Uno studio su Baricitinib (LY3009104) nei partecipanti con artrite reumatoide (RA-BRIDGE)
27 maggio 2026 aggiornato da: Eli Lilly and Company
Uno studio randomizzato, con controllo attivo, a gruppi paralleli, di fase 3b/4 su Baricitinib in pazienti con artrite reumatoide
Questo studio post-marketing è progettato per confrontare la sicurezza di baricitinib rispetto agli inibitori del fattore di necrosi tumorale (TNF) rispetto agli eventi tromboembolici venosi (VTE) quando somministrato a partecipanti con artrite reumatoide.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
2659
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New South Wales
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Botany, New South Wales, Australia, 2019
- Optimus Clinical Research
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Newcastle, New South Wales, Australia, 2292
- Genesis Research Services
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Queensland
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Maroochydore, Queensland, Australia, 4558
- Rheumatology Research Unit
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Tasmania
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Hobart, Tasmania, Australia, 7000
- Southern Clinical Research
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research
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Vienna, Austria, 1100
- Rheuma-Zentrum Oberlaa GmbH
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Medizinische Universität Wien
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Vienna, State of Vienna, Austria, 1160
- Wilhelminenspital
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Bruxelles-Capitale, Région de
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Brussels, Bruxelles-Capitale, Région de, Belgio, 1070
- Université Libre de Bruxelles - Hôpital Erasme
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Flanders
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Merksem, Flanders, Belgio, 2170
- ZNA Jan Palfijn
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Limburg
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Genk, Limburg, Belgio, 3600
- Reuma Clinic, Locatie Jaarbeurslaan
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Prague, Cechia, 14000
- Revmatologicka ambulance
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Prague, Cechia, 14800
- Affidea Praha, s.r.o.
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Brno-město
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Brno, Brno-město, Cechia, 63800
- Revmatologie.s.r.o.
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Brno, Brno-město, Cechia, 61500
- Revmacentrum MUDr. Mostera, s.r.o.
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Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Cechia, 722 00
- Artroscan, s.r.o.
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Ostrava Město
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Ostrava, Ostrava Město, Cechia, 70300
- INREA s.r.o.
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Pardubice Region
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Pardubice, Pardubice Region, Cechia, 53002
- Arthrohelp S.R.O.
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Praha 10
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Prague, Praha 10, Cechia, 100 00
- CLINTRIAL s.r.o.
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Praha 4
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Prague, Praha 4, Cechia, 140 00
- Revmatologie MUDr. Štejfová
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Praha, Hlavní Mešto
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Prague, Praha, Hlavní Mešto, Cechia, 12850
- Revmatologicky Ustav
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South Moravian
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Brno, South Moravian, Cechia, 61141
- REVMACLINIC s.r.o.
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Zlín
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Uherské Hradiště, Zlín, Cechia, 686 01
- Medical Plus
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Zlín, Zlín, Cechia, 760 01
- PV Medical Services s.r.o.
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Central Jutland
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Silkeborg, Central Jutland, Danimarca, 8600
- Regionshospitalet Silkeborg
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Region Syddanmark
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Svendborg, Region Syddanmark, Danimarca, 5700
- Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital
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Caluire-et-Cuire, Francia, 69300
- Infirmerie Protestante de Lyon
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Lille, Francia, 59037
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
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Paris, Francia, 75013
- Pitie Salpetriere University Hospital
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Francia, 06000
- Chu De Nice
-
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Alsace
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Strasbourg, Alsace, Francia, 67098
- CHU Strasbourg-Hautepierre
-
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Aquitaine
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Bordeaux, Aquitaine, Francia, 33076
- Bordeaux University Hospital - Pellegrin
-
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Francia, 69003
- Hôpital Edouard Herriot
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Centre-Val de Loire
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Orléans, Centre-Val de Loire, Francia, 45067
- Centre Hospitalier Régional d'Orléans
-
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Haute-Garonne
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Toulouse, Haute-Garonne, Francia, 31059
- Hôpital Pierre-Paul Riquet
-
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Loire-Atlantique
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Nantes, Loire-Atlantique, Francia, 44093
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
-
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Francia, 54511
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
-
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Vendée
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La Roche-sur-Yon, Vendée, Francia, 85000
- CHD Vendée
-
-
-
-
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Berlin, Germania, 14059
- Schlosspark Klinik
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Berlin, Germania, 12163
- Praxis für Rheumatologie und Innere
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Hamburg, Germania, 22391
- Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz
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Hamburg, Germania, 20095
- HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
-
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Hesse
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Frankfurt am Main, Hesse, Germania, 60590
- CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
-
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Mecklenburg-Vorpommern
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Bad Doberan, Mecklenburg-Vorpommern, Germania, 18209
- Rheumazentrum Prof.Neeck MVZ
-
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Germania, 50937
- Universitaetsklinikum Koeln
-
Ratingen, North Rhine-Westphalia, Germania, 40878
- Rheumazentrum Ratingen Studienambulanz
-
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Saxony-Anhalt
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Magdeburg, Saxony-Anhalt, Germania, 39110
- Institut für Präventive Medizin & Klinische Forschung GbR
-
-
-
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Attikí
-
Chaïdári, Attikí, Grecia, 12462
- Attikon General University Hospital
-
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Kentrikí Makedonía
-
Thessaloniki, Kentrikí Makedonía, Grecia, 54642
- Ippokrateio General Hospital of Thessaloniki
-
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Évros
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Alexandroupoli, Évros, Grecia, 68100
- University Hospital of Alexandroupolis
-
-
-
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Central District
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Kfar Saba, Central District, Israele, 4428164
- Meir Medical Center
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Ramat Gan, Central District, Israele, 5262100
- Sheba medical center
-
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Southern District
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Ashkelon, Southern District, Israele, 7830604
- Barzilai Medical Center
-
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Tell Abīb
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Tel Aviv, Tell Abīb, Israele, 6423906
- Sourasky Medical Center
-
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Ḥeifā
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Haifa, Ḥeifā, Israele, 3109601
- Rambam Health Care Campus
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Haifa, Ḥeifā, Israele, 3436212
- Carmel Hospital
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Haifa, Ḥeifā, Israele
- Bnai Zion Medical Center
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-
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Florence, Italia, 50141
- Azienda Ospedaliera Universitaria Careggi
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Naples, Italia, 80131
- University of Campania Luigi Vanvitelli
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Verona, Italia, 37100
- Policlinico GB Rossi Borgo Roma
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Abruzzo
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Chieti, Abruzzo, Italia, 66013
- Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
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Milano
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Milan, Milano, Italia, 20157
- Ospedale Luigi Sacco
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Tuscany
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Siena, Tuscany, Italia, 53100
- Ospedale Le Scotte
-
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Vilnius, Lituania, 01117
- Centro poliklinika
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Kauno Miestas
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Kaunas, Kauno Miestas, Lituania, 45130
- Republican Hospital of Kaunas
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Šiauliai County
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Šiauliai, Šiauliai County, Lituania, 76231
- Respublikin Šiauli ligonin
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Limburg
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Born, Limburg, Olanda, 6121 XK
- PT&R / PreCare Trial & Recruitment
-
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Provincie Friesland
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Leeuwarden, Provincie Friesland, Olanda, 8934 AD
- Medische Centrum Leeuwarden
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia, 61-113
- Ai Centrum Medyczne Sp. Z O.O.
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Poznan, Greater Poland Voivodeship, Polonia, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-168
- Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
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Torun, Kuyavian-Pomeranian Voivodeship, Polonia, 87-100
- MICS Centrum Medyczne Toruń
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Lublin Voivodeship
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Tomaszów Lubelski, Lublin Voivodeship, Polonia, 22-600
- Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Polonia, 67-100
- Twoja Przychodnia Centrum Medyczne Nowa Sol
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Masovian Voivodeship
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Nadarzyn, Masovian Voivodeship, Polonia, 05-830
- NZOZ Lecznica MAK-MED s.c.
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Warsaw, Masovian Voivodeship, Polonia, 02-677
- ETG Warszawa
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Warsaw, Masovian Voivodeship, Polonia, 02-665
- Centrum Medyczne Reuma Park
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Warsaw, Masovian Voivodeship, Polonia, 00-874
- Medycyna Kliniczna
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Warsaw, Masovian Voivodeship, Polonia, 02-118
- Rheuma Medicus- Zaklad Opieki Zdrowotnej
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Warsaw, Masovian Voivodeship, Polonia, 03-291
- Centrum Medyczne AMED Warszawa Targówek
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-351
- Osteo Medic sc A. Racewicz, J. Supronik
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polonia, 80-546
- Centrum Badan Klinicznych PI-House sp. z o.o.
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Polonia, 41-902
- BIF-MED
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Katowice, Silesian Voivodeship, Polonia, 40-081
- Centrum Medyczne Pratia Katowice
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Ustroń, Silesian Voivodeship, Polonia, 43-450
- Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
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Warmian-Masurian Voivodeship
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Elblag, Warmian-Masurian Voivodeship, Polonia, 82-300
- Ambulatorium Barbara Bazela
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-
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Caguas, Porto Rico, 00725
- Centro Reumatologico Caguas
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Ponce, Porto Rico, 00716
- Ponce Medical School Foundation Inc.
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San Juan, Porto Rico, 00918
- Mindful Medical Research
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San Juan, Porto Rico, 00909
- Latin Clinical Trial Center
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San Juan, Porto Rico, 00917
- GCM Medical Group, PSC - Hato Rey Site
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-
-
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Liverpool, Regno Unito, L9 7AL
- Aintree University Hospital NHS Foundation Trust
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Wolverhampton, Regno Unito, WV10 0QP
- New Cross Hospital
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Bournemouth
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Christchurch, Bournemouth, Regno Unito, BH23 2JX
- Christchurch Hospital
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Devon
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Plymouth, Devon, Regno Unito, Pl6 8DH
- Derriford Hospital
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Torquay, Devon, Regno Unito, TQ2 7AA
- Torbay Hospital
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England
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Dudley, England, Regno Unito, DY1 2HQ
- The Dudley Group NHS Foundation Trust
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London, England, Regno Unito, NW32QG
- Royal Free London NHS Foundation Trust
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Truro, England, Regno Unito, TR1 3LJ
- The Royal Cornwall Hospital
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Essex
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Chelmsford, Essex, Regno Unito, CM1 7ET
- Mid Essex Hospital Services NHS Trust
-
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Hampshire
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Portsmouth, Hampshire, Regno Unito, PO6 3LY
- Queen Alexandra Hospital
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Kingston Upon Hull
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Hull, Kingston Upon Hull, Regno Unito, HU3 2JZ
- Hull and East Yorkshire Hospitals NHS Trust
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North Tyneside
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Newcastle upon Tyne, North Tyneside, Regno Unito, NE29 8NH
- Northumbria Healthcare NHS Foundation Trust
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Nottinghamshire
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Sutton in Ashfield, Nottinghamshire, Regno Unito, NG17 4JL
- King's Mill Hospital
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Waltham Forest
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London, Waltham Forest, Regno Unito, E11 1NR
- Barts Health NHS Trust - Whipps Cross University Hospital
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-
-
-
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Brăila, Romania, 810019
- CMI Cristei Dorica
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Brașov County
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Brasov, Brașov County, Romania, 500283
- C.M.D.T.A. Neomed
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Bucharest
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Bucharest, Bucharest, Romania, 011172
- Spital Clinic Sf. Maria
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Bucharest, Bucharest, Romania, 014142
- Delta Health Care
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Bucharest, Bucharest, Romania, 30463
- CCBR Clinical Research
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Galați County
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Galati, Galați County, Romania, 800578
- Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
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Iaşi
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Iași, Iaşi, Romania, 707027
- RK Medcenter
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Maramureş
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Baia Mare, Maramureş, Romania, 430031
- Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
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Vâlcea County
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Râmnicu Vâlcea, Vâlcea County, Romania, 240762
- SC Medaudio-Optica SRL
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-
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-
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Petrozavodsk, Russia, 185019
- Karelia Republican Hospital V.A. Baranova
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Saratov, Russia, 410053
- Regional Clinical Hospital of the Saratov Region
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Yaroslavl, Russia, 150003
- Research & Practice
-
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Kursk Oblast
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Kursk, Kursk Oblast, Russia, 305007
- Kursk Regional Clinical Hospital
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Leningradskaya Oblast'
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Saint-Petersburg, Leningradskaya Oblast', Russia, 194291
- Gbuz Lokb
-
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Moscow
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Moscow, Moscow, Russia, 111123
- Moscow Clinical Research Center
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Moscow, Moscow, Russia, 115522
- Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
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Moscow, Moscow, Russia, 129110
- M. F. Vladimirskiy Moscow Regional Research Clinical Institute
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Moscow Oblast
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Moscow, Moscow Oblast, Russia, 119991
- First Moscow State Medical University I.M. Sechenov
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603005
- Nizhny Novgorod City Clinical Hospital Number 5
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Ryazan Oblast
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Ryazan, Ryazan Oblast, Russia, 390026
- Ryazan Regional Clinical Cardiological Dispensary
-
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russia, 191015
- North-Western State Medical University named after I.I.Mechnikov
-
Saint Petersburg, Sankt-Peterburg, Russia, 190068
- Clinical Rheumatology hospital #25
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Tula Oblast
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Tula, Tula Oblast, Russia, 300053
- Tula Regional Clinical Hospital
-
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Ulyanovsk Oblast
-
Ulyanovsk, Ulyanovsk Oblast, Russia, 432063
- GUZ UOKB
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-
-
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Banská Bystrica Region
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Zvolen, Banská Bystrica Region, Slovacchia, 960 01
- Albamed s.r.o.
-
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Bratislava Region
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Bratislava, Bratislava Region, Slovacchia, 851 01
- Romjan s.r.o.
-
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Košice Region
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Košice, Košice Region, Slovacchia, 040 11
- Artromac n.o.
-
Spišská Nová Ves, Košice Region, Slovacchia, 05201
- Reumed s.r.o.
-
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Nitra Region
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Topoľčany, Nitra Region, Slovacchia, 955 01
- LERAM s.r.o.
-
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Trenčín Region
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Partizánske, Trenčín Region, Slovacchia, 958 01
- Reumacentrum s.r.o.
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-
-
-
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Córdoba, Spagna, 14004
- Hospital Quirónsalud Córdoba
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Córdoba, Spagna, 14004
- HU Reina Sofia
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Madrid, Spagna, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spagna, 28046
- Hospital Universitario La Paz
-
Seville, Spagna, 41009
- Hospital Universitario Virgen Macarena
-
Seville, Spagna, 41010
- Hospital Quiron Infanta Luisa
-
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A Coruña [La Coruña]
-
A Coruña, A Coruña [La Coruña], Spagna, 15006
- Complejo Hospitalario Universitario A Coruña
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Santiago de Compostela, A Coruña [La Coruña], Spagna, 15702
- Clínica Gaias - Santiago
-
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Alicante
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Elche, Alicante, Spagna, 03202
- Hospital General Universitario de Elche
-
Villajoyosa, Alicante, Spagna, 03570
- Hospital Marina Baixa
-
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Basque Country
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Bilbao, Basque Country, Spagna, 48013
- Osi Bilbao-Basurto
-
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Catalunya [Cataluña]
-
Barcelona, Catalunya [Cataluña], Spagna, 08036
- Hospital Clinic de Barcelona
-
Barcelona, Catalunya [Cataluña], Spagna, 08022
- Clinica Sagrada Familia
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Barcelona, Catalunya [Cataluña], Spagna, 08023
- Hospital Quirón Barcelona
-
Sabadell, Catalunya [Cataluña], Spagna, 08208
- Corporacio Sanitaria Parc Tauli
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Sant Joan Despí, Catalunya [Cataluña], Spagna, 08970
- Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
-
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Galicia [Galicia]
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Santiago de Compostela, Galicia [Galicia], Spagna, 15706
- CHUS - Hospital Clinico Universitario
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Madrid, Comunidad de
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Fuenlabrada, Madrid, Comunidad de, Spagna, 28944
- Hospital Universitario de Fuenlabrada
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Getafe, Madrid, Comunidad de, Spagna, 28905
- Hospital Universitario Getafe
-
Majadahonda, Madrid, Comunidad de, Spagna, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
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Pontevedra [Pontevedra]
-
Vigo, Pontevedra [Pontevedra], Spagna, 36200
- CHUVI- Hospital do Meixoeiro
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-
-
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Arizona
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Flagstaff, Arizona, Stati Uniti, 86001
- Arizona Arthritis & Rheumatology Research, PLLC
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Gilbert, Arizona, Stati Uniti, 85234
- Arthrocare, Arthritiscare & Research PC
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Glendale, Arizona, Stati Uniti, 85306
- Arizona Arthritis & Rheumatology Research, PLLC
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Mesa, Arizona, Stati Uniti, 85210
- Arizona Arthritis & Rheumatology Research, PLLC
-
Peoria, Arizona, Stati Uniti, 85381
- HOPE Research Institute
-
Phoenix, Arizona, Stati Uniti, 85018
- HOPE Research Institute
-
Tucson, Arizona, Stati Uniti, 85704
- Arizona Arthritis & Rheumatology Research, PLLC
-
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California
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Covina, California, Stati Uniti, 91722
- Medvin Clinical Research - Covina
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Fullerton, California, Stati Uniti, 92835
- St Joseph Heritage Healthcare
-
Huntington Beach, California, Stati Uniti, 92648
- Christine Thai, MD
-
Irvine, California, Stati Uniti, 92604
- Private Practice - Dr. Christine J. Leehealey
-
Rancho Mirage, California, Stati Uniti, 92270
- Desert Medical Advances
-
San Diego, California, Stati Uniti, 92128
- Rheumatology Center of San Diego
-
San Leandro, California, Stati Uniti, 94578
- East Bay Rheumatology Medical Group, Inc
-
Tujunga, California, Stati Uniti, 91042
- Dan La, MD Inc
-
Tustin, California, Stati Uniti, 92780
- Robin K. Dore MD, Inc
-
Upland, California, Stati Uniti, 91786
- Inland Rheumatology & Osteoporosis Medical Group
-
Van Nuys, California, Stati Uniti, 91405
- Medvin Clinical Research - Weidmann
-
Whittier, California, Stati Uniti, 90602
- Medvin Clinical Research - Whittier
-
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Connecticut
-
Stamford, Connecticut, Stati Uniti, 06905
- Stamford Therapeutics Consortium
-
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Florida
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Boca Raton, Florida, Stati Uniti, 33486
- Rheumatology Associates of South Florida
-
Miami, Florida, Stati Uniti, 33165
- New Horizon Research Center
-
Miami, Florida, Stati Uniti, 33135
- Suncoast Research Group
-
New Port Richey, Florida, Stati Uniti, 34652
- Suncoast Clinical Research, Inc.
-
Plantation, Florida, Stati Uniti, 33324
- IRIS Research and Development, LLC
-
South Miami, Florida, Stati Uniti, 33143
- Qps-Mra, Llc
-
Tampa, Florida, Stati Uniti, 33613
- ForCare Clinical Research
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30342
- Arthritis & Rheumatology of Georgia
-
Gainesville, Georgia, Stati Uniti, 30501
- Arthritis Center of North Georgia
-
-
Idaho
-
Boise, Idaho, Stati Uniti, 83702
- St. Luke's Intermountain Research Center
-
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Illinois
-
Chicago, Illinois, Stati Uniti, 60640
- Great Lakes Clinical Trials
-
-
Indiana
-
Evansville, Indiana, Stati Uniti, 47715
- Qualmedica Research, LLC
-
-
Kansas
-
Wichita, Kansas, Stati Uniti, 67205
- Alliance for Multispecialty Research, LLC
-
-
Kentucky
-
Elizabethtown, Kentucky, Stati Uniti, 42701
- Center For Arthritis and Osteoporosis
-
-
Louisiana
-
Lake Charles, Louisiana, Stati Uniti, 70605
- Accurate Clinical Research
-
-
Maryland
-
Wheaton, Maryland, Stati Uniti, 20902
- The Center For Rheumatology And Bone Research
-
-
Massachusetts
-
Fall River, Massachusetts, Stati Uniti, 02721
- NECCR PrimaCare Research
-
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Michigan
-
Brighton, Michigan, Stati Uniti, 48116
- University of Michigan
-
Grand Rapids, Michigan, Stati Uniti, 49546
- West Michigan Rheumatology
-
Okemos, Michigan, Stati Uniti, 48864
- Advanced Rheumatology, PC
-
-
Missouri
-
City of Saint Peters, Missouri, Stati Uniti, 63303
- StudyMetrix Research
-
Springfield, Missouri, Stati Uniti, 65807
- Clinvest Research LLC
-
-
Montana
-
Kalispell, Montana, Stati Uniti, 59901
- Glacier View Research Institute
-
-
Nebraska
-
Lincoln, Nebraska, Stati Uniti, 68516
- Physician Research Collaboration, LLC
-
Omaha, Nebraska, Stati Uniti, 68114
- Westroads Clinical Research, Inc.
-
-
Nevada
-
Reno, Nevada, Stati Uniti, 89519
- Allied Clinical Research
-
-
New Hampshire
-
Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth-Hitchcock Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Stati Uniti, 87102
- Albuquerque Clinical Trials, Inc.
-
Albuquerque, New Mexico, Stati Uniti, 87102
- Albuquerque Center For Rheumatology
-
Santa Fe, New Mexico, Stati Uniti, 87505
- Santa Fe Rheumatology
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28211
- Accellacare - Charlotte
-
Durham, North Carolina, Stati Uniti, 27704
- M3-Emerging Medical Research, LLC
-
Hickory, North Carolina, Stati Uniti, 28602
- Piedmont Rheumatology, P.A.
-
Leland, North Carolina, Stati Uniti, 28451
- Cape Fear Arthritis Care
-
Salisbury, North Carolina, Stati Uniti, 28144
- PMG Research of Salisbury
-
Wilmington, North Carolina, Stati Uniti, 28401
- PMG Research of Wilmington, LLC
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45242
- Cincinnati Rheumatic Disease Study Group
-
Marietta, Ohio, Stati Uniti, 45750
- Marietta Memorial Hospital
-
Middleburg Heights, Ohio, Stati Uniti, 44130
- Paramount Medical Research & Consulting, LLC
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma Medical Research Foundation
-
Oklahoma City, Oklahoma, Stati Uniti, 73103
- Health Research of Oklahoma
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Stati Uniti, 18015
- East Penn Rheumatology Associates
-
Duncansville, Pennsylvania, Stati Uniti, 16635
- Altoona Center for Clinical Research
-
Wyomissing, Pennsylvania, Stati Uniti, 19610
- Clinical Research Center of Reading,LLC
-
Wyomissing, Pennsylvania, Stati Uniti, 19610
- Pennsylvania Regional Center for Arthritis and Osteoporosis Research
-
-
South Dakota
-
Rapid City, South Dakota, Stati Uniti, 57701
- Regional Health Clinical Research
-
-
Texas
-
Baytown, Texas, Stati Uniti, 77521
- Accurate Clinical Management
-
College Station, Texas, Stati Uniti, 77845
- Arthritis & Osteoporosis Clinic of Brazos Valley
-
Houston, Texas, Stati Uniti, 77043
- Biopharma Informatic, LLC
-
Houston, Texas, Stati Uniti, 77089
- Accurate Clinical Research
-
Houston, Texas, Stati Uniti, 77084
- Accurate Clinical Management - Houston
-
Houston, Texas, Stati Uniti, 77089
- Research Physicians Network, LLC
-
League City, Texas, Stati Uniti, 77573
- Accurate Clinical Research
-
San Antonio, Texas, Stati Uniti, 78229
- Accurate Clinical Research, Inc.
-
San Antonio, Texas, Stati Uniti, 78229
- Clinical Trials of Texas, Inc.
-
Sugar Land, Texas, Stati Uniti, 77479
- Accurate Clinical Management
-
Tomball, Texas, Stati Uniti, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
Tomball, Texas, Stati Uniti, 77377
- DM Clinical Research/Rheumatology Clinic of Houston
-
-
Washington
-
Spokane, Washington, Stati Uniti, 99204
- Arthritis Northwest, PLLC
-
Vancouver, Washington, Stati Uniti, 98664
- The Vancouver Clinic
-
-
West Virginia
-
Charleston, West Virginia, Stati Uniti, 25304
- CAMC Health Education and Research Institute Inc
-
-
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, Sud Africa, 6045
- Netcare Greenacres Hospital
-
-
Free State
-
Bloemfontein, Free State, Sud Africa, 9301
- Iatros International
-
Bloemfontein, Free State, Sud Africa, 9301
- FARMOVS
-
-
Gauteng
-
Kempton Park, Gauteng, Sud Africa, 1619
- Clinresco Centres
-
Pretoria, Gauteng, Sud Africa, 0001
- University of Pretoria - Faculty of Health Sciences
-
-
KwaZulu-Natal
-
Chatsworth, KwaZulu-Natal, Sud Africa, 4092
- Precise Clinical Solutions
-
Umhlanga, KwaZulu-Natal, Sud Africa, 4320
- Netcare Umhlanga Hospital
-
-
Western Cape
-
Cape Town, Western Cape, Sud Africa, 7405
- Arthritis Clinical Trial Centre
-
Stellenbosch, Western Cape, Sud Africa, 7600
- Winelands Medical Research Centre
-
-
-
-
-
Fribourg, Svizzera, 1708
- HFR Fribourg - Hôpital Cantonal
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Svizzera, 4056
- University Hospital Basel
-
-
Canton of St. Gallen
-
Sankt Gallen, Canton of St. Gallen, Svizzera, 9007
- Cantonal Hospital St.Gallen
-
-
-
-
-
Edirne, Turchia (Türkiye), 22030
- Trakya University
-
Istanbul, Turchia (Türkiye), 34098
- Istanbul University Cerrahpasa Medical School Internal Diseases Institute
-
Izmir, Turchia (Türkiye), 35620
- Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
-
Konya, Turchia (Türkiye)
- Necmettin Erbakan Meram Medical Fac.
-
-
Eskişehir
-
Eskişehir, Eskişehir, Turchia (Türkiye), 26480
- Eskisehir Osmangazi University
-
-
Istanbul
-
Stanbul, Istanbul, Turchia (Türkiye), 34899
- Marmara Universitesi Pendik Egitim Arastirma Hastanesi
-
-
-
-
-
Debrecen, Ungheria, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Debrecen, Ungheria, 4031
- Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
-
-
Borsod-Abauj Zemplen county
-
Miskolc, Borsod-Abauj Zemplen county, Ungheria, 3529
- CRU Hungary Kft.
-
-
Pest County
-
Budapest, Pest County, Ungheria, 1027
- Revita Clinic
-
Budapest, Pest County, Ungheria, 1033
- Clinexpert Kft.
-
-
Veszprém City
-
Veszprém, Veszprém City, Ungheria, 8200
- Vital Medical Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
I partecipanti devono avere almeno una delle seguenti caratteristiche:
- Evidenza documentata di un TEV prima di questo studio
- Almeno 60 anni di età
- Un indice di massa corporea (BMI) maggiore o uguale a 30 chilogrammi per metro quadrato (kg/m²), o
- Età da 50 a meno di 60 anni e BMI da 25 a meno di 30 kg/m².
- I partecipanti devono avere una risposta inadeguata o intolleranza ad almeno 1 farmaci antireumatici modificanti la malattia (DMARD) (sintetici o biologici).
Criteri di esclusione:
- Il partecipante non dovrebbe avere motivo di non assumere un inibitore del TNF.
- I partecipanti non devono essere in gravidanza o in allattamento.
- I partecipanti non devono aver avuto più di un TEV.
- I partecipanti non devono avere il cancro.
- I partecipanti non devono avere herpes zoster attivo, infezione grave, tubercolosi attiva o qualsiasi altra malattia grave.
- I partecipanti non devono aver ricevuto un vaccino vivo entro quattro settimane dall'inizio dello studio.
- I partecipanti non devono aver partecipato a nessun altro studio clinico entro quattro settimane dall'inizio dello studio.
- I partecipanti non devono avere una storia di uso di droghe per via endovenosa, abuso di altre droghe illecite o abuso cronico di alcol nell'ultimo anno.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Somministrato per via orale.
Altri nomi:
|
|
Sperimentale: 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.
|
Somministrato per via orale.
Altri nomi:
|
|
Comparatore attivo: 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.
|
Administered subcutaneously.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Lasso di tempo: 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:
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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: 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
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
25 aprile 2019
Completamento primario (Effettivo)
28 maggio 2025
Completamento dello studio (Effettivo)
28 maggio 2025
Date di iscrizione allo studio
Primo inviato
12 aprile 2019
Primo inviato che soddisfa i criteri di controllo qualità
12 aprile 2019
Primo Inserito (Effettivo)
16 aprile 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Artrite
- Malattie articolari
- Malattie reumatiche
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie della pelle e del tessuto connettivo
- Artrite, reumatoide
- Agenti antinfiammatori
- Peptidi
- Aminoacidi, peptidi e proteine
- Proteine
- Azioni farmacologiche
- Azioni e usi chimici
- Usi terapeutici
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Recettori, superficie cellulare
- Proteine della membrana
- Frammenti FC di immunoglobulina
- Frammenti di immunoglobulina
- Frammenti di peptidi
- Regioni costanti di immunoglobulina
- Recettori, fattore di necrosi tumorale
- Recettori, citochine
- Recettori, immunologici
- Etanercept
- Adalimumab
- Inibitori del fattore di necrosi tumorale
- baricitinib
Altri numeri di identificazione dello studio
- 17172
- I4V-MC-JAJA (Altro identificatore: Eli Lilly and Company)
- 2018-003351-37 (Numero EudraCT)
- 2023-508022-10-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
I dati anonimi a livello di singolo paziente saranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e di un accordo di condivisione dei dati firmato.
Periodo di condivisione IPD
I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'UE, se successiva.
I dati saranno disponibili a tempo indeterminato per la richiesta.
Criteri di accesso alla condivisione IPD
Una proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .