  • Kingston Upon Hull
    • Hull, Kingston Upon Hull, United Kingdom, HU3 2JZ
      • Hull and East Yorkshire Hospitals NHS Trust
  • North Tyneside
    • Newcastle upon Tyne, North Tyneside, United Kingdom, NE29 8NH
      • Northumbria Healthcare NHS Foundation Trust
  • Nottinghamshire
    • Sutton In Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
      • King's Mill Hospital
  • Waltham Forest
    • London, Waltham Forest, United Kingdom, E11 1NR
      • Barts Health NHS Trust - Whipps Cross University Hospital
• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Gilbert, Arizona, United States, 85234
      • Arthrocare, Arthritiscare & Research Pc
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Peoria, Arizona, United States, 85381
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
    • Tucson, Arizona, United States, 85704
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research - Covina
    • Fullerton, California, United States, 92835
      • St Joseph Heritage Healthcare
    • Huntington Beach, California, United States, 92648
      • Christine Thai, MD
    • Irvine, California, United States, 92604
      • Private Practice - Dr. Christine J. Leehealey
    • Rancho Mirage, California, United States, 92270
      • Desert Medical Advances
    • San Diego, California, United States, 92128
      • Rheumatology Center of San Diego
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical Group, Inc
    • Tujunga, California, United States, 91042
      • Dan La, MD Inc
    • Tustin, California, United States, 92780
      • Robin K. Dore MD, Inc
    • Upland, California, United States, 91786
      • Inland Rheumatology & Osteoporosis Medical Group
    • Van Nuys, California, United States, 91405
      • Medvin Clinical Research - Weidmann
    • Whittier, California, United States, 90602
      • Medvin Clinical Research - Whittier
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Rheumatology Associates of South Florida
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Plantation, Florida, United States, 33324
      • IRIS Research and Development, LLC
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Arthritis & Rheumatology of Georgia
    • Gainesville, Georgia, United States, 30501
      • Arthritis Center of North Georgia
  • Idaho
    • Boise, Idaho, United States, 83702
      • St. Luke's Intermountain Research Center
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Alliance for Multispecialty Research, LLC
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Center for Arthritis and Osteoporosis
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Accurate Clinical Research
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research
  • Michigan
    • Brighton, Michigan, United States, 48116
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49546
      • West Michigan Rheumatology
    • Okemos, Michigan, United States, 48864
      • Advanced Rheumatology, PC
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
    • Omaha, Nebraska, United States, 68114
      • Westroads Clinical Research, Inc.
  • Nevada
    • Reno, Nevada, United States, 89519
      • Allied Clinical Research
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
    • Santa Fe, New Mexico, United States, 87505
      • Santa Fe Rheumatology
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Accellacare - Charlotte
    • Durham, North Carolina, United States, 27704
      • M3-Emerging Medical Research, LLC
    • Hickory, North Carolina, United States, 28602
      • Piedmont Rheumatology, P.A.
    • Leland, North Carolina, United States, 28451
      • Cape Fear Arthritis Care
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Rheumatic Disease Study Group
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research & Consulting, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • East Penn Rheumatology Associates
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading,LLC
    • Wyomissing, Pennsylvania, United States, 19610
      • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Regional Health Clinical Research
  • Texas
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Management
    • College Station, Texas, United States, 77845
      • Arthritis & Osteoporosis Clinic of Brazos Valley
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research
    • Houston, Texas, United States, 77084
      • Accurate Clinical Management - Houston
    • Houston, Texas, United States, 77089
      • Research Physicians Network, LLC
    • League City, Texas, United States, 77573
      • Accurate Clinical Research
    • San Antonio, Texas, United States, 78229
      • Accurate Clinical Research, Inc.
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • Sugar Land, Texas, United States, 77479
      • Accurate Clinical Management
    • Tomball, Texas, United States, 77375
      • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Tomball, Texas, United States, 77377
      • DM Clinical Research/Rheumatology Clinic of Houston
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 drugs (DMARD) (synthetic or biologic).

Exclusion Criteria:

• Participant should have no reason to not take a TNF inhibitor.
• Participants must not be pregnant or breastfeeding.
• Participants must not have had more than one VTE.
• 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 had a live vaccine within four weeks of study start.
• Participants must not have participated in any other clinical trial within four weeks of study start.
• Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib High Dose; Baricitinib administered orally.	Drug: Baricitinib; Administered orally.; Other Names: LY3009104
Experimental: Baricitinib Low Dose; Baricitinib administered orally.	Drug: Baricitinib; Administered orally.; Other Names: LY3009104
Active Comparator: TNF Inhibitor; Adalimumab or etanercept administered subcutaneously (SC) per standard of care.	Drug: TNF Inhibitor; Administered SC; Other Names: Etanercept; Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)	Time from First Dose of Study Treatment to First Event of VTE	Baseline through Study Completion (Approximately 5.5 Years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)	Time from First Dose of Study Treatment to First ATE	Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)	Time from First Dose of Study Treatment to First MACE	Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])	Time from First Dose of Study Treatment to First Malignancy (excluding NMSC)	Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Opportunistic Infection	Time from First Dose of Study Treatment to First Opportunistic Infection	Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Serious Infection	Time from First Dose of Study Treatment to First Serious Infection	Baseline through Study Completion (Approximately 5.5 Years)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Incyte Corporation
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Etanercept; Adalimumab; Tumor Necrosis Factor Inhibitors
• Other Study ID Numbers: 17172; I4V-MC-JAJA (Other Identifier: Eli Lilly and Company); 2018-003351-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No