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

May 27, 2026 updated by: Eli Lilly and Company

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2659

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Vienna, Austria, 1100
        • Rheuma-Zentrum Oberlaa GmbH
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Medizinische Universität Wien
      • Vienna, State of Vienna, Austria, 1160
        • Wilhelminenspital
  • Belgium
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1070
        • Université Libre de Bruxelles - Hôpital Erasme
    • Flanders
      • Merksem, Flanders, Belgium, 2170
        • ZNA Jan Palfijn
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Reuma Clinic, Locatie Jaarbeurslaan
  • Czechia
      • Prague, Czechia, 14000
        • Revmatologicka ambulance
      • Prague, Czechia, 14800
        • Affidea Praha, s.r.o.
    • Brno-město
      • Brno, Brno-město, Czechia, 63800
        • Revmatologie.s.r.o.
      • Brno, Brno-město, Czechia, 61500
        • Revmacentrum MUDr. Mostera, s.r.o.
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 722 00
        • Artroscan, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Czechia, 70300
        • INREA s.r.o.
    • Pardubice Region
      • Pardubice, Pardubice Region, Czechia, 53002
        • Arthrohelp S.R.O.
    • Praha 10
      • Prague, Praha 10, Czechia, 100 00
        • CLINTRIAL s.r.o.
    • Praha 4
      • Prague, Praha 4, Czechia, 140 00
        • Revmatologie MUDr. Štejfová
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Czechia, 12850
        • Revmatologicky Ustav
    • South Moravian
      • Brno, South Moravian, Czechia, 61141
        • REVMACLINIC s.r.o.
    • Zlín
      • Uherské Hradiště, Zlín, Czechia, 686 01
        • Medical Plus
      • Zlín, Zlín, Czechia, 760 01
        • PV Medical Services s.r.o.
  • Denmark
    • Central Jutland
      • Silkeborg, Central Jutland, Denmark, 8600
        • Regionshospitalet Silkeborg
    • Region Syddanmark
      • Svendborg, Region 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 Régional Universitaire de Lille - Hôpital 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
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Hôpital Edouard Herriot
    • Centre-Val de Loire
      • Orléans, Centre-Val de Loire, 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
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
    • 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
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
    • Mecklenburg-Vorpommern
      • Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
        • Rheumazentrum Prof.Neeck MVZ
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln
      • Ratingen, North Rhine-Westphalia, Germany, 40878
        • Rheumazentrum Ratingen Studienambulanz
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39110
        • Institut für Präventive Medizin & Klinische Forschung GbR
  • Greece
    • Attikí
      • Chaïdári, Attikí, Greece, 12462
        • Attikon General University Hospital
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Greece, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Évros
      • Alexandroupoli, 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-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3529
        • CRU Hungary Kft.
    • Pest County
      • Budapest, Pest County, Hungary, 1027
        • Revita Clinic
      • Budapest, Pest County, Hungary, 1033
        • Clinexpert Kft.
    • Veszprém City
      • Veszprém, Veszprém City, Hungary, 8200
        • Vital Medical Center
  • Israel
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center
      • Ramat Gan, Central District, Israel, 5262100
        • Sheba Medical Center
    • Southern District
      • Ashkelon, Southern District, Israel, 7830604
        • Barzilai 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
      • Florence, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Naples, 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
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Ospedale Le Scotte
  • Lithuania
      • Vilnius, Lithuania, 01117
        • Centro poliklinika
    • Kauno Miestas
      • Kaunas, Kauno Miestas, Lithuania, 45130
        • Republican Hospital of Kaunas
    • Šiauliai County
      • Šiauliai, Šiauliai County, Lithuania, 76231
        • Respublikin Šiauli ligonin
  • Netherlands
    • Limburg
      • Born, Limburg, Netherlands, 6121 XK
        • PT&R / PreCare Trial & Recruitment
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
        • Medische Centrum Leeuwarden
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-113
        • Ai Centrum Medyczne Sp. Z O.O.
      • Poznan, Greater Poland Voivodeship, Poland, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • MICS Centrum Medyczne Torun
    • Lublin Voivodeship
      • Tomaszów Lubelski, Lublin Voivodeship, Poland, 22-600
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
    • Masovian Voivodeship
      • Nadarzyn, Masovian Voivodeship, Poland, 05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • ETG Warszawa
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Centrum Medyczne Reuma Park
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • Medycyna Kliniczna
      • Warsaw, Masovian Voivodeship, Poland, 02-118
        • Rheuma Medicus- Zaklad Opieki Zdrowotnej
      • Warsaw, Masovian Voivodeship, Poland, 03-291
        • Centrum Medyczne AMED Warszawa Targówek
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Osteo Medic sc A. Racewicz, J. Supronik
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Poland, 41-902
        • BIF-MED
      • Katowice, Silesian Voivodeship, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Ustroń, Silesian Voivodeship, Poland, 43-450
        • Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Ambulatorium Barbara Bazela
  • 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
      • Brăila, Romania, 810019
        • CMI Cristei Dorica
    • Brașov County
      • Brasov, Brașov County, Romania, 500283
        • C.M.D.T.A. Neomed
    • Bucharest
      • Bucharest, Bucharest, Romania, 011172
        • Spital Clinic Sf. Maria
      • Bucharest, Bucharest, Romania, 014142
        • Delta Health Care
      • Bucharest, Bucharest, Romania, 30463
        • CCBR Clinical Research
    • Galați County
      • Galati, Galați County, Romania, 800578
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
    • Iaşi
      • Iași, Iaşi, Romania, 707027
        • RK Medcenter
    • Maramureş
      • Baia Mare, Maramureş, Romania, 430031
        • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romania, 240762
        • Sc Medaudio-Optica Srl
  • Russia
      • Petrozavodsk, Russia, 185019
        • Karelia Republican Hospital V.A. Baranova
      • Saratov, Russia, 410053
        • Regional Clinical Hospital of the Saratov Region
      • Yaroslavl, Russia, 150003
        • Research & Practice
    • Kursk Oblast
      • Kursk, Kursk Oblast, Russia, 305007
        • Kursk Regional Clinical Hospital
    • Leningradskaya Oblast'
      • Saint-Petersburg, Leningradskaya Oblast', Russia, 194291
        • Gbuz Lokb
    • Moscow
      • Moscow, Moscow, Russia, 111123
        • Moscow Clinical Research Center
      • Moscow, Moscow, Russia, 115522
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Moscow, Russia, 129110
        • M. F. Vladimirskiy Moscow Regional Research Clinical Institute
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 119991
        • First Moscow State Medical University I.M. Sechenov
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603005
        • Nizhny Novgorod City Clinical Hospital Number 5
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russia, 390026
        • Ryazan Regional Clinical Cardiological Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 191015
        • North-Western State Medical University named after I.I.Mechnikov
      • Saint Petersburg, Sankt-Peterburg, Russia, 190068
        • Clinical Rheumatology hospital #25
    • Tula Oblast
      • Tula, Tula Oblast, Russia, 300053
        • Tula Regional Clinical Hospital
    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Russia, 432063
        • GUZ UOKB
  • Slovakia
    • Banská Bystrica Region
      • Zvolen, Banská Bystrica Region, Slovakia, 960 01
        • Albamed s.r.o.
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 851 01
        • Romjan s.r.o.
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 11
        • Artromac n.o.
      • Spišská Nová Ves, Košice Region, Slovakia, 05201
        • Reumed s.r.o.
    • Nitra Region
      • Topoľčany, Nitra Region, Slovakia, 955 01
        • LERAM s.r.o.
    • Trenčín Region
      • Partizánske, Trenčín Region, 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
      • Córdoba, Spain, 14004
        • HU Reina Sofia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41010
        • Hospital Quiron Infanta Luisa
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
        • Clinica Gaias - Santiago
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Hospital General Universitario de Elche
      • Villajoyosa, Alicante, Spain, 03570
        • Hospital Marina Baixa
    • Basque Country
      • Bilbao, Basque Country, Spain, 48013
        • Osi Bilbao-Basurto
    • 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 Quirón 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
    • 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
    • Pontevedra [Pontevedra]
      • Vigo, Pontevedra [Pontevedra], Spain, 36200
        • CHUVI- Hospital do Meixoeiro
  • Switzerland
      • Fribourg, Switzerland, 1708
        • HFR Fribourg - Hôpital Cantonal
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4056
        • University Hospital Basel
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen
  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
      • Izmir, Turkey (Türkiye), 35620
        • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
      • Konya, Turkey (Türkiye)
        • Necmettin Erbakan Meram Medical Fac.
    • Eskişehir
      • Eskişehir, Eskişehir, Turkey (Türkiye), 26480
        • Eskisehir Osmangazi University
    • Istanbul
      • Stanbul, Istanbul, Turkey (Türkiye), 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
      • City of 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 drug (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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baricitinib 2mg
Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2mg could receive rescue treatment with baricitinib 4mg.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104
Experimental: Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104
Active Comparator: Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Drug: TNF Inhibitor
Administered subcutaneously.
Other Names:
  • Etanercept
  • Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Time Frame: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Time Frame: From the date of first dose of study drug up to the last dose (approximately up to 6.1 years)

Duration of exposure was calculated as:

  • Baricitinib 2mg exposure = date of last baricitinib 2mg treatment - date of first baricitinib 2mg dose + 1. For participants who were rescued from baricitinib 2 mg to 4 mg, their drug exposure after rescue was censored and not counted as exposure to baricitinib 2mg.
  • Baricitinib 4mg exposure = date of last baricitinib 4mg treatment - date of first baricitinib 4mg dose + 1.
  • TNF inhibitor exposure = date of last TNFi (adalimumab or etanercept) - date of first TNFi dose (adalimumab or etanercept) + 1, regardless of treatment cycling from adalimumab to etanercept or vice versa.
  • Total baricitinib exposure (2/4 mg) = date of last baricitinib (2mg or 4mg) treatment - date of first baricitinib (2mg or 4mg) dose + 1, regardless of rescue from baricitinib 2mg to baricitinib 4mg.

Patient-years is calculated as sum of duration of exposure in days for all patients in dosing regimen divided by 365.25.
From the date of first dose of study drug up to the last dose (approximately up to 6.1 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

June 24, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17172
  • I4V-MC-JAJA (Other Identifier: Eli Lilly and Company)
  • 2018-003351-37 (EudraCT Number)
  • 2023-508022-10-00 (Ctis)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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