A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
RA-BRIDGE
A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
3 other identifiers
interventional
2,663
23 countries
258
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Apr 2019
Longer than P75 for phase_4 rheumatoid-arthritis
258 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
April 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2025
CompletedJuly 22, 2025
July 1, 2025
6.1 years
April 12, 2019
July 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
Time from First Dose of Study Treatment to First Event of VTE
Baseline through Study Completion (Approximately 5.5 Years)
Secondary Outcomes (5)
Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Opportunistic Infection
Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Serious Infection
Baseline through Study Completion (Approximately 5.5 Years)
Study Arms (3)
Baricitinib Low Dose
EXPERIMENTALBaricitinib administered orally.
Baricitinib High Dose
EXPERIMENTALBaricitinib administered orally.
TNF Inhibitor
ACTIVE COMPARATORAdalimumab or etanercept administered subcutaneously (SC) per standard of care.
Interventions
Administered orally.
Eligibility Criteria
You may qualify if:
- 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 drugs (DMARD) (synthetic or biologic).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (261)
Arizona Arthritis & Rheumatology Research, PLLC
Flagstaff, Arizona, 86001, United States
Arthrocare, Arthritiscare & Research Pc
Gilbert, Arizona, 85234, United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85210, United States
Hope Research Institute
Peoria, Arizona, 85381, United States
Hope Research Institute
Phoenix, Arizona, 85018, United States
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona, 85704, United States
Medvin Clinical Research - Covina
Covina, California, 91722, United States
St Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Christine Thai, MD
Huntington Beach, California, 92648, United States
Private Practice - Dr. Christine J. Leehealey
Irvine, California, 92604, United States
Desert Medical Advances
Rancho Mirage, California, 92270, United States
Rheumatology Center of San Diego
San Diego, California, 92128, United States
East Bay Rheumatology Medical Group, Inc
San Leandro, California, 94578, United States
Dan La, MD Inc
Tujunga, California, 91042, United States
Robin K. Dore MD, Inc
Tustin, California, 92780, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786, United States
Medvin Clinical Research - Weidmann
Van Nuys, California, 91405, United States
Medvin Clinical Research - Whittier
Whittier, California, 90602, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Rheumatology Associates of South Florida
Boca Raton, Florida, 33486, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Arthritis & Rheumatology of Georgia
Atlanta, Georgia, 30342, United States
Arthritis Center of North Georgia
Gainesville, Georgia, 30501, United States
St. Luke's Intermountain Research Center
Boise, Idaho, 83702, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67205, United States
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Accurate Clinical Research
Lake Charles, Louisiana, 70605, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
University of Michigan
Brighton, Michigan, 48116, United States
West Michigan Rheumatology
Grand Rapids, Michigan, 49546, United States
Advanced Rheumatology, PC
Okemos, Michigan, 48864, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Glacier View Research Institute
Kalispell, Montana, 59901, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Westroads Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Allied Clinical Research
Reno, Nevada, 89519, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Santa Fe Rheumatology
Santa Fe, New Mexico, 87505, United States
Accellacare - Charlotte
Charlotte, North Carolina, 28211, United States
M3-Emerging Medical Research, LLC
Durham, North Carolina, 27704, United States
Piedmont Rheumatology, P.A.
Hickory, North Carolina, 28602, United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45242, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, 18015, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, 19610, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Regional Health Clinical Research
Rapid City, South Dakota, 57701, United States
Accurate Clinical Management
Baytown, Texas, 77521, United States
Arthritis & Osteoporosis Clinic of Brazos Valley
College Station, Texas, 77845, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Accurate Clinical Management - Houston
Houston, Texas, 77084, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Research Physicians Network, LLC
Houston, Texas, 77089, United States
Accurate Clinical Research
League City, Texas, 77573, United States
Accurate Clinical Research, Inc.
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Accurate Clinical Management
Sugar Land, Texas, 77479, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
DM Clinical Research/Rheumatology Clinic of Houston
Tomball, Texas, 77377, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
CAMC Health Education and Research Institute Inc
Charleston, West Virginia, 25304, United States
Optimus Clinical Research
Botany, New South Wales, 2019, Australia
Genesis Research Services
Newcastle, New South Wales, 2292, Australia
Rheumatology Research Unit
Maroochydore, Queensland, 4558, Australia
Southern Clinical Research
Hobart, Tasmania, 7000, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Medizinische Universität Wien
Vienna, Vienna, 1090, Austria
Wilhelminenspital
Vienna, Vienna, 1160, Austria
Rheuma-Zentrum Oberlaa GmbH
Vienna, 1100, Austria
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-Capitale, Région de, 1070, Belgium
ZNA Jan Palfijn
Merksem, Flanders, 2170, Belgium
Reuma Clinic, Locatie Jaarbeurslaan
Genk, Limburg, 3600, Belgium
Revmacentrum MUDr. Mostera, s.r.o.
Brno, Brno-město, 61500, Czechia
Revmatologie.s.r.o.
Brno, Brno-město, 63800, Czechia
Artroscan, s.r.o.
Ostrava, Moravskoslezský kraj, 722 00, Czechia
INREA s.r.o.
Ostrava, Ostrava Město, 70300, Czechia
ARTHROHELP s.r.o.
Pardubice, Pardubický kraj, 53002, Czechia
Clintrial s.r.o.
Prague, Praha 10, 100 00, Czechia
Revmatologie MUDr. Štejfová
Prague, Praha 4, 140 00, Czechia
Revmatologicky ustav
Prague, Praha, Hlavní Mešto, 12850, Czechia
REVMACLINIC s.r.o.
Brno, South Moravian, 61141, Czechia
Medical Plus
Uherské Hradiště, Zlín, 686 01, Czechia
PV Medical Services s.r.o.
Zlín, Zlín, 760 01, Czechia
Revmatologicka ambulance
Prague, 14000, Czechia
Affidea Praha, s.r.o.
Prague, 14800, Czechia
Regionshospitalet Silkeborg
Silkeborg, Central Jutland, 8600, Denmark
Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital
Svendborg, Region Syddanmark, 5700, Denmark
CHU de Nice
Nice, Alpes-Maritimes, 06000, France
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, 67098, France
Bordeaux University Hospital - Pellegrin
Bordeaux, Aquitaine, 33076, France
Hôpital Edouard Herriot
Lyon, Auvergne-Rhône-Alpes, 69003, France
Centre Hospitalier Regional D'Orleans
Orléans, Centre-Val de Loire, 45067, France
Hôpital Pierre-Paul Riquet
Toulouse, Haute-Garonne, 31059, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CHD Vendee
La Roche-sur-Yon, Vendée, 85000, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, 59037, France
Pitie Salpetriere University Hospital
Paris, 75013, France
CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
Frankfurt am Main, Hesse, 60590, Germany
Rheumazentrum Prof.Neeck MVZ
Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Rheumazentrum Ratingen Studienambulanz
Ratingen, North Rhine-Westphalia, 40878, Germany
Institut für Präventive Medizin & Klinische Forschung GbR
Magdeburg, Saxony-Anhalt, 39110, Germany
Praxis für Rheumatologie und Innere
Berlin, 12163, Germany
Schlosspark Klinik
Berlin, 14059, Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg, 20095, Germany
Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz
Hamburg, 22391, Germany
Attikon General University Hospital
Chaïdári, Attikí, 12462, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 54642, Greece
University Hospital of Alexandroupolis
Alexanroupolis, Évros, 68100, Greece
CRU Hungary Kft.
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Revita Clinic
Budapest, Pest County, 1027, Hungary
Clinexpert Kft.
Budapest, Pest County, 1033, Hungary
Vital Medical Center
Veszprém, Veszprém City, 8200, Hungary
Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
Debrecen, 4031, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Meir Medical Center
Kfar Saba, Central District, 4428164, Israel
Sheba Medical Center
Ramat Gan, Central District, 5262100, Israel
Barzilai Medical Center
Ashkelon, Southern District, 7830604, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, 6423906, Israel
Rambam Health Care Campus
Haifa, Ḥeifā, 3109601, Israel
Carmel Hospital
Haifa, Ḥeifā, 3436212, Israel
Bnai Zion Medical Center
Haifa, Ḥeifā, Israel
Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio
Chieti, Abruzzo, 66013, Italy
Ospedale Luigi Sacco
Milan, Milano, 20157, Italy
Ospedale Le Scotte
Siena, Tuscany, 53100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50141, Italy
University of Campania Luigi Vanvitelli
Napoli, 80131, Italy
Policlinico GB Rossi Borgo Roma
Verona, 37100, Italy
Republican Hospital of Kaunas
Kaunas, Kauno Miestas, 45130, Lithuania
Centro poliklinika
Vilnius, 01117, Lithuania
Respublikin Šiauli ligonin
Šiauliai, Šiauliai County, 76231, Lithuania
PT&R / PreCare Trial & Recruitment
Born, Limburg, 6121 XK, Netherlands
Medische Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Ai Centrum Medyczne Sp. Z O.O.
Poznan, Greater Poland Voivodeship, 61-113, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, Greater Poland Voivodeship, 61-397, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
MICS Centrum Medyczne Torun
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim
Tomaszów Lubelski, Lublin Voivodeship, 22-600, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, Masovian Voivodeship, 05-830, Poland
Medycyna Kliniczna
Warsaw, Masovian Voivodeship, 00-874, Poland
Rheuma Medicus- Zak��ad Opieki Zdrowotnej
Warsaw, Masovian Voivodeship, 02-118, Poland
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665, Poland
ETG Warszawa
Warsaw, Masovian Voivodeship, 02-677, Poland
Centrum Medyczne AMED Warszawa Targowek
Warsaw, Masovian Voivodeship, 03-291, Poland
Osteo Medic sc A. Racewicz, J. Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
BIF-MED
Bytom, Silesian Voivodeship, 41-902, Poland
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, 40-081, Poland
Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka
Ustroń, Silesian Voivodeship, 43-450, Poland
Ambulatorium Barbara Bazela
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Centro Reumatologico Caguas
Caguas, 00725, Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283, Romania
Cmi Cristei Dorica
Brăila, Brăila County, 810019, Romania
Spital Clinic Sf. Maria
Bucharest, București, 011172, Romania
Delta Health Care
Bucharest, București, 014142, Romania
CCBR Clinical Research
Bucharest, București, 30463, Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
Galati, Galați County, 800578, Romania
RK Medcenter
Iași, Iaşi, 707027, Romania
Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare
Baia Mare, Maramureş, 430031, Romania
Sc Medaudio-Optica Srl
Râmnicu Vâlcea, Vâlcea County, 240762, Romania
Kursk Regional Clinical Hospital
Kursk, Kursk Oblast, 305007, Russia
Gbuz Lokb
Saint-Petersburg, Leningradskaya Oblast', 194291, Russia
Moscow Clinical Research Center
Moscow, Moscow, 111123, Russia
Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
Moscow, Moscow, 115522, Russia
M. F. Vladimirskiy Moscow Regional Research Clinical Institute
Moscow, Moscow, 129110, Russia
First Moscow State Medical University I.M. Sechenov
Moscow, Moscow Oblast, 119991, Russia
Nizhny Novgorod City Clinical Hospital Number 5
Nizhny Novgorod, Nizhny Novgorod Oblast, 603005, Russia
Ryazan Regional Clinical Cardiological Dispensary
Ryazan, Ryazan Oblast, 390026, Russia
Clinical Rheumatology hospital #25
Saint Petersburg, Sankt-Peterburg, 190068, Russia
North-Western State Medical University named after I.I.Mechnikov
Saint Petersburg, Sankt-Peterburg, 191015, Russia
Tula Regional Clinical Hospital
Tula, Tula Oblast, 300053, Russia
GUZ UOKB
Ulyanovsk, Ulyanovsk Oblast, 432063, Russia
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, 185019, Russia
Regional Clinical Hospital of the Saratov Region
Saratov, 410053, Russia
Research & Practice
Yaroslavl, 150003, Russia
ALBAMED s.r.o.
Zvolen, Banská Bystrica Region, 960 01, Slovakia
ROMJAN s.r.o.
Bratislava, Bratislava Region, 851 01, Slovakia
Artromac n.o.
Košice, Košice Region, 040 11, Slovakia
REUMED s.r.o.
Spišská Nová Ves, Košice Region, 05201, Slovakia
LERAM s.r.o.
Topoľčany, Nitra Region, 955 01, Slovakia
Reumacentrum s.r.o.
Partizánske, Trenčín Region, 958 01, Slovakia
Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, 6045, South Africa
FARMOVS
Bloemfontein, Free State, 9301, South Africa
Iatros International
Bloemfontein, Free State, 9301, South Africa
Clinresco Centres
Kempton Park, Gauteng, 1619, South Africa
University of Pretoria - Faculty of Health Sciences
Pretoria, Gauteng, 0001, South Africa
Precise Clinical Solutions
Chatsworth, KwaZulu-Natal, 4092, South Africa
Netcare Umhlanga Hospital
Umhlanga, KwaZulu-Natal, 4320, South Africa
Arthritis Clinical Trial Centre
Cape Town, Western Cape, 7405, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600, South Africa
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006, Spain
Clínica Gaias - Santiago
Santiago de Compostela, A Coruña [La Coruña], 15702, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03202, Spain
Hospital Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Osi Bilbao-Basurto
Bilbao, Basque Country, 48013, Spain
Clínica Sagrada Familia
Barcelona, Catalunya [Cataluña], 08022, Spain
Hospital Quiron Barcelona
Barcelona, Catalunya [Cataluña], 08023, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036, Spain
Corporació Sanitària Parc Taulí
Sabadell, Catalunya [Cataluña], 08208, Spain
Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí
Sant Joan Despí, Catalunya [Cataluña], 08970, Spain
Hu Reina Sofia
Córdoba, Córdoba, 14004, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Galicia [Galicia], 15706, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Comunidad de, 28944, Spain
Hospital Universitario Getafe
Getafe, Madrid, Comunidad de, 28905, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222, Spain
CHUVI- Hospital do Meixoeiro
Vigo, Pontevedra [Pontevedra], 36200, Spain
Hospital Quirónsalud Córdoba
Córdoba, 14004, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
University Hospital Basel
Basel, Canton of Basel-City, 4056, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
HFR Fribourg - Hôpital Cantonal
Fribourg, 1708, Switzerland
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26480, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Stanbul, Istanbul, 34899, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical School Internal Diseases Institute
Istanbul, 34098, Turkey (Türkiye)
Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
Izmir, 35620, Turkey (Türkiye)
Necmettin Erbakan Meram Medical Fac.
Konya, Turkey (Türkiye)
Christchurch Hospital
Christchurch, Bournemouth, BH23 2JX, United Kingdom
Derriford Hospital
Plymouth, Devon, Pl6 8DH, United Kingdom
Torbay Hospital
Torquay, Devon, TQ2 7AA, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, England, DY1 2HQ, United Kingdom
Royal Free London NHS Foundation Trust
London, England, NW32QG, United Kingdom
The Royal Cornwall Hospital
Truro, England, TR1 3LJ, United Kingdom
Mid Essex Hospital Services NHS Trust
Chelmsford, Essex, CM1 7ET, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, Kingston Upon Hull, HU3 2JZ, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne, North Tyneside, NE29 8NH, United Kingdom
King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Barts Health NHS Trust - Whipps Cross University Hospital
London, Waltham Forest, E11 1NR, United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
April 25, 2019
Primary Completion
May 28, 2025
Study Completion
May 28, 2025
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.