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AzTrials

Rheumatoid ArthritisPhase 4RA-BRIDGENCT03915964

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

A Phase 4 study testing Baricitinib and TNF Inhibitor in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 261 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Baricitinib and TNF Inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,659 participants
Where
261 sitesin 24 countries
Study dates
25 Apr 2019to 28 May 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have at least one of the following characteristics:
  • Documented evidence of a VTE prior to this study
  • At least 60 years of age
  • A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
  • Age 50 to less than 60 years and BMI 25 to less than 30 kg/m².
  • Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (DMARD) (synthetic or biologic).

Who cannot join

  • Participant should have no reason to not take a TNF inhibitor.
  • Participants must not be pregnant or breastfeeding.
  • Participants must not have had more than one VTE.
  • Participants must not have cancer.
  • Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
  • Participants must not have had a live vaccine within four weeks of study start.
  • Participants must not have participated in any other clinical trial within four weeks of study start.
  • Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Trial locations and contacts

261 sites in 24 countries.

261 sites in 24 countries

United States81 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Arthritis & Rheumatology of Georgia

    Atlanta, Georgia, 30342

  • Accurate Clinical Management

    Baytown, Texas, 77521

  • East Penn Rheumatology Associates

    Bethlehem, Pennsylvania, 18015

  • Rheumatology Associates of South Florida

    Boca Raton, Florida, 33486

  • St. Luke's Intermountain Research Center

    Boise, Idaho, 83702

  • University of Michigan

    Brighton, Michigan, 48116

  • CAMC Health Education and Research Institute Inc

    Charleston, West Virginia, 25304

  • Accellacare - Charlotte

    Charlotte, North Carolina, 28211

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45242

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Arthritis & Osteoporosis Clinic of Brazos Valley

    College Station, Texas, 77845

  • Medvin Clinical Research - Covina

    Covina, California, 91722

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • M3-Emerging Medical Research, LLC

    Durham, North Carolina, 27704

  • Center for Arthritis and Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Arizona Arthritis & Rheumatology Research, PLLC

    Flagstaff, Arizona, 86001

  • St Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • Arthrocare, Arthritiscare & Research PC

    Gilbert, Arizona, 85234

  • Arizona Arthritis & Rheumatology Research, PLLC

    Glendale, Arizona, 85306

  • West Michigan Rheumatology

    Grand Rapids, Michigan, 49546

  • Piedmont Rheumatology, P.A.

    Hickory, North Carolina, 28602

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Accurate Clinical Management - Houston

    Houston, Texas, 77084

  • Accurate Clinical Research

    Houston, Texas, 77089

  • Research Physicians Network, LLC

    Houston, Texas, 77089

  • Christine Thai, MD

    Huntington Beach, California, 92648

  • Private Practice - Dr. Christine J. Leehealey

    Irvine, California, 92604

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Accurate Clinical Research

    Lake Charles, Louisiana, 70605

  • Accurate Clinical Research

    League City, Texas, 77573

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona, 85210

  • Suncoast Research Group

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Advanced Rheumatology, PC

    Okemos, Michigan, 48864

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Westroads Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Hope Research Institute

    Peoria, Arizona, 85381

  • Hope Research Institute

    Phoenix, Arizona, 85018

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324

  • Desert Medical Advances

    Rancho Mirage, California, 92270

  • Regional Health Clinical Research

    Rapid City, South Dakota, 57701

  • Allied Clinical Research

    Reno, Nevada, 89519

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Accurate Clinical Research, Inc.

    San Antonio, Texas, 78229

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • East Bay Rheumatology Medical Group, Inc

    San Leandro, California, 94578

  • Santa Fe Rheumatology

    Santa Fe, New Mexico, 87505

  • Qps-Mra, Llc

    South Miami, Florida, 33143

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Accurate Clinical Management

    Sugar Land, Texas, 77479

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Tomball, Texas, 77375

  • DM Clinical Research/Rheumatology Clinic of Houston

    Tomball, Texas, 77377

  • Arizona Arthritis & Rheumatology Research, PLLC

    Tucson, Arizona, 85704

  • Dan La, MD Inc

    Tujunga, California, 91042

  • Robin K. Dore MD, Inc

    Tustin, California, 92780

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California, 91786

  • Medvin Clinical Research - Weidmann

    Van Nuys, California, 91405

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Medvin Clinical Research - Whittier

    Whittier, California, 90602

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Clinical Research Center of Reading,LLC

    Wyomissing, Pennsylvania, 19610

  • Pennsylvania Regional Center for Arthritis and Osteoporosis Research

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Spain21 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña], 15006

  • Clínica Sagrada Familia

    Barcelona, Catalunya [Cataluña], 08022

  • Hospital Quiron Barcelona

    Barcelona, Catalunya [Cataluña], 08023

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036

  • OSI Bilbao-Basurto

    Bilbao, Basque Country, 48013

  • Hospital Quirónsalud Córdoba

    Córdoba, 14004

  • HU Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03202

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, Comunidad de, 28944

  • Hospital Universitario Getafe

    Getafe, Madrid, Comunidad de, 28905

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta De Hierro Majadahonda

    Majadahonda, Madrid, Comunidad de, 28222

  • Corporació Sanitària Parc Taulí

    Sabadell, Catalunya [Cataluña], 08208

  • Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí

    Sant Joan Despí, Catalunya [Cataluña], 08970

  • Clínica Gaias - Santiago

    Santiago de Compostela, A Coruña [La Coruña], 15702

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, Galicia [Galicia], 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Quiron Infanta Luisa

    Seville, 41010

  • CHUVI- Hospital do Meixoeiro

    Vigo, Pontevedra [Pontevedra], 36200

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

Other trials in Spain

Poland18 sites

  • Osteo Medic sc A. Racewicz, J. Supronik

    Bialystok, Podlaskie Voivodeship, 15-351

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • BIF-MED

    Bytom, Silesian Voivodeship, 41-902

  • Ambulatorium Barbara Bazela

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship, 40-081

  • NZOZ Lecznica MAK-MED s.c.

    Nadarzyn, Masovian Voivodeship, 05-830

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100

  • Ai Centrum Medyczne Sp. Z O.O.

    Poznan, Greater Poland Voivodeship, 61-113

  • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

    Poznan, Greater Poland Voivodeship, 61-397

  • Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim

    Tomaszów Lubelski, Lublin Voivodeship, 22-600

  • MICS Centrum Medyczne Torun

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka

    Ustroń, Silesian Voivodeship, 43-450

  • Medycyna Kliniczna

    Warsaw, Masovian Voivodeship, 00-874

  • Rheuma Medicus- Zaklad Opieki Zdrowotnej

    Warsaw, Masovian Voivodeship, 02-118

  • Centrum Medyczne Reuma Park

    Warsaw, Masovian Voivodeship, 02-665

  • ETG Warszawa

    Warsaw, Masovian Voivodeship, 02-677

  • Centrum Medyczne AMED Warszawa Targowek

    Warsaw, Masovian Voivodeship, 03-291

Other trials in Poland

Russia15 sites

  • Kursk Regional Clinical Hospital

    Kursk, Kursk Oblast, 305007

  • Moscow Clinical Research Center

    Moscow, Moscow, 111123

  • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova

    Moscow, Moscow, 115522

  • M. F. Vladimirskiy Moscow Regional Research Clinical Institute

    Moscow, Moscow, 129110

  • First Moscow State Medical University I.M. Sechenov

    Moscow, Moscow Oblast, 119991

  • Nizhny Novgorod City Clinical Hospital Number 5

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603005

  • Karelia Republican Hospital V.A. Baranova

    Petrozavodsk, 185019

  • Ryazan Regional Clinical Cardiological Dispensary

    Ryazan, Ryazan Oblast, 390026

  • Clinical Rheumatology hospital #25

    Saint Petersburg, Sankt-Peterburg, 190068

  • North-Western State Medical University named after I.I.Mechnikov

    Saint Petersburg, Sankt-Peterburg, 191015

  • Gbuz Lokb

    Saint-Petersburg, Leningradskaya Oblast', 194291

  • Regional Clinical Hospital of the Saratov Region

    Saratov, 410053

  • Tula Regional Clinical Hospital

    Tula, Tula Oblast, 300053

  • GUZ UOKB

    Ulyanovsk, Ulyanovsk Oblast, 432063

  • Research & Practice

    Yaroslavl, 150003

Other trials in Russia

United Kingdom14 sites

  • Mid Essex Hospital Services NHS Trust

    Chelmsford, Essex, CM1 7ET

  • Christchurch Hospital

    Christchurch, Bournemouth, BH23 2JX

  • The Dudley Group NHS Foundation Trust

    Dudley, England, DY1 2HQ

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, Kingston Upon Hull, HU3 2JZ

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, L9 7AL

  • Royal Free London NHS Foundation Trust

    London, England, NW32QG

  • Barts Health NHS Trust - Whipps Cross University Hospital

    London, Waltham Forest, E11 1NR

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle upon Tyne, North Tyneside, NE29 8NH

  • Derriford Hospital

    Plymouth, Devon, Pl6 8DH

  • Queen Alexandra Hospital

    Portsmouth, Hampshire, PO6 3LY

  • King's Mill Hospital

    Sutton in Ashfield, Nottinghamshire, NG17 4JL

  • Torbay Hospital

    Torquay, Devon, TQ2 7AA

  • The Royal Cornwall Hospital

    Truro, England, TR1 3LJ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Czechia13 sites

  • Revmacentrum MUDr. Mostera, s.r.o.

    Brno, Brno-město, 61500

  • Revmatologie.s.r.o.

    Brno, Brno-město, 63800

  • REVMACLINIC s.r.o.

    Brno, South Moravian, 61141

  • Artroscan, s.r.o.

    Ostrava, Moravian-Silesian Region, 722 00

  • INREA s.r.o.

    Ostrava, Ostrava Město, 70300

  • ARTHROHELP s.r.o.

    Pardubice, Pardubice Region, 53002

  • Clintrial s.r.o.

    Prague, Praha 10, 100 00

  • Revmatologie MUDr. Štejfová

    Prague, Praha 4, 140 00

  • Revmatologicky ustav

    Prague, Praha, Hlavní Mešto, 12850

  • Revmatologicka ambulance

    Prague, 14000

  • Affidea Praha, s.r.o.

    Prague, 14800

  • Medical Plus

    Uherské Hradiště, Zlín, 686 01

  • PV Medical Services s.r.o.

    Zlín, Zlín, 760 01

Other trials in Czechia

France12 sites

  • Bordeaux University Hospital - Pellegrin

    Bordeaux, Aquitaine, 33076

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300

  • CHD Vendee

    La Roche-sur-Yon, Vendée, 85000

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

    Lille, 59037

  • Hôpital Edouard Herriot

    Lyon, Auvergne-Rhône-Alpes, 69003

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, Loire-Atlantique, 44093

  • CHU de Nice

    Nice, Alpes-Maritimes, 06000

  • Centre Hospitalier Regional D'Orleans

    Orléans, Centre-Val de Loire, 45067

  • Pitie Salpetriere University Hospital

    Paris, 75013

  • CHU Strasbourg-Hautepierre

    Strasbourg, Alsace, 67098

  • Hôpital Pierre-Paul Riquet

    Toulouse, Haute-Garonne, 31059

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Germany9 sites

  • Rheumazentrum Prof.Neeck MVZ

    Bad Doberan, Mecklenburg-Vorpommern, 18209

  • Praxis für Rheumatologie und Innere

    Berlin, 12163

  • Schlosspark Klinik

    Berlin, 14059

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

    Frankfurt am Main, Hesse, 60590

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T

    Hamburg, 20095

  • Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz

    Hamburg, 22391

  • Institut für Präventive Medizin & Klinische Forschung GbR

    Magdeburg, Saxony-Anhalt, 39110

  • Rheumazentrum Ratingen Studienambulanz

    Ratingen, North Rhine-Westphalia, 40878

Other trials in Germany

Romania9 sites

  • Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare

    Baia Mare, Maramureş, 430031

  • CMI Cristei Dorica

    Brăila, 810019

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283

  • Spital Clinic Sf. Maria

    Bucharest, Bucharest, 011172

  • Delta Health Care

    Bucharest, Bucharest, 014142

  • CCBR Clinical Research

    Bucharest, Bucharest, 30463

  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

    Galati, Galați County, 800578

  • RK Medcenter

    Iași, Iaşi, 707027

  • SC MedAudio-Optica SRL

    Râmnicu Vâlcea, Vâlcea County, 240762

Other trials in Romania

South Africa9 sites

  • FARMOVS

    Bloemfontein, Free State, 9301

  • IATROS International

    Bloemfontein, Free State, 9301

  • Arthritis Clinical Trial Centre

    Cape Town, Western Cape, 7405

  • Precise Clinical Solutions

    Chatsworth, KwaZulu-Natal, 4092

  • Clinresco Centres

    Kempton Park, Gauteng, 1619

  • Netcare Greenacres Hospital

    Port Elizabeth, Eastern Cape, 6045

  • University of Pretoria - Faculty of Health Sciences

    Pretoria, Gauteng, 0001

  • Winelands Medical Research Centre

    Stellenbosch, Western Cape, 7600

  • Netcare Umhlanga Hospital

    Umhlanga, KwaZulu-Natal, 4320

Other trials in South Africa

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, Southern District, 7830604

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601

  • Carmel Hospital

    Haifa, Ḥeifā, 3436212

  • Bnai Zion Medical Center

    Haifa, Ḥeifā

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906

Other trials in Israel

Hungary6 sites

  • Revita Clinic

    Budapest, Pest County, 1027

  • Clinexpert Kft.

    Budapest, Pest County, 1033

  • Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház

    Debrecen, 4031

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • CRU Hungary Kft.

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Vital Medical Center

    Veszprém, Veszprém City, 8200

Other trials in Hungary

Italy6 sites

  • Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio

    Chieti, Abruzzo, 66013

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50141

  • Ospedale Luigi Sacco

    Milan, Milano, 20157

  • University of Campania Luigi Vanvitelli

    Naples, 80131

  • Ospedale Le Scotte

    Siena, Tuscany, 53100

  • Policlinico GB Rossi Borgo Roma

    Verona, 37100

Other trials in Italy

Slovakia6 sites

  • Romjan s.r.o.

    Bratislava, Bratislava Region, 851 01

  • Artromac n.o.

    Košice, Košice Region, 040 11

  • Reumacentrum s.r.o.

    Partizánske, Trenčín Region, 958 01

  • Reumed s.r.o.

    Spišská Nová Ves, Košice Region, 05201

  • LERAM s.r.o.

    Topoľčany, Nitra Region, 955 01

  • Albamed s.r.o.

    Zvolen, Banská Bystrica Region, 960 01

Other trials in Slovakia

Turkey (Türkiye)6 sites

  • Trakya University

    Edirne, 22030

  • Eskisehir Osmangazi University

    Eskişehir, Eskişehir, 26480

  • Istanbul University Cerrahpasa Medical School Internal Diseases Institute

    Istanbul, 34098

  • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi

    Izmir, 35620

  • Necmettin Erbakan Meram Medical Fac.

    Konya

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Stanbul, Istanbul, 34899

Other trials in Turkey (Türkiye)

Australia5 sites

  • Optimus Clinical Research

    Botany, New South Wales, 2019

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Southern Clinical Research

    Hobart, Tasmania, 7000

  • Rheumatology Research Unit

    Maroochydore, Queensland, 4558

  • Genesis Research Services

    Newcastle, New South Wales, 2292

Other trials in Australia

Puerto Rico5 sites

  • Centro Reumatologico Caguas

    Caguas, 00725

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

  • Latin Clinical Trial Center

    San Juan, 00909

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

  • Mindful Medical Research

    San Juan, 00918

Other trials in Puerto Rico

Austria3 sites

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

  • Wilhelminenspital

    Vienna, State of Vienna, 1160

  • Rheuma-Zentrum Oberlaa GmbH

    Vienna, 1100

Other trials in Austria

Belgium3 sites

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, Bruxelles-Capitale, Région de, 1070

  • Reuma Clinic, Locatie Jaarbeurslaan

    Genk, Limburg, 3600

  • ZNA Jan Palfijn

    Merksem, Flanders, 2170

Other trials in Belgium

Greece3 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, Évros, 68100

  • Attikon General University Hospital

    Chaïdári, Attikí, 12462

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 54642

Other trials in Greece

Lithuania3 sites

  • Republican Hospital of Kaunas

    Kaunas, Kauno Miestas, 45130

  • Respublikin Šiauli ligonin

    Šiauliai, Šiauliai County, 76231

  • Centro poliklinika

    Vilnius, 01117

Other trials in Lithuania

Switzerland3 sites

  • University Hospital Basel

    Basel, Canton of Basel-City, 4056

  • HFR Fribourg - Hôpital Cantonal

    Fribourg, 1708

  • Cantonal Hospital St.Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Denmark2 sites

  • Regionshospitalet Silkeborg

    Silkeborg, Central Jutland, 8600

  • Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital

    Svendborg, Region Syddanmark, 5700

Other trials in Denmark

Netherlands2 sites

  • PT&R / PreCare Trial & Recruitment

    Born, Limburg, 6121 XK

  • Medische Centrum Leeuwarden

    Leeuwarden, Provincie Friesland, 8934 AD

Other trials in Netherlands

About this study

Official title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

Being tested
Baricitinib, TNF Inhibitor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally.

  • TNF InhibitorDrug

    Also called Etanercept, Adalimumab

    Administered subcutaneously.

Study groups in NCT03915964
Study groupRoleWhat they receive
Baricitinib 2mgExperimentalParticipants 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.
Receives: Drug: Baricitinib
Baricitinib 4mgExperimentalParticipants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Receives: Drug: Baricitinib
Tumor Necrosis Factor (TNF) InhibitorActive comparatorParticipants 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.
Receives: Drug: TNF Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 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)

Secondary outcomes (6)

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

    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.

    Measured: 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)

  2. 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]

    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.

    Measured: 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)

  3. 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]

    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.

    Measured: 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)

  4. 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]

    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.

    Measured: 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)

  5. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    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.

    Measured: 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)

  6. Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start25 Apr 2019
  3. Primary completion28 May 2025
  4. Study completion28 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,659 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03915964
Sponsor's protocol ID
17172
Other IDs
I4V-MC-JAJA, 2018-003351-37, 2023-508022-10-00, 2023, 2018
Acronym
RA-BRIDGE
Status last verified
May 2026
First submitted
12 Apr 2019
Last updated
24 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Baricitinib and TNF Inhibitor in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 261 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in United States, Spain, Poland, Russia, United Kingdom and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor] (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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