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En studie av baricitinib (LY3009104) hos deltagare med reumatoid artrit (RA-BRIDGE)

27 maj 2026 uppdaterad av: Eli Lilly and Company

En randomiserad, aktivt kontrollerad, parallellgruppsstudie i fas 3b/4 av baricitinib hos patienter med reumatoid artrit

Denna post-marketing studie är utformad för att jämföra säkerheten för baricitinib kontra tumörnekrosfaktor (TNF)-hämmare med avseende på venösa tromboemboliska händelser (VTE) när de ges till deltagare med reumatoid artrit.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

2659

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • New South Wales
      • Botany, New South Wales, Australien, 2019
        • Optimus Clinical Research
      • Newcastle, New South Wales, Australien, 2292
        • Genesis Research Services
    • Queensland
      • Maroochydore, Queensland, Australien, 4558
        • Rheumatology Research Unit
    • Tasmania
      • Hobart, Tasmania, Australien, 7000
        • Southern Clinical Research
    • Victoria
      • Camberwell, Victoria, Australien, 3124
        • Emeritus Research
  • Belgien
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgien, 1070
        • Université Libre de Bruxelles - Hôpital Erasme
    • Flanders
      • Merksem, Flanders, Belgien, 2170
        • ZNA Jan Palfijn
    • Limburg
      • Genk, Limburg, Belgien, 3600
        • Reuma Clinic, Locatie Jaarbeurslaan
  • Danmark
    • Central Jutland
      • Silkeborg, Central Jutland, Danmark, 8600
        • Regionshospitalet Silkeborg
    • Region Syddanmark
      • Svendborg, Region Syddanmark, Danmark, 5700
        • Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital
  • Frankrike
      • Caluire-et-Cuire, Frankrike, 69300
        • Infirmerie Protestante de Lyon
      • Lille, Frankrike, 59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
      • Paris, Frankrike, 75013
        • Pitie Salpetriere University Hospital
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankrike, 06000
        • Chu De Nice
    • Alsace
      • Strasbourg, Alsace, Frankrike, 67098
        • CHU Strasbourg-Hautepierre
    • Aquitaine
      • Bordeaux, Aquitaine, Frankrike, 33076
        • Bordeaux University Hospital - Pellegrin
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrike, 69003
        • Hôpital Edouard Herriot
    • Centre-Val de Loire
      • Orléans, Centre-Val de Loire, Frankrike, 45067
        • Centre Hospitalier Régional d'Orléans
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrike, 31059
        • Hôpital Pierre-Paul Riquet
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Frankrike, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrike, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
    • Vendée
      • La Roche-sur-Yon, Vendée, Frankrike, 85000
        • CHD Vendée
  • Förenta staterna
    • Arizona
      • Flagstaff, Arizona, Förenta staterna, 86001
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Gilbert, Arizona, Förenta staterna, 85234
        • Arthrocare, Arthritiscare & Research PC
      • Glendale, Arizona, Förenta staterna, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, Förenta staterna, 85210
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Peoria, Arizona, Förenta staterna, 85381
        • HOPE Research Institute
      • Phoenix, Arizona, Förenta staterna, 85018
        • HOPE Research Institute
      • Tucson, Arizona, Förenta staterna, 85704
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • Covina, California, Förenta staterna, 91722
        • Medvin Clinical Research - Covina
      • Fullerton, California, Förenta staterna, 92835
        • St Joseph Heritage Healthcare
      • Huntington Beach, California, Förenta staterna, 92648
        • Christine Thai, MD
      • Irvine, California, Förenta staterna, 92604
        • Private Practice - Dr. Christine J. Leehealey
      • Rancho Mirage, California, Förenta staterna, 92270
        • Desert Medical Advances
      • San Diego, California, Förenta staterna, 92128
        • Rheumatology Center of San Diego
      • San Leandro, California, Förenta staterna, 94578
        • East Bay Rheumatology Medical Group, Inc
      • Tujunga, California, Förenta staterna, 91042
        • Dan La, MD Inc
      • Tustin, California, Förenta staterna, 92780
        • Robin K. Dore MD, Inc
      • Upland, California, Förenta staterna, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • Van Nuys, California, Förenta staterna, 91405
        • Medvin Clinical Research - Weidmann
      • Whittier, California, Förenta staterna, 90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Stamford, Connecticut, Förenta staterna, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Boca Raton, Florida, Förenta staterna, 33486
        • Rheumatology Associates of South Florida
      • Miami, Florida, Förenta staterna, 33165
        • New Horizon Research Center
      • Miami, Florida, Förenta staterna, 33135
        • Suncoast Research Group
      • New Port Richey, Florida, Förenta staterna, 34652
        • Suncoast Clinical Research, Inc.
      • Plantation, Florida, Förenta staterna, 33324
        • IRIS Research and Development, LLC
      • South Miami, Florida, Förenta staterna, 33143
        • Qps-Mra, Llc
      • Tampa, Florida, Förenta staterna, 33613
        • ForCare Clinical Research
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville, Georgia, Förenta staterna, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Förenta staterna, 83702
        • St. Luke's Intermountain Research Center
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60640
        • Great Lakes Clinical Trials
    • Indiana
      • Evansville, Indiana, Förenta staterna, 47715
        • Qualmedica Research, LLC
    • Kansas
      • Wichita, Kansas, Förenta staterna, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Elizabethtown, Kentucky, Förenta staterna, 42701
        • Center For Arthritis and Osteoporosis
    • Louisiana
      • Lake Charles, Louisiana, Förenta staterna, 70605
        • Accurate Clinical Research
    • Maryland
      • Wheaton, Maryland, Förenta staterna, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Fall River, Massachusetts, Förenta staterna, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Brighton, Michigan, Förenta staterna, 48116
        • University of Michigan
      • Grand Rapids, Michigan, Förenta staterna, 49546
        • West Michigan Rheumatology
      • Okemos, Michigan, Förenta staterna, 48864
        • Advanced Rheumatology, PC
    • Missouri
      • City of Saint Peters, Missouri, Förenta staterna, 63303
        • StudyMetrix Research
      • Springfield, Missouri, Förenta staterna, 65807
        • Clinvest Research LLC
    • Montana
      • Kalispell, Montana, Förenta staterna, 59901
        • Glacier View Research Institute
    • Nebraska
      • Lincoln, Nebraska, Förenta staterna, 68516
        • Physician Research Collaboration, LLC
      • Omaha, Nebraska, Förenta staterna, 68114
        • Westroads Clinical Research, Inc.
    • Nevada
      • Reno, Nevada, Förenta staterna, 89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87102
        • Albuquerque Clinical Trials, Inc.
      • Albuquerque, New Mexico, Förenta staterna, 87102
        • Albuquerque Center For Rheumatology
      • Santa Fe, New Mexico, Förenta staterna, 87505
        • Santa Fe Rheumatology
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28211
        • Accellacare - Charlotte
      • Durham, North Carolina, Förenta staterna, 27704
        • M3-Emerging Medical Research, LLC
      • Hickory, North Carolina, Förenta staterna, 28602
        • Piedmont Rheumatology, P.A.
      • Leland, North Carolina, Förenta staterna, 28451
        • Cape Fear Arthritis Care
      • Salisbury, North Carolina, Förenta staterna, 28144
        • PMG Research of Salisbury
      • Wilmington, North Carolina, Förenta staterna, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45242
        • Cincinnati Rheumatic Disease Study Group
      • Marietta, Ohio, Förenta staterna, 45750
        • Marietta Memorial Hospital
      • Middleburg Heights, Ohio, Förenta staterna, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Förenta staterna, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Bethlehem, Pennsylvania, Förenta staterna, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, Förenta staterna, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Förenta staterna, 19610
        • Clinical Research Center of Reading,LLC
      • Wyomissing, Pennsylvania, Förenta staterna, 19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Dakota
      • Rapid City, South Dakota, Förenta staterna, 57701
        • Regional Health Clinical Research
    • Texas
      • Baytown, Texas, Förenta staterna, 77521
        • Accurate Clinical Management
      • College Station, Texas, Förenta staterna, 77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Houston, Texas, Förenta staterna, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Förenta staterna, 77089
        • Accurate Clinical Research
      • Houston, Texas, Förenta staterna, 77084
        • Accurate Clinical Management - Houston
      • Houston, Texas, Förenta staterna, 77089
        • Research Physicians Network, LLC
      • League City, Texas, Förenta staterna, 77573
        • Accurate Clinical Research
      • San Antonio, Texas, Förenta staterna, 78229
        • Accurate Clinical Research, Inc.
      • San Antonio, Texas, Förenta staterna, 78229
        • Clinical Trials of Texas, Inc.
      • Sugar Land, Texas, Förenta staterna, 77479
        • Accurate Clinical Management
      • Tomball, Texas, Förenta staterna, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
      • Tomball, Texas, Förenta staterna, 77377
        • DM Clinical Research/Rheumatology Clinic of Houston
    • Washington
      • Spokane, Washington, Förenta staterna, 99204
        • Arthritis Northwest, PLLC
      • Vancouver, Washington, Förenta staterna, 98664
        • The Vancouver Clinic
    • West Virginia
      • Charleston, West Virginia, Förenta staterna, 25304
        • CAMC Health Education and Research Institute Inc
  • Grekland
    • Attikí
      • Chaïdári, Attikí, Grekland, 12462
        • Attikon General University Hospital
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Grekland, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Évros
      • Alexandroupoli, Évros, Grekland, 68100
        • University Hospital of Alexandroupolis
  • 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
  • Italien
      • Florence, Italien, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Naples, Italien, 80131
        • University of Campania Luigi Vanvitelli
      • Verona, Italien, 37100
        • Policlinico GB Rossi Borgo Roma
    • Abruzzo
      • Chieti, Abruzzo, Italien, 66013
        • Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
    • Milano
      • Milan, Milano, Italien, 20157
        • Ospedale Luigi Sacco
    • Tuscany
      • Siena, Tuscany, Italien, 53100
        • Ospedale Le Scotte
  • Litauen
      • Vilnius, Litauen, 01117
        • Centro poliklinika
    • Kauno Miestas
      • Kaunas, Kauno Miestas, Litauen, 45130
        • Republican Hospital of Kaunas
    • Šiauliai County
      • Šiauliai, Šiauliai County, Litauen, 76231
        • Respublikin Šiauli ligonin
  • Nederländerna
    • Limburg
      • Born, Limburg, Nederländerna, 6121 XK
        • PT&R / PreCare Trial & Recruitment
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Nederländerna, 8934 AD
        • Medische Centrum Leeuwarden
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 61-113
        • Ai Centrum Medyczne Sp. Z O.O.
      • Poznan, Greater Poland Voivodeship, Polen, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-168
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
      • Torun, Kuyavian-Pomeranian Voivodeship, Polen, 87-100
        • MICS Centrum Medyczne Toruń
    • Lublin Voivodeship
      • Tomaszów Lubelski, Lublin Voivodeship, Polen, 22-600
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polen, 67-100
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
    • Masovian Voivodeship
      • Nadarzyn, Masovian Voivodeship, Polen, 05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Warsaw, Masovian Voivodeship, Polen, 02-677
        • ETG Warszawa
      • Warsaw, Masovian Voivodeship, Polen, 02-665
        • Centrum Medyczne Reuma Park
      • Warsaw, Masovian Voivodeship, Polen, 00-874
        • Medycyna Kliniczna
      • Warsaw, Masovian Voivodeship, Polen, 02-118
        • Rheuma Medicus- Zaklad Opieki Zdrowotnej
      • Warsaw, Masovian Voivodeship, Polen, 03-291
        • Centrum Medyczne AMED Warszawa Targówek
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-351
        • Osteo Medic sc A. Racewicz, J. Supronik
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Polen, 41-902
        • BIF-MED
      • Katowice, Silesian Voivodeship, Polen, 40-081
        • Centrum Medyczne Pratia Katowice
      • Ustroń, Silesian Voivodeship, Polen, 43-450
        • Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Polen, 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
  • Rumänien
      • Brăila, Rumänien, 810019
        • CMI Cristei Dorica
    • Brașov County
      • Brasov, Brașov County, Rumänien, 500283
        • C.M.D.T.A. Neomed
    • Bucharest
      • Bucharest, Bucharest, Rumänien, 011172
        • Spital Clinic Sf. Maria
      • Bucharest, Bucharest, Rumänien, 014142
        • Delta Health Care
      • Bucharest, Bucharest, Rumänien, 30463
        • CCBR Clinical Research
    • Galați County
      • Galati, Galați County, Rumänien, 800578
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
    • Iaşi
      • Iași, Iaşi, Rumänien, 707027
        • RK Medcenter
    • Maramureş
      • Baia Mare, Maramureş, Rumänien, 430031
        • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Rumänien, 240762
        • SC Medaudio-Optica SRL
  • Ryssland
      • Petrozavodsk, Ryssland, 185019
        • Karelia Republican Hospital V.A. Baranova
      • Saratov, Ryssland, 410053
        • Regional Clinical Hospital of the Saratov Region
      • Yaroslavl, Ryssland, 150003
        • Research & Practice
    • Kursk Oblast
      • Kursk, Kursk Oblast, Ryssland, 305007
        • Kursk Regional Clinical Hospital
    • Leningradskaya Oblast'
      • Saint-Petersburg, Leningradskaya Oblast', Ryssland, 194291
        • Gbuz Lokb
    • Moscow
      • Moscow, Moscow, Ryssland, 111123
        • Moscow Clinical Research Center
      • Moscow, Moscow, Ryssland, 115522
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Moscow, Ryssland, 129110
        • M. F. Vladimirskiy Moscow Regional Research Clinical Institute
    • Moscow Oblast
      • Moscow, Moscow Oblast, Ryssland, 119991
        • First Moscow State Medical University I.M. Sechenov
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Ryssland, 603005
        • Nizhny Novgorod City Clinical Hospital Number 5
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Ryssland, 390026
        • Ryazan Regional Clinical Cardiological Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Ryssland, 191015
        • North-Western State Medical University named after I.I.Mechnikov
      • Saint Petersburg, Sankt-Peterburg, Ryssland, 190068
        • Clinical Rheumatology hospital #25
    • Tula Oblast
      • Tula, Tula Oblast, Ryssland, 300053
        • Tula Regional Clinical Hospital
    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Ryssland, 432063
        • GUZ UOKB
  • Schweiz
      • Fribourg, Schweiz, 1708
        • HFR Fribourg - Hôpital Cantonal
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Schweiz, 4056
        • University Hospital Basel
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Schweiz, 9007
        • Cantonal Hospital St.Gallen
  • Slovakien
    • Banská Bystrica Region
      • Zvolen, Banská Bystrica Region, Slovakien, 960 01
        • Albamed s.r.o.
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakien, 851 01
        • Romjan s.r.o.
    • Košice Region
      • Košice, Košice Region, Slovakien, 040 11
        • Artromac n.o.
      • Spišská Nová Ves, Košice Region, Slovakien, 05201
        • Reumed s.r.o.
    • Nitra Region
      • Topoľčany, Nitra Region, Slovakien, 955 01
        • LERAM s.r.o.
    • Trenčín Region
      • Partizánske, Trenčín Region, Slovakien, 958 01
        • Reumacentrum s.r.o.
  • Spanien
      • Córdoba, Spanien, 14004
        • Hospital Quirónsalud Córdoba
      • Córdoba, Spanien, 14004
        • HU Reina Sofia
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Seville, Spanien, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spanien, 41010
        • Hospital Quiron Infanta Luisa
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spanien, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, A Coruña [La Coruña], Spanien, 15702
        • Clínica Gaias - Santiago
    • Alicante
      • Elche, Alicante, Spanien, 03202
        • Hospital General Universitario de Elche
      • Villajoyosa, Alicante, Spanien, 03570
        • Hospital Marina Baixa
    • Basque Country
      • Bilbao, Basque Country, Spanien, 48013
        • Osi Bilbao-Basurto
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spanien, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Catalunya [Cataluña], Spanien, 08022
        • Clinica Sagrada Familia
      • Barcelona, Catalunya [Cataluña], Spanien, 08023
        • Hospital Quirón Barcelona
      • Sabadell, Catalunya [Cataluña], Spanien, 08208
        • Corporacio Sanitaria Parc Tauli
      • Sant Joan Despí, Catalunya [Cataluña], Spanien, 08970
        • Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
    • Galicia [Galicia]
      • Santiago de Compostela, Galicia [Galicia], Spanien, 15706
        • CHUS - Hospital Clinico Universitario
    • Madrid, Comunidad de
      • Fuenlabrada, Madrid, Comunidad de, Spanien, 28944
        • Hospital Universitario de Fuenlabrada
      • Getafe, Madrid, Comunidad de, Spanien, 28905
        • Hospital Universitario Getafe
      • Majadahonda, Madrid, Comunidad de, Spanien, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Pontevedra [Pontevedra]
      • Vigo, Pontevedra [Pontevedra], Spanien, 36200
        • CHUVI- Hospital do Meixoeiro
  • Storbritannien
      • Liverpool, Storbritannien, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Wolverhampton, Storbritannien, WV10 0QP
        • New Cross Hospital
    • Bournemouth
      • Christchurch, Bournemouth, Storbritannien, BH23 2JX
        • Christchurch Hospital
    • Devon
      • Plymouth, Devon, Storbritannien, Pl6 8DH
        • Derriford Hospital
      • Torquay, Devon, Storbritannien, TQ2 7AA
        • Torbay Hospital
    • England
      • Dudley, England, Storbritannien, DY1 2HQ
        • The Dudley Group NHS Foundation Trust
      • London, England, Storbritannien, NW32QG
        • Royal Free London NHS Foundation Trust
      • Truro, England, Storbritannien, TR1 3LJ
        • The Royal Cornwall Hospital
    • Essex
      • Chelmsford, Essex, Storbritannien, CM1 7ET
        • Mid Essex Hospital Services NHS Trust
    • Hampshire
      • Portsmouth, Hampshire, Storbritannien, PO6 3LY
        • Queen Alexandra Hospital
    • Kingston Upon Hull
      • Hull, Kingston Upon Hull, Storbritannien, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust
    • North Tyneside
      • Newcastle upon Tyne, North Tyneside, Storbritannien, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
    • Nottinghamshire
      • Sutton in Ashfield, Nottinghamshire, Storbritannien, NG17 4JL
        • King's Mill Hospital
    • Waltham Forest
      • London, Waltham Forest, Storbritannien, E11 1NR
        • Barts Health NHS Trust - Whipps Cross University Hospital
  • Sydafrika
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, Sydafrika, 6045
        • Netcare Greenacres Hospital
    • Free State
      • Bloemfontein, Free State, Sydafrika, 9301
        • Iatros International
      • Bloemfontein, Free State, Sydafrika, 9301
        • FARMOVS
    • Gauteng
      • Kempton Park, Gauteng, Sydafrika, 1619
        • Clinresco Centres
      • Pretoria, Gauteng, Sydafrika, 0001
        • University of Pretoria - Faculty of Health Sciences
    • KwaZulu-Natal
      • Chatsworth, KwaZulu-Natal, Sydafrika, 4092
        • Precise Clinical Solutions
      • Umhlanga, KwaZulu-Natal, Sydafrika, 4320
        • Netcare Umhlanga Hospital
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7405
        • Arthritis Clinical Trial Centre
      • Stellenbosch, Western Cape, Sydafrika, 7600
        • Winelands Medical Research Centre
  • Tjeckien
      • Prague, Tjeckien, 14000
        • Revmatologicka ambulance
      • Prague, Tjeckien, 14800
        • Affidea Praha, s.r.o.
    • Brno-město
      • Brno, Brno-město, Tjeckien, 63800
        • Revmatologie.s.r.o.
      • Brno, Brno-město, Tjeckien, 61500
        • Revmacentrum MUDr. Mostera, s.r.o.
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tjeckien, 722 00
        • Artroscan, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Tjeckien, 70300
        • INREA s.r.o.
    • Pardubice Region
      • Pardubice, Pardubice Region, Tjeckien, 53002
        • Arthrohelp S.R.O.
    • Praha 10
      • Prague, Praha 10, Tjeckien, 100 00
        • CLINTRIAL s.r.o.
    • Praha 4
      • Prague, Praha 4, Tjeckien, 140 00
        • Revmatologie MUDr. Štejfová
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Tjeckien, 12850
        • Revmatologicky Ustav
    • South Moravian
      • Brno, South Moravian, Tjeckien, 61141
        • REVMACLINIC s.r.o.
    • Zlín
      • Uherské Hradiště, Zlín, Tjeckien, 686 01
        • Medical Plus
      • Zlín, Zlín, Tjeckien, 760 01
        • PV Medical Services s.r.o.
  • Turkiet (Türkiye)
      • Edirne, Turkiet (Türkiye), 22030
        • Trakya University
      • Istanbul, Turkiet (Türkiye), 34098
        • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
      • Izmir, Turkiet (Türkiye), 35620
        • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
      • Konya, Turkiet (Türkiye)
        • Necmettin Erbakan Meram Medical Fac.
    • Eskişehir
      • Eskişehir, Eskişehir, Turkiet (Türkiye), 26480
        • Eskisehir Osmangazi University
    • Istanbul
      • Stanbul, Istanbul, Turkiet (Türkiye), 34899
        • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
  • Tyskland
      • Berlin, Tyskland, 14059
        • Schlosspark Klinik
      • Berlin, Tyskland, 12163
        • Praxis für Rheumatologie und Innere
      • Hamburg, Tyskland, 22391
        • Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz
      • Hamburg, Tyskland, 20095
        • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60590
        • CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
    • Mecklenburg-Vorpommern
      • Bad Doberan, Mecklenburg-Vorpommern, Tyskland, 18209
        • Rheumazentrum Prof.Neeck MVZ
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Universitaetsklinikum Koeln
      • Ratingen, North Rhine-Westphalia, Tyskland, 40878
        • Rheumazentrum Ratingen Studienambulanz
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Tyskland, 39110
        • Institut für Präventive Medizin & Klinische Forschung GbR
  • Ungern
      • Debrecen, Ungern, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Ungern, 4031
        • Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Ungern, 3529
        • CRU Hungary Kft.
    • Pest County
      • Budapest, Pest County, Ungern, 1027
        • Revita Clinic
      • Budapest, Pest County, Ungern, 1033
        • Clinexpert Kft.
    • Veszprém City
      • Veszprém, Veszprém City, Ungern, 8200
        • Vital Medical Center
  • Österrike
      • Vienna, Österrike, 1100
        • Rheuma-Zentrum Oberlaa GmbH
    • State of Vienna
      • Vienna, State of Vienna, Österrike, 1090
        • Medizinische Universität Wien
      • Vienna, State of Vienna, Österrike, 1160
        • Wilhelminenspital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Deltagare måste ha minst en av följande egenskaper:

    • Dokumenterade bevis på en VTE före denna studie
    • Minst 60 år
    • Ett kroppsmassaindex (BMI) större än eller lika med 30 kilogram per kvadratmeter (kg/m²), eller
    • Ålder 50 till mindre än 60 år och BMI 25 till mindre än 30 kg/m².
  • Deltagarna måste ha ett otillräckligt svar eller intolerans mot minst 1 sjukdomsmodifierande antireumatiska läkemedel (DMARD) (syntetiska eller biologiska).

Exklusions kriterier:

  • Deltagaren ska inte ha någon anledning att inte ta en TNF-hämmare.
  • Deltagarna får inte vara gravida eller amma.
  • Deltagare får inte ha haft mer än en VTE.
  • Deltagare får inte ha cancer.
  • Deltagarna får inte ha aktiv herpes zoster, allvarlig infektion, aktiv tuberkulos eller någon annan allvarlig sjukdom.
  • Deltagarna får inte ha fått ett levande vaccin inom fyra veckor efter studiestart.
  • Deltagarna får inte ha deltagit i någon annan klinisk prövning inom fyra veckor efter studiestart.
  • Deltagarna får inte ha en historia av intravenöst droganvändning, annat olagligt drogmissbruk eller kroniskt alkoholmissbruk under det senaste året.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Baricitinib
Administreras oralt.
Andra namn:
  • LY3009104
Experimentell: 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.
Läkemedel: Baricitinib
Administreras oralt.
Andra namn:
  • LY3009104
Aktiv komparator: 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.
Läkemedel: TNF Inhibitor
Administered subcutaneously.
Andra namn:
  • Etanercept
  • Adalimumab

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eli Lilly and Company

Samarbetspartners

Incyte Corporation

Utredare

  • Studierektor: 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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 april 2019

Primärt slutförande (Faktisk)

28 maj 2025

Avslutad studie (Faktisk)

28 maj 2025

Studieregistreringsdatum

Först inskickad

12 april 2019

Först inskickad som uppfyllde QC-kriterierna

12 april 2019

Första postat (Faktisk)

16 april 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 17172
  • I4V-MC-JAJA (Annan identifierare: Eli Lilly and Company)
  • 2018-003351-37 (EudraCT-nummer)
  • 2023-508022-10-00 (Ctis)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Anonymiserad individuell patientnivådata kommer att tillhandahållas i en säker åtkomstmiljö efter godkännande av ett forskningsförslag och ett undertecknat datadelningsavtal.

Tidsram för IPD-delning

Data finns tillgängliga 6 månader efter den primära publiceringen och godkännandet av den studerade indikationen i USA och EU, beroende på vilket som inträffar senare. Data kommer att vara tillgängliga på obestämd tid för begäran.

Kriterier för IPD Sharing Access

Ett forskningsförslag måste godkännas av en oberoende granskningspanel och forskare måste underteckna ett datadelningsavtal.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera