Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie av baricitinib (LY3009104) hos deltakere med revmatoid artritt (RA-BRIDGE)

27. mai 2026 oppdatert av: Eli Lilly and Company

En randomisert, aktiv-kontrollert, parallellgruppe, fase 3b/4-studie av baricitinib hos pasienter med revmatoid artritt

Denne post-markedsføringsstudien er designet for å sammenligne sikkerheten til baricitinib versus tumornekrosefaktor (TNF)-hemmere med hensyn til venøse tromboemboliske hendelser (VTE) når de gis til deltakere med revmatoid artritt.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2659

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Optimus Clinical Research
      • Newcastle, New South Wales, Australia, 2292
        • Genesis Research Services
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Rheumatology Research Unit
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Southern Clinical Research
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
  • Belgia
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgia, 1070
        • Université Libre de Bruxelles - Hôpital Erasme
    • Flanders
      • Merksem, Flanders, Belgia, 2170
        • ZNA Jan Palfijn
    • Limburg
      • Genk, Limburg, Belgia, 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
  • Forente stater
    • Arizona
      • Flagstaff, Arizona, Forente stater, 86001
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Gilbert, Arizona, Forente stater, 85234
        • Arthrocare, Arthritiscare & Research PC
      • Glendale, Arizona, Forente stater, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, Forente stater, 85210
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Peoria, Arizona, Forente stater, 85381
        • HOPE Research Institute
      • Phoenix, Arizona, Forente stater, 85018
        • HOPE Research Institute
      • Tucson, Arizona, Forente stater, 85704
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • Covina, California, Forente stater, 91722
        • Medvin Clinical Research - Covina
      • Fullerton, California, Forente stater, 92835
        • St Joseph Heritage Healthcare
      • Huntington Beach, California, Forente stater, 92648
        • Christine Thai, MD
      • Irvine, California, Forente stater, 92604
        • Private Practice - Dr. Christine J. Leehealey
      • Rancho Mirage, California, Forente stater, 92270
        • Desert Medical Advances
      • San Diego, California, Forente stater, 92128
        • Rheumatology Center of San Diego
      • San Leandro, California, Forente stater, 94578
        • East Bay Rheumatology Medical Group, Inc
      • Tujunga, California, Forente stater, 91042
        • Dan La, MD Inc
      • Tustin, California, Forente stater, 92780
        • Robin K. Dore MD, Inc
      • Upland, California, Forente stater, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • Van Nuys, California, Forente stater, 91405
        • Medvin Clinical Research - Weidmann
      • Whittier, California, Forente stater, 90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Stamford, Connecticut, Forente stater, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Rheumatology Associates of South Florida
      • Miami, Florida, Forente stater, 33165
        • New Horizon Research Center
      • Miami, Florida, Forente stater, 33135
        • Suncoast Research Group
      • New Port Richey, Florida, Forente stater, 34652
        • Suncoast Clinical Research, Inc.
      • Plantation, Florida, Forente stater, 33324
        • IRIS Research and Development, LLC
      • South Miami, Florida, Forente stater, 33143
        • Qps-Mra, Llc
      • Tampa, Florida, Forente stater, 33613
        • ForCare Clinical Research
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville, Georgia, Forente stater, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Forente stater, 83702
        • St. Luke's Intermountain Research Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60640
        • Great Lakes Clinical Trials
    • Indiana
      • Evansville, Indiana, Forente stater, 47715
        • Qualmedica Research, LLC
    • Kansas
      • Wichita, Kansas, Forente stater, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Elizabethtown, Kentucky, Forente stater, 42701
        • Center For Arthritis and Osteoporosis
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70605
        • Accurate Clinical Research
    • Maryland
      • Wheaton, Maryland, Forente stater, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Brighton, Michigan, Forente stater, 48116
        • University of Michigan
      • Grand Rapids, Michigan, Forente stater, 49546
        • West Michigan Rheumatology
      • Okemos, Michigan, Forente stater, 48864
        • Advanced Rheumatology, PC
    • Missouri
      • City of Saint Peters, Missouri, Forente stater, 63303
        • StudyMetrix Research
      • Springfield, Missouri, Forente stater, 65807
        • Clinvest Research LLC
    • Montana
      • Kalispell, Montana, Forente stater, 59901
        • Glacier View Research Institute
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68516
        • Physician Research Collaboration, LLC
      • Omaha, Nebraska, Forente stater, 68114
        • Westroads Clinical Research, Inc.
    • Nevada
      • Reno, Nevada, Forente stater, 89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Albuquerque Clinical Trials, Inc.
      • Albuquerque, New Mexico, Forente stater, 87102
        • Albuquerque Center For Rheumatology
      • Santa Fe, New Mexico, Forente stater, 87505
        • Santa Fe Rheumatology
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28211
        • Accellacare - Charlotte
      • Durham, North Carolina, Forente stater, 27704
        • M3-Emerging Medical Research, LLC
      • Hickory, North Carolina, Forente stater, 28602
        • Piedmont Rheumatology, P.A.
      • Leland, North Carolina, Forente stater, 28451
        • Cape Fear Arthritis Care
      • Salisbury, North Carolina, Forente stater, 28144
        • PMG Research of Salisbury
      • Wilmington, North Carolina, Forente stater, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Cincinnati Rheumatic Disease Study Group
      • Marietta, Ohio, Forente stater, 45750
        • Marietta Memorial Hospital
      • Middleburg Heights, Ohio, Forente stater, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • East Penn Rheumatology Associates
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • Clinical Research Center of Reading,LLC
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Regional Health Clinical Research
    • Texas
      • Baytown, Texas, Forente stater, 77521
        • Accurate Clinical Management
      • College Station, Texas, Forente stater, 77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Houston, Texas, Forente stater, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Forente stater, 77089
        • Accurate Clinical Research
      • Houston, Texas, Forente stater, 77084
        • Accurate Clinical Management - Houston
      • Houston, Texas, Forente stater, 77089
        • Research Physicians Network, LLC
      • League City, Texas, Forente stater, 77573
        • Accurate Clinical Research
      • San Antonio, Texas, Forente stater, 78229
        • Accurate Clinical Research, Inc.
      • San Antonio, Texas, Forente stater, 78229
        • Clinical Trials of Texas, Inc.
      • Sugar Land, Texas, Forente stater, 77479
        • Accurate Clinical Management
      • Tomball, Texas, Forente stater, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
      • Tomball, Texas, Forente stater, 77377
        • DM Clinical Research/Rheumatology Clinic of Houston
    • Washington
      • Spokane, Washington, Forente stater, 99204
        • Arthritis Northwest, PLLC
      • Vancouver, Washington, Forente stater, 98664
        • The Vancouver Clinic
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25304
        • CAMC Health Education and Research Institute Inc
  • 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
  • Hellas
    • Attikí
      • Chaïdári, Attikí, Hellas, 12462
        • Attikon General University Hospital
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Hellas, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Évros
      • Alexandroupoli, Évros, Hellas, 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
  • Italia
      • Florence, Italia, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Naples, Italia, 80131
        • University of Campania Luigi Vanvitelli
      • Verona, Italia, 37100
        • Policlinico GB Rossi Borgo Roma
    • Abruzzo
      • Chieti, Abruzzo, Italia, 66013
        • Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
    • Milano
      • Milan, Milano, Italia, 20157
        • Ospedale Luigi Sacco
    • Tuscany
      • Siena, Tuscany, Italia, 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
  • Nederland
    • Limburg
      • Born, Limburg, Nederland, 6121 XK
        • PT&R / PreCare Trial & Recruitment
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Nederland, 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
  • Romania
      • Brăila, Romania, 810019
        • CMI Cristei Dorica
    • Brașov County
      • Brasov, Brașov County, Romania, 500283
        • C.M.D.T.A. Neomed
    • Bucharest
      • Bucharest, Bucharest, Romania, 011172
        • Spital Clinic Sf. Maria
      • Bucharest, Bucharest, Romania, 014142
        • Delta Health Care
      • Bucharest, Bucharest, Romania, 30463
        • CCBR Clinical Research
    • Galați County
      • Galati, Galați County, Romania, 800578
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
    • Iaşi
      • Iași, Iaşi, Romania, 707027
        • RK Medcenter
    • Maramureş
      • Baia Mare, Maramureş, Romania, 430031
        • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romania, 240762
        • SC Medaudio-Optica SRL
  • Russland
      • Petrozavodsk, Russland, 185019
        • Karelia Republican Hospital V.A. Baranova
      • Saratov, Russland, 410053
        • Regional Clinical Hospital of the Saratov Region
      • Yaroslavl, Russland, 150003
        • Research & Practice
    • Kursk Oblast
      • Kursk, Kursk Oblast, Russland, 305007
        • Kursk Regional Clinical Hospital
    • Leningradskaya Oblast'
      • Saint-Petersburg, Leningradskaya Oblast', Russland, 194291
        • Gbuz Lokb
    • Moscow
      • Moscow, Moscow, Russland, 111123
        • Moscow Clinical Research Center
      • Moscow, Moscow, Russland, 115522
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Moscow, Russland, 129110
        • M. F. Vladimirskiy Moscow Regional Research Clinical Institute
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russland, 119991
        • First Moscow State Medical University I.M. Sechenov
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russland, 603005
        • Nizhny Novgorod City Clinical Hospital Number 5
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russland, 390026
        • Ryazan Regional Clinical Cardiological Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russland, 191015
        • North-Western State Medical University named after I.I.Mechnikov
      • Saint Petersburg, Sankt-Peterburg, Russland, 190068
        • Clinical Rheumatology hospital #25
    • Tula Oblast
      • Tula, Tula Oblast, Russland, 300053
        • Tula Regional Clinical Hospital
    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Russland, 432063
        • GUZ UOKB
  • Slovakia
    • Banská Bystrica Region
      • Zvolen, Banská Bystrica Region, Slovakia, 960 01
        • Albamed s.r.o.
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 851 01
        • Romjan s.r.o.
    • Košice Region
      • Košice, Košice Region, Slovakia, 040 11
        • Artromac n.o.
      • Spišská Nová Ves, Košice Region, Slovakia, 05201
        • Reumed s.r.o.
    • Nitra Region
      • Topoľčany, Nitra Region, Slovakia, 955 01
        • LERAM s.r.o.
    • Trenčín Region
      • Partizánske, Trenčín Region, Slovakia, 958 01
        • Reumacentrum s.r.o.
  • Spania
      • Córdoba, Spania, 14004
        • Hospital Quirónsalud Córdoba
      • Córdoba, Spania, 14004
        • HU Reina Sofia
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
      • Seville, Spania, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spania, 41010
        • Hospital Quiron Infanta Luisa
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spania, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, A Coruña [La Coruña], Spania, 15702
        • Clínica Gaias - Santiago
    • Alicante
      • Elche, Alicante, Spania, 03202
        • Hospital General Universitario de Elche
      • Villajoyosa, Alicante, Spania, 03570
        • Hospital Marina Baixa
    • Basque Country
      • Bilbao, Basque Country, Spania, 48013
        • Osi Bilbao-Basurto
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spania, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Catalunya [Cataluña], Spania, 08022
        • Clinica Sagrada Familia
      • Barcelona, Catalunya [Cataluña], Spania, 08023
        • Hospital Quirón Barcelona
      • Sabadell, Catalunya [Cataluña], Spania, 08208
        • Corporacio Sanitaria Parc Tauli
      • Sant Joan Despí, Catalunya [Cataluña], Spania, 08970
        • Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
    • Galicia [Galicia]
      • Santiago de Compostela, Galicia [Galicia], Spania, 15706
        • CHUS - Hospital Clinico Universitario
    • Madrid, Comunidad de
      • Fuenlabrada, Madrid, Comunidad de, Spania, 28944
        • Hospital Universitario de Fuenlabrada
      • Getafe, Madrid, Comunidad de, Spania, 28905
        • Hospital Universitario Getafe
      • Majadahonda, Madrid, Comunidad de, Spania, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Pontevedra [Pontevedra]
      • Vigo, Pontevedra [Pontevedra], Spania, 36200
        • CHUVI- Hospital do Meixoeiro
  • Storbritannia
      • Liverpool, Storbritannia, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Wolverhampton, Storbritannia, WV10 0QP
        • New Cross Hospital
    • Bournemouth
      • Christchurch, Bournemouth, Storbritannia, BH23 2JX
        • Christchurch Hospital
    • Devon
      • Plymouth, Devon, Storbritannia, Pl6 8DH
        • Derriford Hospital
      • Torquay, Devon, Storbritannia, TQ2 7AA
        • Torbay Hospital
    • England
      • Dudley, England, Storbritannia, DY1 2HQ
        • The Dudley Group NHS Foundation Trust
      • London, England, Storbritannia, NW32QG
        • Royal Free London NHS Foundation Trust
      • Truro, England, Storbritannia, TR1 3LJ
        • The Royal Cornwall Hospital
    • Essex
      • Chelmsford, Essex, Storbritannia, CM1 7ET
        • Mid Essex Hospital Services NHS Trust
    • Hampshire
      • Portsmouth, Hampshire, Storbritannia, PO6 3LY
        • Queen Alexandra Hospital
    • Kingston Upon Hull
      • Hull, Kingston Upon Hull, Storbritannia, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust
    • North Tyneside
      • Newcastle upon Tyne, North Tyneside, Storbritannia, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
    • Nottinghamshire
      • Sutton in Ashfield, Nottinghamshire, Storbritannia, NG17 4JL
        • King's Mill Hospital
    • Waltham Forest
      • London, Waltham Forest, Storbritannia, E11 1NR
        • Barts Health NHS Trust - Whipps Cross University Hospital
  • Sveits
      • Fribourg, Sveits, 1708
        • HFR Fribourg - Hôpital Cantonal
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Sveits, 4056
        • University Hospital Basel
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Sveits, 9007
        • Cantonal Hospital St.Gallen
  • Sør-Afrika
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, Sør-Afrika, 6045
        • Netcare Greenacres Hospital
    • Free State
      • Bloemfontein, Free State, Sør-Afrika, 9301
        • Iatros International
      • Bloemfontein, Free State, Sør-Afrika, 9301
        • FARMOVS
    • Gauteng
      • Kempton Park, Gauteng, Sør-Afrika, 1619
        • Clinresco Centres
      • Pretoria, Gauteng, Sør-Afrika, 0001
        • University of Pretoria - Faculty of Health Sciences
    • KwaZulu-Natal
      • Chatsworth, KwaZulu-Natal, Sør-Afrika, 4092
        • Precise Clinical Solutions
      • Umhlanga, KwaZulu-Natal, Sør-Afrika, 4320
        • Netcare Umhlanga Hospital
    • Western Cape
      • Cape Town, Western Cape, Sør-Afrika, 7405
        • Arthritis Clinical Trial Centre
      • Stellenbosch, Western Cape, Sør-Afrika, 7600
        • Winelands Medical Research Centre
  • Tsjekkia
      • Prague, Tsjekkia, 14000
        • Revmatologicka ambulance
      • Prague, Tsjekkia, 14800
        • Affidea Praha, s.r.o.
    • Brno-město
      • Brno, Brno-město, Tsjekkia, 63800
        • Revmatologie.s.r.o.
      • Brno, Brno-město, Tsjekkia, 61500
        • Revmacentrum MUDr. Mostera, s.r.o.
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Tsjekkia, 722 00
        • Artroscan, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Tsjekkia, 70300
        • INREA s.r.o.
    • Pardubice Region
      • Pardubice, Pardubice Region, Tsjekkia, 53002
        • Arthrohelp S.R.O.
    • Praha 10
      • Prague, Praha 10, Tsjekkia, 100 00
        • CLINTRIAL s.r.o.
    • Praha 4
      • Prague, Praha 4, Tsjekkia, 140 00
        • Revmatologie MUDr. Štejfová
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Tsjekkia, 12850
        • Revmatologicky Ustav
    • South Moravian
      • Brno, South Moravian, Tsjekkia, 61141
        • REVMACLINIC s.r.o.
    • Zlín
      • Uherské Hradiště, Zlín, Tsjekkia, 686 01
        • Medical Plus
      • Zlín, Zlín, Tsjekkia, 760 01
        • PV Medical Services s.r.o.
  • Tyrkia (Türkiye)
      • Edirne, Tyrkia (Türkiye), 22030
        • Trakya University
      • Istanbul, Tyrkia (Türkiye), 34098
        • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
      • Izmir, Tyrkia (Türkiye), 35620
        • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
      • Konya, Tyrkia (Türkiye)
        • Necmettin Erbakan Meram Medical Fac.
    • Eskişehir
      • Eskişehir, Eskişehir, Tyrkia (Türkiye), 26480
        • Eskisehir Osmangazi University
    • Istanbul
      • Stanbul, Istanbul, Tyrkia (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
  • Østerrike
      • Vienna, Østerrike, 1100
        • Rheuma-Zentrum Oberlaa GmbH
    • State of Vienna
      • Vienna, State of Vienna, Østerrike, 1090
        • Medizinische Universität Wien
      • Vienna, State of Vienna, Østerrike, 1160
        • Wilhelminenspital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Deltakere må ha minst én av følgende egenskaper:

    • Dokumentert bevis på en VTE før denne studien
    • Minst 60 år
    • En kroppsmasseindeks (BMI) større enn eller lik 30 kilogram per kvadratmeter kvadrat (kg/m²), eller
    • Alder 50 til under 60 år og BMI 25 til mindre enn 30 kg/m².
  • Deltakerne må ha en utilstrekkelig respons eller intoleranse overfor minst 1 sykdomsmodifiserende antirevmatiske legemidler (DMARD) (syntetisk eller biologisk).

Ekskluderingskriterier:

  • Deltakeren skal ikke ha noen grunn til ikke å ta en TNF-hemmer.
  • Deltakere må ikke være gravide eller ammende.
  • Deltakere må ikke ha hatt mer enn én VTE.
  • Deltakere må ikke ha kreft.
  • Deltakere må ikke ha aktiv herpes zoster, alvorlig infeksjon, aktiv tuberkulose eller annen alvorlig sykdom.
  • Deltakerne må ikke ha fått en levende vaksine innen fire uker etter studiestart.
  • Deltakere må ikke ha deltatt i noen annen klinisk utprøving innen fire uker etter studiestart.
  • Deltakere må ikke ha en historie med intravenøs narkotikabruk, annet ulovlig narkotikamisbruk eller kronisk alkoholmisbruk det siste året.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Baricitinib
Administrert oralt.
Andre navn:
  • LY3009104
Eksperimentell: 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.
Legemiddel: Baricitinib
Administrert oralt.
Andre navn:
  • 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.
Legemiddel: TNF Inhibitor
Administered subcutaneously.
Andre navn:
  • Etanercept
  • Adalimumab

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Samarbeidspartnere

Incyte Corporation

Etterforskere

  • 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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. april 2019

Primær fullføring (Faktiske)

28. mai 2025

Studiet fullført (Faktiske)

28. mai 2025

Datoer for studieregistrering

Først innsendt

12. april 2019

Først innsendt som oppfylte QC-kriteriene

12. april 2019

Først lagt ut (Faktiske)

16. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.

IPD-delingstidsramme

Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU, avhengig av hva som er senere. Data vil være tilgjengelig på ubestemt tid for forespørsel.

Tilgangskriterier for IPD-deling

Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere