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Um estudo de baricitinibe (LY3009104) em participantes com artrite reumatoide (RA-BRIDGE)

27 de maio de 2026 atualizado por: Eli Lilly and Company

Um Estudo Randomizado, Ativo-Controlado, Grupo Paralelo, Fase 3b/4 de Baricitinibe em Pacientes com Artrite Reumatoide

Este estudo pós-comercialização foi desenvolvido para comparar a segurança de baricitinibe versus inibidores do fator de necrose tumoral (TNF) em relação a eventos tromboembólicos venosos (TEVs) quando administrados a participantes com artrite reumatoide.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

2659

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 14059
        • Schlosspark Klinik
      • Berlin, Alemanha, 12163
        • Praxis für Rheumatologie und Innere
      • Hamburg, Alemanha, 22391
        • Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz
      • Hamburg, Alemanha, 20095
        • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
    • Hesse
      • Frankfurt am Main, Hesse, Alemanha, 60590
        • CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
    • Mecklenburg-Vorpommern
      • Bad Doberan, Mecklenburg-Vorpommern, Alemanha, 18209
        • Rheumazentrum Prof.Neeck MVZ
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Alemanha, 50937
        • Universitaetsklinikum Koeln
      • Ratingen, North Rhine-Westphalia, Alemanha, 40878
        • Rheumazentrum Ratingen Studienambulanz
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Alemanha, 39110
        • Institut für Präventive Medizin & Klinische Forschung GbR
  • Austrália
    • New South Wales
      • Botany, New South Wales, Austrália, 2019
        • Optimus Clinical Research
      • Newcastle, New South Wales, Austrália, 2292
        • Genesis Research Services
    • Queensland
      • Maroochydore, Queensland, Austrália, 4558
        • Rheumatology Research Unit
    • Tasmania
      • Hobart, Tasmania, Austrália, 7000
        • Southern Clinical Research
    • Victoria
      • Camberwell, Victoria, Austrália, 3124
        • Emeritus Research
  • Bélgica
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Bélgica, 1070
        • Université Libre de Bruxelles - Hôpital Erasme
    • Flanders
      • Merksem, Flanders, Bélgica, 2170
        • ZNA Jan Palfijn
    • Limburg
      • Genk, Limburg, Bélgica, 3600
        • Reuma Clinic, Locatie Jaarbeurslaan
  • Dinamarca
    • Central Jutland
      • Silkeborg, Central Jutland, Dinamarca, 8600
        • Regionshospitalet Silkeborg
    • Region Syddanmark
      • Svendborg, Region Syddanmark, Dinamarca, 5700
        • Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital
  • Eslováquia
    • Banská Bystrica Region
      • Zvolen, Banská Bystrica Region, Eslováquia, 960 01
        • Albamed s.r.o.
    • Bratislava Region
      • Bratislava, Bratislava Region, Eslováquia, 851 01
        • Romjan s.r.o.
    • Košice Region
      • Košice, Košice Region, Eslováquia, 040 11
        • Artromac n.o.
      • Spišská Nová Ves, Košice Region, Eslováquia, 05201
        • Reumed s.r.o.
    • Nitra Region
      • Topoľčany, Nitra Region, Eslováquia, 955 01
        • LERAM s.r.o.
    • Trenčín Region
      • Partizánske, Trenčín Region, Eslováquia, 958 01
        • Reumacentrum s.r.o.
  • Espanha
      • Córdoba, Espanha, 14004
        • Hospital Quirónsalud Córdoba
      • Córdoba, Espanha, 14004
        • HU Reina Sofia
      • Madrid, Espanha, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Espanha, 28046
        • Hospital Universitario La Paz
      • Seville, Espanha, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Espanha, 41010
        • Hospital Quiron Infanta Luisa
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Espanha, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, A Coruña [La Coruña], Espanha, 15702
        • Clínica Gaias - Santiago
    • Alicante
      • Elche, Alicante, Espanha, 03202
        • Hospital General Universitario de Elche
      • Villajoyosa, Alicante, Espanha, 03570
        • Hospital Marina Baixa
    • Basque Country
      • Bilbao, Basque Country, Espanha, 48013
        • Osi Bilbao-Basurto
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Espanha, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Catalunya [Cataluña], Espanha, 08022
        • Clinica Sagrada Familia
      • Barcelona, Catalunya [Cataluña], Espanha, 08023
        • Hospital Quirón Barcelona
      • Sabadell, Catalunya [Cataluña], Espanha, 08208
        • Corporacio Sanitaria Parc Tauli
      • Sant Joan Despí, Catalunya [Cataluña], Espanha, 08970
        • Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
    • Galicia [Galicia]
      • Santiago de Compostela, Galicia [Galicia], Espanha, 15706
        • CHUS - Hospital Clinico Universitario
    • Madrid, Comunidad de
      • Fuenlabrada, Madrid, Comunidad de, Espanha, 28944
        • Hospital Universitario de Fuenlabrada
      • Getafe, Madrid, Comunidad de, Espanha, 28905
        • Hospital Universitario Getafe
      • Majadahonda, Madrid, Comunidad de, Espanha, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Pontevedra [Pontevedra]
      • Vigo, Pontevedra [Pontevedra], Espanha, 36200
        • CHUVI- Hospital do Meixoeiro
  • Estados Unidos
    • Arizona
      • Flagstaff, Arizona, Estados Unidos, 86001
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Gilbert, Arizona, Estados Unidos, 85234
        • Arthrocare, Arthritiscare & Research PC
      • Glendale, Arizona, Estados Unidos, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, Estados Unidos, 85210
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Peoria, Arizona, Estados Unidos, 85381
        • HOPE Research Institute
      • Phoenix, Arizona, Estados Unidos, 85018
        • HOPE Research Institute
      • Tucson, Arizona, Estados Unidos, 85704
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • Covina, California, Estados Unidos, 91722
        • Medvin Clinical Research - Covina
      • Fullerton, California, Estados Unidos, 92835
        • St Joseph Heritage Healthcare
      • Huntington Beach, California, Estados Unidos, 92648
        • Christine Thai, MD
      • Irvine, California, Estados Unidos, 92604
        • Private Practice - Dr. Christine J. Leehealey
      • Rancho Mirage, California, Estados Unidos, 92270
        • Desert Medical Advances
      • San Diego, California, Estados Unidos, 92128
        • Rheumatology Center of San Diego
      • San Leandro, California, Estados Unidos, 94578
        • East Bay Rheumatology Medical Group, Inc
      • Tujunga, California, Estados Unidos, 91042
        • Dan La, MD Inc
      • Tustin, California, Estados Unidos, 92780
        • Robin K. Dore MD, Inc
      • Upland, California, Estados Unidos, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • Van Nuys, California, Estados Unidos, 91405
        • Medvin Clinical Research - Weidmann
      • Whittier, California, Estados Unidos, 90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Stamford, Connecticut, Estados Unidos, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Rheumatology Associates of South Florida
      • Miami, Florida, Estados Unidos, 33165
        • New Horizon Research Center
      • Miami, Florida, Estados Unidos, 33135
        • Suncoast Research Group
      • New Port Richey, Florida, Estados Unidos, 34652
        • Suncoast Clinical Research, Inc.
      • Plantation, Florida, Estados Unidos, 33324
        • IRIS Research and Development, LLC
      • South Miami, Florida, Estados Unidos, 33143
        • Qps-Mra, Llc
      • Tampa, Florida, Estados Unidos, 33613
        • ForCare Clinical Research
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville, Georgia, Estados Unidos, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • St. Luke's Intermountain Research Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60640
        • Great Lakes Clinical Trials
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47715
        • Qualmedica Research, LLC
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Elizabethtown, Kentucky, Estados Unidos, 42701
        • Center For Arthritis and Osteoporosis
    • Louisiana
      • Lake Charles, Louisiana, Estados Unidos, 70605
        • Accurate Clinical Research
    • Maryland
      • Wheaton, Maryland, Estados Unidos, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Fall River, Massachusetts, Estados Unidos, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Brighton, Michigan, Estados Unidos, 48116
        • University of Michigan
      • Grand Rapids, Michigan, Estados Unidos, 49546
        • West Michigan Rheumatology
      • Okemos, Michigan, Estados Unidos, 48864
        • Advanced Rheumatology, PC
    • Missouri
      • City of Saint Peters, Missouri, Estados Unidos, 63303
        • StudyMetrix Research
      • Springfield, Missouri, Estados Unidos, 65807
        • Clinvest Research LLC
    • Montana
      • Kalispell, Montana, Estados Unidos, 59901
        • Glacier View Research Institute
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68516
        • Physician Research Collaboration, LLC
      • Omaha, Nebraska, Estados Unidos, 68114
        • Westroads Clinical Research, Inc.
    • Nevada
      • Reno, Nevada, Estados Unidos, 89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87102
        • Albuquerque Clinical Trials, Inc.
      • Albuquerque, New Mexico, Estados Unidos, 87102
        • Albuquerque Center For Rheumatology
      • Santa Fe, New Mexico, Estados Unidos, 87505
        • Santa Fe Rheumatology
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28211
        • Accellacare - Charlotte
      • Durham, North Carolina, Estados Unidos, 27704
        • M3-Emerging Medical Research, LLC
      • Hickory, North Carolina, Estados Unidos, 28602
        • Piedmont Rheumatology, P.A.
      • Leland, North Carolina, Estados Unidos, 28451
        • Cape Fear Arthritis Care
      • Salisbury, North Carolina, Estados Unidos, 28144
        • PMG Research of Salisbury
      • Wilmington, North Carolina, Estados Unidos, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45242
        • Cincinnati Rheumatic Disease Study Group
      • Marietta, Ohio, Estados Unidos, 45750
        • Marietta Memorial Hospital
      • Middleburg Heights, Ohio, Estados Unidos, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Estados Unidos, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, Estados Unidos, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Estados Unidos, 19610
        • Clinical Research Center of Reading,LLC
      • Wyomissing, Pennsylvania, Estados Unidos, 19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Regional Health Clinical Research
    • Texas
      • Baytown, Texas, Estados Unidos, 77521
        • Accurate Clinical Management
      • College Station, Texas, Estados Unidos, 77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Houston, Texas, Estados Unidos, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Estados Unidos, 77089
        • Accurate Clinical Research
      • Houston, Texas, Estados Unidos, 77084
        • Accurate Clinical Management - Houston
      • Houston, Texas, Estados Unidos, 77089
        • Research Physicians Network, LLC
      • League City, Texas, Estados Unidos, 77573
        • Accurate Clinical Research
      • San Antonio, Texas, Estados Unidos, 78229
        • Accurate Clinical Research, Inc.
      • San Antonio, Texas, Estados Unidos, 78229
        • Clinical Trials of Texas, Inc.
      • Sugar Land, Texas, Estados Unidos, 77479
        • Accurate Clinical Management
      • Tomball, Texas, Estados Unidos, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
      • Tomball, Texas, Estados Unidos, 77377
        • DM Clinical Research/Rheumatology Clinic of Houston
    • Washington
      • Spokane, Washington, Estados Unidos, 99204
        • Arthritis Northwest, PLLC
      • Vancouver, Washington, Estados Unidos, 98664
        • The Vancouver Clinic
    • West Virginia
      • Charleston, West Virginia, Estados Unidos, 25304
        • CAMC Health Education and Research Institute Inc
  • França
      • Caluire-et-Cuire, França, 69300
        • Infirmerie Protestante de Lyon
      • Lille, França, 59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
      • Paris, França, 75013
        • Pitie Salpetriere University Hospital
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, França, 06000
        • Chu De Nice
    • Alsace
      • Strasbourg, Alsace, França, 67098
        • CHU Strasbourg-Hautepierre
    • Aquitaine
      • Bordeaux, Aquitaine, França, 33076
        • Bordeaux University Hospital - Pellegrin
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, França, 69003
        • Hôpital Edouard Herriot
    • Centre-Val de Loire
      • Orléans, Centre-Val de Loire, França, 45067
        • Centre Hospitalier Régional d'Orléans
    • Haute-Garonne
      • Toulouse, Haute-Garonne, França, 31059
        • Hôpital Pierre-Paul Riquet
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, França, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, França, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
    • Vendée
      • La Roche-sur-Yon, Vendée, França, 85000
        • CHD Vendée
  • Grécia
    • Attikí
      • Chaïdári, Attikí, Grécia, 12462
        • Attikon General University Hospital
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Grécia, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Évros
      • Alexandroupoli, Évros, Grécia, 68100
        • University Hospital of Alexandroupolis
  • Holanda
    • Limburg
      • Born, Limburg, Holanda, 6121 XK
        • PT&R / PreCare Trial & Recruitment
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Holanda, 8934 AD
        • Medische Centrum Leeuwarden
  • Hungria
      • Debrecen, Hungria, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungria, 4031
        • Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungria, 3529
        • CRU Hungary Kft.
    • Pest County
      • Budapest, Pest County, Hungria, 1027
        • Revita Clinic
      • Budapest, Pest County, Hungria, 1033
        • Clinexpert Kft.
    • Veszprém City
      • Veszprém, Veszprém City, Hungria, 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
  • Itália
      • Florence, Itália, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Naples, Itália, 80131
        • University of Campania Luigi Vanvitelli
      • Verona, Itália, 37100
        • Policlinico GB Rossi Borgo Roma
    • Abruzzo
      • Chieti, Abruzzo, Itália, 66013
        • Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
    • Milano
      • Milan, Milano, Itália, 20157
        • Ospedale Luigi Sacco
    • Tuscany
      • Siena, Tuscany, Itália, 53100
        • Ospedale Le Scotte
  • Lituânia
      • Vilnius, Lituânia, 01117
        • Centro poliklinika
    • Kauno Miestas
      • Kaunas, Kauno Miestas, Lituânia, 45130
        • Republican Hospital of Kaunas
    • Šiauliai County
      • Šiauliai, Šiauliai County, Lituânia, 76231
        • Respublikin Šiauli ligonin
  • Polônia
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polônia, 61-113
        • Ai Centrum Medyczne Sp. Z O.O.
      • Poznan, Greater Poland Voivodeship, Polônia, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polônia, 85-168
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
      • Torun, Kuyavian-Pomeranian Voivodeship, Polônia, 87-100
        • MICS Centrum Medyczne Toruń
    • Lublin Voivodeship
      • Tomaszów Lubelski, Lublin Voivodeship, Polônia, 22-600
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polônia, 67-100
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
    • Masovian Voivodeship
      • Nadarzyn, Masovian Voivodeship, Polônia, 05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Warsaw, Masovian Voivodeship, Polônia, 02-677
        • ETG Warszawa
      • Warsaw, Masovian Voivodeship, Polônia, 02-665
        • Centrum Medyczne Reuma Park
      • Warsaw, Masovian Voivodeship, Polônia, 00-874
        • Medycyna Kliniczna
      • Warsaw, Masovian Voivodeship, Polônia, 02-118
        • Rheuma Medicus- Zaklad Opieki Zdrowotnej
      • Warsaw, Masovian Voivodeship, Polônia, 03-291
        • Centrum Medyczne AMED Warszawa Targówek
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polônia, 15-351
        • Osteo Medic sc A. Racewicz, J. Supronik
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polônia, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Polônia, 41-902
        • BIF-MED
      • Katowice, Silesian Voivodeship, Polônia, 40-081
        • Centrum Medyczne Pratia Katowice
      • Ustroń, Silesian Voivodeship, Polônia, 43-450
        • Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Polônia, 82-300
        • Ambulatorium Barbara Bazela
  • Porto Rico
      • Caguas, Porto Rico, 00725
        • Centro Reumatologico Caguas
      • Ponce, Porto Rico, 00716
        • Ponce Medical School Foundation Inc.
      • San Juan, Porto Rico, 00918
        • Mindful Medical Research
      • San Juan, Porto Rico, 00909
        • Latin Clinical Trial Center
      • San Juan, Porto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • Reino Unido
      • Liverpool, Reino Unido, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Wolverhampton, Reino Unido, WV10 0QP
        • New Cross Hospital
    • Bournemouth
      • Christchurch, Bournemouth, Reino Unido, BH23 2JX
        • Christchurch Hospital
    • Devon
      • Plymouth, Devon, Reino Unido, Pl6 8DH
        • Derriford Hospital
      • Torquay, Devon, Reino Unido, TQ2 7AA
        • Torbay Hospital
    • England
      • Dudley, England, Reino Unido, DY1 2HQ
        • The Dudley Group NHS Foundation Trust
      • London, England, Reino Unido, NW32QG
        • Royal Free London NHS Foundation Trust
      • Truro, England, Reino Unido, TR1 3LJ
        • The Royal Cornwall Hospital
    • Essex
      • Chelmsford, Essex, Reino Unido, CM1 7ET
        • Mid Essex Hospital Services NHS Trust
    • Hampshire
      • Portsmouth, Hampshire, Reino Unido, PO6 3LY
        • Queen Alexandra Hospital
    • Kingston Upon Hull
      • Hull, Kingston Upon Hull, Reino Unido, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust
    • North Tyneside
      • Newcastle upon Tyne, North Tyneside, Reino Unido, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
    • Nottinghamshire
      • Sutton in Ashfield, Nottinghamshire, Reino Unido, NG17 4JL
        • King's Mill Hospital
    • Waltham Forest
      • London, Waltham Forest, Reino Unido, E11 1NR
        • Barts Health NHS Trust - Whipps Cross University Hospital
  • Romênia
      • Brăila, Romênia, 810019
        • CMI Cristei Dorica
    • Brașov County
      • Brasov, Brașov County, Romênia, 500283
        • C.M.D.T.A. Neomed
    • Bucharest
      • Bucharest, Bucharest, Romênia, 011172
        • Spital Clinic Sf. Maria
      • Bucharest, Bucharest, Romênia, 014142
        • Delta Health Care
      • Bucharest, Bucharest, Romênia, 30463
        • CCBR Clinical Research
    • Galați County
      • Galati, Galați County, Romênia, 800578
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
    • Iaşi
      • Iași, Iaşi, Romênia, 707027
        • RK Medcenter
    • Maramureş
      • Baia Mare, Maramureş, Romênia, 430031
        • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romênia, 240762
        • SC Medaudio-Optica SRL
  • Rússia
      • Petrozavodsk, Rússia, 185019
        • Karelia Republican Hospital V.A. Baranova
      • Saratov, Rússia, 410053
        • Regional Clinical Hospital of the Saratov Region
      • Yaroslavl, Rússia, 150003
        • Research & Practice
    • Kursk Oblast
      • Kursk, Kursk Oblast, Rússia, 305007
        • Kursk Regional Clinical Hospital
    • Leningradskaya Oblast'
      • Saint-Petersburg, Leningradskaya Oblast', Rússia, 194291
        • Gbuz Lokb
    • Moscow
      • Moscow, Moscow, Rússia, 111123
        • Moscow Clinical Research Center
      • Moscow, Moscow, Rússia, 115522
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Moscow, Rússia, 129110
        • M. F. Vladimirskiy Moscow Regional Research Clinical Institute
    • Moscow Oblast
      • Moscow, Moscow Oblast, Rússia, 119991
        • First Moscow State Medical University I.M. Sechenov
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rússia, 603005
        • Nizhny Novgorod City Clinical Hospital Number 5
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Rússia, 390026
        • Ryazan Regional Clinical Cardiological Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rússia, 191015
        • North-Western State Medical University named after I.I.Mechnikov
      • Saint Petersburg, Sankt-Peterburg, Rússia, 190068
        • Clinical Rheumatology hospital #25
    • Tula Oblast
      • Tula, Tula Oblast, Rússia, 300053
        • Tula Regional Clinical Hospital
    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Rússia, 432063
        • GUZ UOKB
  • Suíça
      • Fribourg, Suíça, 1708
        • HFR Fribourg - Hôpital Cantonal
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Suíça, 4056
        • University Hospital Basel
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Suíça, 9007
        • Cantonal Hospital St.Gallen
  • Tcheca
      • Prague, Tcheca, 14000
        • Revmatologicka ambulance
      • Prague, Tcheca, 14800
        • Affidea Praha, s.r.o.
    • Brno-město
      • Brno, Brno-město, Tcheca, 63800
        • Revmatologie.s.r.o.
      • Brno, Brno-město, Tcheca, 61500
        • Revmacentrum MUDr. Mostera, s.r.o.
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tcheca, 722 00
        • Artroscan, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Tcheca, 70300
        • INREA s.r.o.
    • Pardubice Region
      • Pardubice, Pardubice Region, Tcheca, 53002
        • Arthrohelp S.R.O.
    • Praha 10
      • Prague, Praha 10, Tcheca, 100 00
        • CLINTRIAL s.r.o.
    • Praha 4
      • Prague, Praha 4, Tcheca, 140 00
        • Revmatologie MUDr. Štejfová
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Tcheca, 12850
        • Revmatologicky Ustav
    • South Moravian
      • Brno, South Moravian, Tcheca, 61141
        • REVMACLINIC s.r.o.
    • Zlín
      • Uherské Hradiště, Zlín, Tcheca, 686 01
        • Medical Plus
      • Zlín, Zlín, Tcheca, 760 01
        • PV Medical Services s.r.o.
  • Turquia (Türkiye)
      • Edirne, Turquia (Türkiye), 22030
        • Trakya University
      • Istanbul, Turquia (Türkiye), 34098
        • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
      • Izmir, Turquia (Türkiye), 35620
        • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
      • Konya, Turquia (Türkiye)
        • Necmettin Erbakan Meram Medical Fac.
    • Eskişehir
      • Eskişehir, Eskişehir, Turquia (Türkiye), 26480
        • Eskisehir Osmangazi University
    • Istanbul
      • Stanbul, Istanbul, Turquia (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
  • África do Sul
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, África do Sul, 6045
        • Netcare Greenacres Hospital
    • Free State
      • Bloemfontein, Free State, África do Sul, 9301
        • Iatros International
      • Bloemfontein, Free State, África do Sul, 9301
        • FARMOVS
    • Gauteng
      • Kempton Park, Gauteng, África do Sul, 1619
        • Clinresco Centres
      • Pretoria, Gauteng, África do Sul, 0001
        • University of Pretoria - Faculty of Health Sciences
    • KwaZulu-Natal
      • Chatsworth, KwaZulu-Natal, África do Sul, 4092
        • Precise Clinical Solutions
      • Umhlanga, KwaZulu-Natal, África do Sul, 4320
        • Netcare Umhlanga Hospital
    • Western Cape
      • Cape Town, Western Cape, África do Sul, 7405
        • Arthritis Clinical Trial Centre
      • Stellenbosch, Western Cape, África do Sul, 7600
        • Winelands Medical Research Centre
  • Áustria
      • Vienna, Áustria, 1100
        • Rheuma-Zentrum Oberlaa GmbH
    • State of Vienna
      • Vienna, State of Vienna, Áustria, 1090
        • Medizinische Universität Wien
      • Vienna, State of Vienna, Áustria, 1160
        • Wilhelminenspital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Os participantes devem ter pelo menos uma das seguintes características:

    • Evidência documentada de TEV antes deste estudo
    • Pelo menos 60 anos de idade
    • Um índice de massa corporal (IMC) maior ou igual a 30 quilos por metro quadrado (kg/m²), ou
    • Idade de 50 a menos de 60 anos e IMC de 25 a menos de 30 kg/m².
  • Os participantes devem ter uma resposta inadequada ou intolerância a pelo menos 1 medicamento antirreumático modificador da doença (DMARD) (sintético ou biológico).

Critério de exclusão:

  • O participante não deve ter motivos para não tomar um inibidor de TNF.
  • As participantes não devem estar grávidas ou amamentando.
  • Os participantes não devem ter tido mais de um TEV.
  • Os participantes não devem ter câncer.
  • Os participantes não devem ter herpes zoster ativo, infecção grave, tuberculose ativa ou qualquer outra doença grave.
  • Os participantes não devem ter recebido uma vacina viva dentro de quatro semanas após o início do estudo.
  • Os participantes não devem ter participado de nenhum outro ensaio clínico dentro de quatro semanas após o início do estudo.
  • Os participantes não devem ter histórico de uso de drogas intravenosas, abuso de outras drogas ilícitas ou abuso crônico de álcool no último ano.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Baricitinibe
Administrado por via oral.
Outros nomes:
  • 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.
Medicamento: Baricitinibe
Administrado por via oral.
Outros nomes:
  • LY3009104
Comparador Ativo: 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.
Medicamento: TNF Inhibitor
Administered subcutaneously.
Outros nomes:
  • Etanercepte
  • Adalimumabe

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eli Lilly and Company

Colaboradores

Incyte Corporation

Investigadores

  • Diretor de estudo: 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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de abril de 2019

Conclusão Primária (Real)

28 de maio de 2025

Conclusão do estudo (Real)

28 de maio de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

12 de abril de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de abril de 2019

Primeira postagem (Real)

16 de abril de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 17172
  • I4V-MC-JAJA (Outro identificador: Eli Lilly and Company)
  • 2018-003351-37 (Número EudraCT)
  • 2023-508022-10-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Os dados anônimos individuais do nível do paciente serão fornecidos em um ambiente de acesso seguro após a aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.

Prazo de Compartilhamento de IPD

Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na UE, o que ocorrer mais tarde. Os dados ficarão indefinidamente disponíveis para solicitação.

Critérios de acesso de compartilhamento IPD

Uma proposta de pesquisa deve ser aprovada por um painel de revisão independente e os pesquisadores devem assinar um acordo de compartilhamento de dados.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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