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En undersøgelse af baricitinib (LY3009104) hos deltagere med reumatoid arthritis (RA-BRIDGE)

27. maj 2026 opdateret af: Eli Lilly and Company

En randomiseret, aktiv-kontrolleret, parallel-gruppe, fase 3b/4 undersøgelse af baricitinib hos patienter med reumatoid arthritis

Dette post-marketing studie er designet til at sammenligne sikkerheden af ​​baricitinib versus tumornekrosefaktor (TNF) hæmmere med hensyn til venøse tromboemboliske hændelser (VTE'er), når de gives til deltagere med reumatoid arthritis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2659

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Wolverhampton, Det Forenede Kongerige, WV10 0QP
        • New Cross Hospital
    • Bournemouth
      • Christchurch, Bournemouth, Det Forenede Kongerige, BH23 2JX
        • Christchurch Hospital
    • Devon
      • Plymouth, Devon, Det Forenede Kongerige, Pl6 8DH
        • Derriford Hospital
      • Torquay, Devon, Det Forenede Kongerige, TQ2 7AA
        • Torbay Hospital
    • England
      • Dudley, England, Det Forenede Kongerige, DY1 2HQ
        • The Dudley Group NHS Foundation Trust
      • London, England, Det Forenede Kongerige, NW32QG
        • Royal Free London NHS Foundation Trust
      • Truro, England, Det Forenede Kongerige, TR1 3LJ
        • The Royal Cornwall Hospital
    • Essex
      • Chelmsford, Essex, Det Forenede Kongerige, CM1 7ET
        • Mid Essex Hospital Services NHS Trust
    • Hampshire
      • Portsmouth, Hampshire, Det Forenede Kongerige, PO6 3LY
        • Queen Alexandra Hospital
    • Kingston Upon Hull
      • Hull, Kingston Upon Hull, Det Forenede Kongerige, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust
    • North Tyneside
      • Newcastle upon Tyne, North Tyneside, Det Forenede Kongerige, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
    • Nottinghamshire
      • Sutton in Ashfield, Nottinghamshire, Det Forenede Kongerige, NG17 4JL
        • King's Mill Hospital
    • Waltham Forest
      • London, Waltham Forest, Det Forenede Kongerige, E11 1NR
        • Barts Health NHS Trust - Whipps Cross University Hospital
  • Forenede Stater
    • Arizona
      • Flagstaff, Arizona, Forenede Stater, 86001
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Gilbert, Arizona, Forenede Stater, 85234
        • Arthrocare, Arthritiscare & Research PC
      • Glendale, Arizona, Forenede Stater, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, Forenede Stater, 85210
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Peoria, Arizona, Forenede Stater, 85381
        • HOPE Research Institute
      • Phoenix, Arizona, Forenede Stater, 85018
        • HOPE Research Institute
      • Tucson, Arizona, Forenede Stater, 85704
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • Covina, California, Forenede Stater, 91722
        • Medvin Clinical Research - Covina
      • Fullerton, California, Forenede Stater, 92835
        • St Joseph Heritage Healthcare
      • Huntington Beach, California, Forenede Stater, 92648
        • Christine Thai, MD
      • Irvine, California, Forenede Stater, 92604
        • Private Practice - Dr. Christine J. Leehealey
      • Rancho Mirage, California, Forenede Stater, 92270
        • Desert Medical Advances
      • San Diego, California, Forenede Stater, 92128
        • Rheumatology Center of San Diego
      • San Leandro, California, Forenede Stater, 94578
        • East Bay Rheumatology Medical Group, Inc
      • Tujunga, California, Forenede Stater, 91042
        • Dan La, MD Inc
      • Tustin, California, Forenede Stater, 92780
        • Robin K. Dore MD, Inc
      • Upland, California, Forenede Stater, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • Van Nuys, California, Forenede Stater, 91405
        • Medvin Clinical Research - Weidmann
      • Whittier, California, Forenede Stater, 90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Rheumatology Associates of South Florida
      • Miami, Florida, Forenede Stater, 33165
        • New Horizon Research Center
      • Miami, Florida, Forenede Stater, 33135
        • Suncoast Research Group
      • New Port Richey, Florida, Forenede Stater, 34652
        • Suncoast Clinical Research, Inc.
      • Plantation, Florida, Forenede Stater, 33324
        • IRIS Research and Development, LLC
      • South Miami, Florida, Forenede Stater, 33143
        • Qps-Mra, Llc
      • Tampa, Florida, Forenede Stater, 33613
        • ForCare Clinical Research
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville, Georgia, Forenede Stater, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Forenede Stater, 83702
        • St. Luke's Intermountain Research Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60640
        • Great Lakes Clinical Trials
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47715
        • Qualmedica Research, LLC
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Elizabethtown, Kentucky, Forenede Stater, 42701
        • Center For Arthritis and Osteoporosis
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70605
        • Accurate Clinical Research
    • Maryland
      • Wheaton, Maryland, Forenede Stater, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Fall River, Massachusetts, Forenede Stater, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Brighton, Michigan, Forenede Stater, 48116
        • University of Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • West Michigan Rheumatology
      • Okemos, Michigan, Forenede Stater, 48864
        • Advanced Rheumatology, PC
    • Missouri
      • City of Saint Peters, Missouri, Forenede Stater, 63303
        • StudyMetrix Research
      • Springfield, Missouri, Forenede Stater, 65807
        • Clinvest Research LLC
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier View Research Institute
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Physician Research Collaboration, LLC
      • Omaha, Nebraska, Forenede Stater, 68114
        • Westroads Clinical Research, Inc.
    • Nevada
      • Reno, Nevada, Forenede Stater, 89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Albuquerque Clinical Trials, Inc.
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Albuquerque Center For Rheumatology
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • Santa Fe Rheumatology
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28211
        • Accellacare - Charlotte
      • Durham, North Carolina, Forenede Stater, 27704
        • M3-Emerging Medical Research, LLC
      • Hickory, North Carolina, Forenede Stater, 28602
        • Piedmont Rheumatology, P.A.
      • Leland, North Carolina, Forenede Stater, 28451
        • Cape Fear Arthritis Care
      • Salisbury, North Carolina, Forenede Stater, 28144
        • PMG Research of Salisbury
      • Wilmington, North Carolina, Forenede Stater, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Cincinnati Rheumatic Disease Study Group
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Clinical Research Center of Reading,LLC
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Regional Health Clinical Research
    • Texas
      • Baytown, Texas, Forenede Stater, 77521
        • Accurate Clinical Management
      • College Station, Texas, Forenede Stater, 77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Houston, Texas, Forenede Stater, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Forenede Stater, 77089
        • Accurate Clinical Research
      • Houston, Texas, Forenede Stater, 77084
        • Accurate Clinical Management - Houston
      • Houston, Texas, Forenede Stater, 77089
        • Research Physicians Network, LLC
      • League City, Texas, Forenede Stater, 77573
        • Accurate Clinical Research
      • San Antonio, Texas, Forenede Stater, 78229
        • Accurate Clinical Research, Inc.
      • San Antonio, Texas, Forenede Stater, 78229
        • Clinical Trials of Texas, Inc.
      • Sugar Land, Texas, Forenede Stater, 77479
        • Accurate Clinical Management
      • Tomball, Texas, Forenede Stater, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
      • Tomball, Texas, Forenede Stater, 77377
        • DM Clinical Research/Rheumatology Clinic of Houston
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
        • Arthritis Northwest, PLLC
      • Vancouver, Washington, Forenede Stater, 98664
        • The Vancouver Clinic
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • CAMC Health Education and Research Institute Inc
  • Frankrig
      • Caluire-et-Cuire, Frankrig, 69300
        • Infirmerie Protestante de Lyon
      • Lille, Frankrig, 59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
      • Paris, Frankrig, 75013
        • Pitie Salpetriere University Hospital
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankrig, 06000
        • Chu De Nice
    • Alsace
      • Strasbourg, Alsace, Frankrig, 67098
        • CHU Strasbourg-Hautepierre
    • Aquitaine
      • Bordeaux, Aquitaine, Frankrig, 33076
        • Bordeaux University Hospital - Pellegrin
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrig, 69003
        • Hôpital Edouard Herriot
    • Centre-Val de Loire
      • Orléans, Centre-Val de Loire, Frankrig, 45067
        • Centre Hospitalier Régional d'Orléans
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrig, 31059
        • Hôpital Pierre-Paul Riquet
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Frankrig, 44093
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrig, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
    • Vendée
      • La Roche-sur-Yon, Vendée, Frankrig, 85000
        • CHD Vendée
  • Grækenland
    • Attikí
      • Chaïdári, Attikí, Grækenland, 12462
        • Attikon General University Hospital
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Grækenland, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Évros
      • Alexandroupoli, Évros, Grækenland, 68100
        • University Hospital of Alexandroupolis
  • Holland
    • Limburg
      • Born, Limburg, Holland, 6121 XK
        • PT&R / PreCare Trial & Recruitment
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Holland, 8934 AD
        • Medische Centrum Leeuwarden
  • 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
  • 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
  • Rumænien
      • Brăila, Rumænien, 810019
        • CMI Cristei Dorica
    • Brașov County
      • Brasov, Brașov County, Rumænien, 500283
        • C.M.D.T.A. Neomed
    • Bucharest
      • Bucharest, Bucharest, Rumænien, 011172
        • Spital Clinic Sf. Maria
      • Bucharest, Bucharest, Rumænien, 014142
        • Delta Health Care
      • Bucharest, Bucharest, Rumænien, 30463
        • CCBR Clinical Research
    • Galați County
      • Galati, Galați County, Rumænien, 800578
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
    • Iaşi
      • Iași, Iaşi, Rumænien, 707027
        • RK Medcenter
    • Maramureş
      • Baia Mare, Maramureş, Rumænien, 430031
        • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Rumænien, 240762
        • SC Medaudio-Optica SRL
  • Rusland
      • Petrozavodsk, Rusland, 185019
        • Karelia Republican Hospital V.A. Baranova
      • Saratov, Rusland, 410053
        • Regional Clinical Hospital of the Saratov Region
      • Yaroslavl, Rusland, 150003
        • Research & Practice
    • Kursk Oblast
      • Kursk, Kursk Oblast, Rusland, 305007
        • Kursk Regional Clinical Hospital
    • Leningradskaya Oblast'
      • Saint-Petersburg, Leningradskaya Oblast', Rusland, 194291
        • Gbuz Lokb
    • Moscow
      • Moscow, Moscow, Rusland, 111123
        • Moscow Clinical Research Center
      • Moscow, Moscow, Rusland, 115522
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Moscow, Rusland, 129110
        • M. F. Vladimirskiy Moscow Regional Research Clinical Institute
    • Moscow Oblast
      • Moscow, Moscow Oblast, Rusland, 119991
        • First Moscow State Medical University I.M. Sechenov
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rusland, 603005
        • Nizhny Novgorod City Clinical Hospital Number 5
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Rusland, 390026
        • Ryazan Regional Clinical Cardiological Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rusland, 191015
        • North-Western State Medical University named after I.I.Mechnikov
      • Saint Petersburg, Sankt-Peterburg, Rusland, 190068
        • Clinical Rheumatology hospital #25
    • Tula Oblast
      • Tula, Tula Oblast, Rusland, 300053
        • Tula Regional Clinical Hospital
    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Rusland, 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
  • Slovakiet
    • Banská Bystrica Region
      • Zvolen, Banská Bystrica Region, Slovakiet, 960 01
        • Albamed s.r.o.
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakiet, 851 01
        • Romjan s.r.o.
    • Košice Region
      • Košice, Košice Region, Slovakiet, 040 11
        • Artromac n.o.
      • Spišská Nová Ves, Košice Region, Slovakiet, 05201
        • Reumed s.r.o.
    • Nitra Region
      • Topoľčany, Nitra Region, Slovakiet, 955 01
        • LERAM s.r.o.
    • Trenčín Region
      • Partizánske, Trenčín Region, Slovakiet, 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
  • 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
  • Tjekkiet
      • Prague, Tjekkiet, 14000
        • Revmatologicka ambulance
      • Prague, Tjekkiet, 14800
        • Affidea Praha, s.r.o.
    • Brno-město
      • Brno, Brno-město, Tjekkiet, 63800
        • Revmatologie.s.r.o.
      • Brno, Brno-město, Tjekkiet, 61500
        • Revmacentrum MUDr. Mostera, s.r.o.
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tjekkiet, 722 00
        • Artroscan, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Tjekkiet, 70300
        • INREA s.r.o.
    • Pardubice Region
      • Pardubice, Pardubice Region, Tjekkiet, 53002
        • Arthrohelp S.R.O.
    • Praha 10
      • Prague, Praha 10, Tjekkiet, 100 00
        • CLINTRIAL s.r.o.
    • Praha 4
      • Prague, Praha 4, Tjekkiet, 140 00
        • Revmatologie MUDr. Štejfová
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Tjekkiet, 12850
        • Revmatologicky Ustav
    • South Moravian
      • Brno, South Moravian, Tjekkiet, 61141
        • REVMACLINIC s.r.o.
    • Zlín
      • Uherské Hradiště, Zlín, Tjekkiet, 686 01
        • Medical Plus
      • Zlín, Zlín, Tjekkiet, 760 01
        • PV Medical Services s.r.o.
  • Tyrkiet (Türkiye)
      • Edirne, Tyrkiet (Türkiye), 22030
        • Trakya University
      • Istanbul, Tyrkiet (Türkiye), 34098
        • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
      • Izmir, Tyrkiet (Türkiye), 35620
        • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
      • Konya, Tyrkiet (Türkiye)
        • Necmettin Erbakan Meram Medical Fac.
    • Eskişehir
      • Eskişehir, Eskişehir, Tyrkiet (Türkiye), 26480
        • Eskisehir Osmangazi University
    • Istanbul
      • Stanbul, Istanbul, Tyrkiet (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
  • Ungarn
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Ungarn, 4031
        • Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Ungarn, 3529
        • CRU Hungary Kft.
    • Pest County
      • Budapest, Pest County, Ungarn, 1027
        • Revita Clinic
      • Budapest, Pest County, Ungarn, 1033
        • Clinexpert Kft.
    • Veszprém City
      • Veszprém, Veszprém City, Ungarn, 8200
        • Vital Medical Center
  • Østrig
      • Vienna, Østrig, 1100
        • Rheuma-Zentrum Oberlaa GmbH
    • State of Vienna
      • Vienna, State of Vienna, Østrig, 1090
        • Medizinische Universität Wien
      • Vienna, State of Vienna, Østrig, 1160
        • Wilhelminenspital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltagere skal have mindst én af følgende egenskaber:

    • Dokumenteret bevis for en VTE før denne undersøgelse
    • Mindst 60 år
    • Et kropsmasseindeks (BMI) større end eller lig med 30 kilogram pr. kvadratmetre (kg/m²), eller
    • Alder 50 til under 60 år og BMI 25 til under 30 kg/m².
  • Deltagerne skal have en utilstrækkelig respons eller intolerance over for mindst 1 sygdomsmodificerende antirheumatisk medicin (DMARD) (syntetisk eller biologisk).

Ekskluderingskriterier:

  • Deltageren bør ikke have nogen grund til ikke at tage en TNF-hæmmer.
  • Deltagerne må ikke være gravide eller ammende.
  • Deltagerne må ikke have haft mere end én VTE.
  • Deltagerne må ikke have kræft.
  • Deltagerne må ikke have aktiv herpes zoster, alvorlig infektion, aktiv tuberkulose eller nogen anden alvorlig sygdom.
  • Deltagerne må ikke have fået en levende vaccine inden for fire uger efter studiestart.
  • Deltagerne må ikke have deltaget i andre kliniske forsøg inden for fire uger efter studiestart.
  • Deltagerne må ikke have en historie med intravenøs stofbrug, andet ulovligt stofmisbrug eller kronisk alkoholmisbrug i det seneste år.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Baricitinib
Indgives oralt.
Andre navne:
  • LY3009104
Eksperimentel: 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.
Medicin: Baricitinib
Indgives oralt.
Andre navne:
  • 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.
Medicin: TNF Inhibitor
Administered subcutaneously.
Andre navne:
  • Etanercept
  • Adalimumab

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Samarbejdspartnere

Incyte Corporation

Efterforskere

  • Studieleder: 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 og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. april 2019

Primær færdiggørelse (Faktiske)

28. maj 2025

Studieafslutning (Faktiske)

28. maj 2025

Datoer for studieregistrering

Først indsendt

12. april 2019

Først indsendt, der opfyldte QC-kriterier

12. april 2019

Først opslået (Faktiske)

16. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner