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COMPLETED
NCT03915964
PHASE4

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2659

Start Date

2019-04-25

Completion Date

2025-05-28

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Baricitinib

Administered orally.

DRUG

TNF Inhibitor

Administered subcutaneously.

Locations (261)

Arizona Arthritis & Rheumatology Research, PLLC

Flagstaff, Arizona, United States

Arthrocare, Arthritiscare & Research PC

Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, United States

Hope Research Institute

Peoria, Arizona, United States

Hope Research Institute

Phoenix, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Tucson, Arizona, United States

Medvin Clinical Research - Covina

Covina, California, United States

St Joseph Heritage Healthcare

Fullerton, California, United States

Christine Thai, MD

Huntington Beach, California, United States

Private Practice - Dr. Christine J. Leehealey

Irvine, California, United States

Desert Medical Advances

Rancho Mirage, California, United States

Rheumatology Center of San Diego

San Diego, California, United States

East Bay Rheumatology Medical Group, Inc

San Leandro, California, United States

Dan La, MD Inc

Tujunga, California, United States

Robin K. Dore MD, Inc

Tustin, California, United States

Inland Rheumatology & Osteoporosis Medical Group

Upland, California, United States

Medvin Clinical Research - Weidmann

Van Nuys, California, United States

Medvin Clinical Research - Whittier

Whittier, California, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Rheumatology Associates of South Florida

Boca Raton, Florida, United States

Suncoast Research Group

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

IRIS Research and Development, LLC

Plantation, Florida, United States

Qps-Mra, Llc

South Miami, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Arthritis & Rheumatology of Georgia

Atlanta, Georgia, United States

Arthritis Center of North Georgia

Gainesville, Georgia, United States

St. Luke's Intermountain Research Center

Boise, Idaho, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Qualmedica Research, LLC

Evansville, Indiana, United States

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Center for Arthritis and Osteoporosis

Elizabethtown, Kentucky, United States

Accurate Clinical Research

Lake Charles, Louisiana, United States

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

University of Michigan

Brighton, Michigan, United States

West Michigan Rheumatology

Grand Rapids, Michigan, United States

Advanced Rheumatology, PC

Okemos, Michigan, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Clinvest Research LLC

Springfield, Missouri, United States

Glacier View Research Institute

Kalispell, Montana, United States

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States

Westroads Clinical Research, Inc.

Omaha, Nebraska, United States

Allied Clinical Research

Reno, Nevada, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

Santa Fe Rheumatology

Santa Fe, New Mexico, United States

Accellacare - Charlotte

Charlotte, North Carolina, United States

M3-Emerging Medical Research, LLC

Durham, North Carolina, United States

Piedmont Rheumatology, P.A.

Hickory, North Carolina, United States

Cape Fear Arthritis Care

Leland, North Carolina, United States

PMG Research of Salisbury

Salisbury, North Carolina, United States

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Cincinnati Rheumatic Disease Study Group

Cincinnati, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

East Penn Rheumatology Associates

Bethlehem, Pennsylvania, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Clinical Research Center of Reading,LLC

Wyomissing, Pennsylvania, United States

Pennsylvania Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, United States

Regional Health Clinical Research

Rapid City, South Dakota, United States

Accurate Clinical Management

Baytown, Texas, United States

Arthritis & Osteoporosis Clinic of Brazos Valley

College Station, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Accurate Clinical Management - Houston

Houston, Texas, United States

Accurate Clinical Research

Houston, Texas, United States

Research Physicians Network, LLC

Houston, Texas, United States

Accurate Clinical Research

League City, Texas, United States

Accurate Clinical Research, Inc.

San Antonio, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Accurate Clinical Management

Sugar Land, Texas, United States

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

Tomball, Texas, United States

DM Clinical Research/Rheumatology Clinic of Houston

Tomball, Texas, United States

Arthritis Northwest, PLLC

Spokane, Washington, United States

The Vancouver Clinic

Vancouver, Washington, United States

CAMC Health Education and Research Institute Inc

Charleston, West Virginia, United States

Optimus Clinical Research

Botany, New South Wales, Australia

Genesis Research Services

Newcastle, New South Wales, Australia

Rheumatology Research Unit

Maroochydore, Queensland, Australia

Southern Clinical Research

Hobart, Tasmania, Australia

Emeritus Research

Camberwell, Victoria, Australia

Medizinische Universität Wien

Vienna, State of Vienna, Austria

Wilhelminenspital

Vienna, State of Vienna, Austria

Rheuma-Zentrum Oberlaa GmbH

Vienna, Austria

Université Libre de Bruxelles - Hôpital Erasme

Brussels, Bruxelles-Capitale, Région de, Belgium

ZNA Jan Palfijn

Merksem, Flanders, Belgium

Reuma Clinic, Locatie Jaarbeurslaan

Genk, Limburg, Belgium

Revmacentrum MUDr. Mostera, s.r.o.

Brno, Brno-město, Czechia

Revmatologie.s.r.o.

Brno, Brno-město, Czechia

Artroscan, s.r.o.

Ostrava, Moravian-Silesian Region, Czechia

INREA s.r.o.

Ostrava, Ostrava Město, Czechia

ARTHROHELP s.r.o.

Pardubice, Pardubice Region, Czechia

Clintrial s.r.o.

Prague, Praha 10, Czechia

Revmatologie MUDr. Štejfová

Prague, Praha 4, Czechia

Revmatologicky ustav

Prague, Praha, Hlavní Mešto, Czechia

REVMACLINIC s.r.o.

Brno, South Moravian, Czechia

Medical Plus

Uherské Hradiště, Zlín, Czechia

PV Medical Services s.r.o.

Zlín, Zlín, Czechia

Revmatologicka ambulance

Prague, Czechia

Affidea Praha, s.r.o.

Prague, Czechia

Regionshospitalet Silkeborg

Silkeborg, Central Jutland, Denmark

Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital

Svendborg, Region Syddanmark, Denmark

CHU de Nice

Nice, Alpes-Maritimes, France

CHU Strasbourg-Hautepierre

Strasbourg, Alsace, France

Bordeaux University Hospital - Pellegrin

Bordeaux, Aquitaine, France

Hôpital Edouard Herriot

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Regional D'Orleans

Orléans, Centre-Val de Loire, France

Hôpital Pierre-Paul Riquet

Toulouse, Haute-Garonne, France

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

Nantes, Loire-Atlantique, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

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

CHD Vendee

La Roche-sur-Yon, Vendée, France

Infirmerie Protestante de Lyon

Caluire-et-Cuire, France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, France

Pitie Salpetriere University Hospital

Paris, France

CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

Frankfurt am Main, Hesse, Germany

Rheumazentrum Prof.Neeck MVZ

Bad Doberan, Mecklenburg-Vorpommern, Germany

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, Germany

Rheumazentrum Ratingen Studienambulanz

Ratingen, North Rhine-Westphalia, Germany

Institut für Präventive Medizin & Klinische Forschung GbR

Magdeburg, Saxony-Anhalt, Germany

Praxis für Rheumatologie und Innere

Berlin, Germany

Schlosspark Klinik

Berlin, Germany

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

Hamburg, Germany

Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz

Hamburg, Germany

Attikon General University Hospital

Chaïdári, Attikí, Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, Greece

University Hospital of Alexandroupolis

Alexandroupoli, Évros, Greece

CRU Hungary Kft.

Miskolc, Borsod-Abauj Zemplen county, Hungary

Revita Clinic

Budapest, Pest County, Hungary

Clinexpert Kft.

Budapest, Pest County, Hungary

Vital Medical Center

Veszprém, Veszprém City, Hungary

Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház

Debrecen, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Meir Medical Center

Kfar Saba, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Barzilai Medical Center

Ashkelon, Southern District, Israel

Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel

Rambam Health Care Campus

Haifa, Ḥeifā, Israel

Carmel Hospital

Haifa, Ḥeifā, Israel

Bnai Zion Medical Center

Haifa, Ḥeifā, Israel

Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio

Chieti, Abruzzo, Italy

Ospedale Luigi Sacco

Milan, Milano, Italy

Ospedale Le Scotte

Siena, Tuscany, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

University of Campania Luigi Vanvitelli

Naples, Italy

Policlinico GB Rossi Borgo Roma

Verona, Italy

Republican Hospital of Kaunas

Kaunas, Kauno Miestas, Lithuania

Centro poliklinika

Vilnius, Lithuania

Respublikin Šiauli ligonin

Šiauliai, Šiauliai County, Lithuania

PT&R / PreCare Trial & Recruitment

Born, Limburg, Netherlands

Medische Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Ai Centrum Medyczne Sp. Z O.O.

Poznan, Greater Poland Voivodeship, Poland

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

Poznan, Greater Poland Voivodeship, Poland

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim

Tomaszów Lubelski, Lublin Voivodeship, Poland

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, Poland

NZOZ Lecznica MAK-MED s.c.

Nadarzyn, Masovian Voivodeship, Poland

Medycyna Kliniczna

Warsaw, Masovian Voivodeship, Poland

Rheuma Medicus- Zaklad Opieki Zdrowotnej

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, Poland

ETG Warszawa

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne AMED Warszawa Targowek

Warsaw, Masovian Voivodeship, Poland

Osteo Medic sc A. Racewicz, J. Supronik

Bialystok, Podlaskie Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

BIF-MED

Bytom, Silesian Voivodeship, Poland

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, Poland

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

Ustroń, Silesian Voivodeship, Poland

Ambulatorium Barbara Bazela

Elblag, Warmian-Masurian Voivodeship, Poland

Centro Reumatologico Caguas

Caguas, Puerto Rico

Ponce Medical School Foundation Inc.

Ponce, Puerto Rico

Latin Clinical Trial Center

San Juan, Puerto Rico

GCM Medical Group, PSC - Hato Rey Site

San Juan, Puerto Rico

Mindful Medical Research

San Juan, Puerto Rico

C.M.D.T.A. Neomed

Brasov, Brașov County, Romania

Spital Clinic Sf. Maria

Bucharest, Bucharest, Romania

Delta Health Care

Bucharest, Bucharest, Romania

CCBR Clinical Research

Bucharest, Bucharest, Romania

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

Galati, Galați County, Romania

RK Medcenter

Iași, Iaşi, Romania

Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare

Baia Mare, Maramureş, Romania

SC MedAudio-Optica SRL

Râmnicu Vâlcea, Vâlcea County, Romania

CMI Cristei Dorica

Brăila, Romania

Kursk Regional Clinical Hospital

Kursk, Kursk Oblast, Russia

Gbuz Lokb

Saint-Petersburg, Leningradskaya Oblast', Russia

Moscow Clinical Research Center

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

M. F. Vladimirskiy Moscow Regional Research Clinical Institute

Moscow, Moscow, Russia

First Moscow State Medical University I.M. Sechenov

Moscow, Moscow Oblast, Russia

Nizhny Novgorod City Clinical Hospital Number 5

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Ryazan Regional Clinical Cardiological Dispensary

Ryazan, Ryazan Oblast, Russia

Clinical Rheumatology hospital #25

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

Tula Regional Clinical Hospital

Tula, Tula Oblast, Russia

GUZ UOKB

Ulyanovsk, Ulyanovsk Oblast, Russia

Karelia Republican Hospital V.A. Baranova

Petrozavodsk, Russia

Regional Clinical Hospital of the Saratov Region

Saratov, Russia

Research & Practice

Yaroslavl, Russia

Albamed s.r.o.

Zvolen, Banská Bystrica Region, Slovakia

Romjan s.r.o.

Bratislava, Bratislava Region, Slovakia

Artromac n.o.

Košice, Košice Region, Slovakia

Reumed s.r.o.

Spišská Nová Ves, Košice Region, Slovakia

LERAM s.r.o.

Topoľčany, Nitra Region, Slovakia

Reumacentrum s.r.o.

Partizánske, Trenčín Region, Slovakia

Netcare Greenacres Hospital

Port Elizabeth, Eastern Cape, South Africa

FARMOVS

Bloemfontein, Free State, South Africa

IATROS International

Bloemfontein, Free State, South Africa

Clinresco Centres

Kempton Park, Gauteng, South Africa

University of Pretoria - Faculty of Health Sciences

Pretoria, Gauteng, South Africa

Precise Clinical Solutions

Chatsworth, KwaZulu-Natal, South Africa

Netcare Umhlanga Hospital

Umhlanga, KwaZulu-Natal, South Africa

Arthritis Clinical Trial Centre

Cape Town, Western Cape, South Africa

Winelands Medical Research Centre

Stellenbosch, Western Cape, South Africa

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], Spain

Clínica Gaias - Santiago

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

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

OSI Bilbao-Basurto

Bilbao, Basque Country, Spain

Clínica Sagrada Familia

Barcelona, Catalunya [Cataluña], Spain

Hospital Quiron Barcelona

Barcelona, Catalunya [Cataluña], Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain

Corporació Sanitària Parc Taulí

Sabadell, Catalunya [Cataluña], Spain

Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí

Sant Joan Despí, Catalunya [Cataluña], Spain

CHUS - Hospital Clinico Universitario

Santiago de Compostela, Galicia [Galicia], Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Comunidad de, Spain

Hospital Universitario Getafe

Getafe, Madrid, Comunidad de, Spain

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Madrid, Comunidad de, Spain

CHUVI- Hospital do Meixoeiro

Vigo, Pontevedra [Pontevedra], Spain

Hospital Quirónsalud Córdoba

Córdoba, Spain

HU Reina Sofia

Córdoba, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Quiron Infanta Luisa

Seville, Spain

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

HFR Fribourg - Hôpital Cantonal

Fribourg, Switzerland

Eskisehir Osmangazi University

Eskişehir, Eskişehir, Turkey (Türkiye)

Marmara Universitesi Pendik Egitim Arastirma Hastanesi

Stanbul, Istanbul, Turkey (Türkiye)

Trakya University

Edirne, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical School Internal Diseases Institute

Istanbul, Turkey (Türkiye)

Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi

Izmir, Turkey (Türkiye)

Necmettin Erbakan Meram Medical Fac.

Konya, Turkey (Türkiye)

Christchurch Hospital

Christchurch, Bournemouth, United Kingdom

Derriford Hospital

Plymouth, Devon, United Kingdom

Torbay Hospital

Torquay, Devon, United Kingdom

The Dudley Group NHS Foundation Trust

Dudley, England, United Kingdom

Royal Free London NHS Foundation Trust

London, England, United Kingdom

The Royal Cornwall Hospital

Truro, England, United Kingdom

Mid Essex Hospital Services NHS Trust

Chelmsford, Essex, United Kingdom

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Hull and East Yorkshire Hospitals NHS Trust

Hull, Kingston Upon Hull, United Kingdom

Northumbria Healthcare NHS Foundation Trust

Newcastle upon Tyne, North Tyneside, United Kingdom

King's Mill Hospital

Sutton in Ashfield, Nottinghamshire, United Kingdom

Barts Health NHS Trust - Whipps Cross University Hospital

London, Waltham Forest, United Kingdom

Aintree University Hospital NHS Foundation Trust

Liverpool, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom