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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03915964
Other study ID # 17172
Secondary ID I4V-MC-JAJA2018-
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date April 25, 2019
Est. completion date February 1, 2026

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2600
Est. completion date February 1, 2026
Est. primary completion date April 14, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Baricitinib
Administered orally.
TNF Inhibitor
Administered SC

Locations

Country Name City State
Australia Optimus Clinical Research Botany New South Wales
Australia Emeritus Research Camberwell Victoria
Australia Southern Clinical Research Hobart Tasmania
Australia Rheumatology Research Unit Maroochydore Queensland
Australia Genesis Research Services Newcastle New South Wales
Austria Medizinische Universität Wien Vienna Wien
Austria Wilhelminenspital Vienna Wien
Austria Rheuma-Zentrum Oberlaa GmbH Wien
Belgium Université Libre de Bruxelles - Hôpital Erasme Brussels Bruxelles-Capitale, Région De
Belgium Reuma Clinic, Locatie Jaarbeurslaan Genk Limburg
Belgium ZNA Jan Palfijn Merksem Vlaams Gewest
Czechia Revmacentrum MUDr. Mostera, s.r.o. Brno Brno-mesto
Czechia Revmaclinic, s.r.o Brno Jihomoravský Kraj
Czechia Revmatologie.s.r.o. Brno Brno-mesto
Czechia Artroscan, s.r.o. Ostrava Moravskoslezský Kraj
Czechia INREA s.r.o. Ostrava Ostrava Mesto
Czechia ARTHROHELP s.r.o. Pardubice Pardubický Kraj
Czechia Clintrial s.r.o. Praha Praha 10
Czechia Affidea Praha, s.r.o. Praha 11
Czechia Revmatologicky ustav Praha 2 Praha, Hlavní Mešto
Czechia Revmatologicka ambulance Praha 4
Czechia Revmatologie MUDr. Štejfová Praha 4
Czechia Medical Plus Uherske Hradiste Zlínský Kraj
Czechia PV Medical Services s.r.o. Zlin Zlínský Kraj
Denmark Regionshospitalet Silkeborg Silkeborg Midtjylland
Denmark Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital Svendborg Syddanmark
France Bordeaux University Hospital- Pellegrin Bordeaux Aquitaine
France Infirmerie Protestante de Lyon Caluire-et-Cuire
France Hôpital Edouard Herriot Lyon Rhône-Alpes
France Chu de Nice Nice Alpes-Maritimes
France Centre Hospitalier Regional D'Orleans Orléans Centre
France Pitie Salpetriere University Hospital Paris
France CHU Strasbourg-Hautepierre Strasbourg Alsace
France Hôpital Pierre-Paul Riquet Toulouse Haute-Garonne
France CHD Vendee Vendée La Roche-sur-Yon
Germany Rheumazentrum Prof.Neeck MVZ Bad Doberan Mecklenburg-Vorpommern
Germany Praxis für Rheumatologie und Innere Berlin
Germany Schlosspark Klinik Berlin
Germany CIRI- Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology Frankfurt Hessen
Germany Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz Hamburg
Germany HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T Hamburg
Germany University Hospital of Cologne Köln Nordrhein-Westfalen
Germany Institut für Präventive Medizin & Klinische Forschung GbR Magdeburg Sachsen-Anhalt
Germany Rheumazentrum Ratingen Studienambulanz Ratingen Nordrhein-Westfalen
Greece University Hospital of Alexandroupolis Alexandroupolis Évros
Greece Attikon General University Hospital Chaidari Attikí
Greece Ippokrateio General Hospital of Thessaloniki Thessaloniki Kentrikí Makedonía
Hungary Clinexpert Tatabánya Ltd. Budapest Pest
Hungary Revita Clinic Budapest Pest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary CRU Hungary Kft. Miskolc Borsod-Abauj-Zemplen
Hungary Vital Medical Center Veszprem Veszprém City
Israel Barzilai Medical Center Ashkelon HaDarom
Israel Bnai Zion Medical Center Haifa
Israel Carmel Hospital Haifa
Israel Rambam Health Care Campus Haifa ?eifa
Israel Meir Medical Center Kfar Saba HaMerkaz
Israel Sheba Medical Center Ramat Gan HaMerkaz
Israel Sourasky Medical Center Tel Aviv Tell Abib
Italy Clinical Research Center - Universita Degli Studi Gabriele d'Annunzio Chieti Abruzzo
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Università degli studi della Campania Luigi Vanvitelli Napoli
Italy Ospedale Le Scotte Siena Toscana
Italy Policlinico GB Rossi Borgo Roma Verona
Lithuania Republican Hospital of Kaunas Kaunas Kauno Miestas
Lithuania Respublikine Siauliu Ligonine Siauliai
Lithuania Centro Poliklinika Vilnius
Netherlands PT&R / PreCare Trial & Recruitment Born Limburg
Netherlands Medische Centrum Leeuwarden Leeuwarden Fryslân
Poland Osteo Medic sc A. Racewicz, J. Supronik Bialystok Podlaskie
Poland Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej Bydgoszcz Kujawsko-pomorskie
Poland BIF-MED Bytom Slaskie
Poland Ambulatorium Barbara Bazela Elblag Warminsko-Mazurki
Poland Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie
Poland Centrum Medyczne Pratia Katowice Katowice Slaskie
Poland NZOZ Lecznica MAK-MED s.c. Nadarzyn Mazowieckie
Poland Twoja Przychodnia Centrum Medyczne Nowa Sol Nowa Sol Lubuskie
Poland Ai Centrum Medyczne Sp. Z O.O. Sp.K. Poznan Wielkopolskie
Poland Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj Poznan Wielkopolskie
Poland Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim Tomaszów Lubelski Lubelskie
Poland MICS Centrum Medyczne Torun Torun Kujawsko-pomorskie
Poland Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka Ustron Slaskie
Poland Centrum Medyczne AMED Warszawa Targowek Warszawa Mazowieckie
Poland Centrum Medyczne Reuma Park Warszawa Mazowieckie
Poland ETG Warszawa Warszawa Mazowieckie
Poland Medycyna Kliniczna Warszawa Mazowieckie
Poland Rheuma Medicus- Zak??ad Opieki Zdrowotnej Warszawa Mazowieckie
Puerto Rico Centro Reumatologico Caguas Caguas
Puerto Rico Ponce Medical School Foundation Inc. Ponce
Puerto Rico GCM Medical Group, PSC- Hato Rey San Juan
Puerto Rico Latin Clinical Trial Center San Juan
Puerto Rico Mindful Medical Research San Juan
Romania Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare Baia Mare Maramures
Romania Cmi Cristei Dorica Braila Braila
Romania C.M.D.T.A. Neomed Brasov Bra?ov
Romania Delta Health Care Bucharest Bucure?ti
Romania CCBR Clinical Research Bucuresti Bucure?ti
Romania Spital Clinic Sf. Maria Bucuresti Bucure?ti
Romania Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati
Romania RK Medcenter Iasi Ia?i
Romania Sc Medaudio-Optica Srl Râmnicu Vâlcea Valcea
Russian Federation Kursk Regional Clinical Hospital Kursk Kurskaya Oblast
Russian Federation Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova Moscow
Russian Federation First Moscow State Medical University n.a. Sechenov Moscow Moskovskaya Oblast
Russian Federation M. F. Vladimirskiy Moscow Regional Research Clinical Institute Moscow Moskva
Russian Federation Moscow Clinical Research Center Moscow Moskva
Russian Federation Nizhny Novgorod City Clinical Hospital Number 5 Nizhny Novgorod Nizhegorodskaya Oblast
Russian Federation Karelia Republican Hospital V.A. Baranova Petrozavodsk
Russian Federation Ryazan Regional Clinincal Cardiology Dispensary Ryazan Ryazanskaya Oblast
Russian Federation Clinical Rheumatology hospital #25 Saint-Petersburg Sankt-Peterburg
Russian Federation Gbuz Lokb Saint-Petersburg Leningradskaya Oblast'
Russian Federation Regional Clinical Hospital of the Saratov Region Saratov
Russian Federation North-Western State Medical University named after I.I.Mechnikov St. Petersburg Sankt-Peterburg
Russian Federation Tula Regional Clinical Hospital Tula Tul'skaya Oblast'
Russian Federation GUZ UOKB Ul'yanovsk Ul'yanovskaya Oblast
Russian Federation Research & Practice Yaroslavl Yaroslavskaya Oblast'
Slovakia ROMJAN s.r.o. Bratislava Bratislavský Kraj
Slovakia Artromac n.o. Kosice Košický Kraj
Slovakia Reumacentrum s.r.o. Partizanske Trenciansky Kraj
Slovakia REUMED s.r.o. Spisska Nova Ves Košický Kraj
Slovakia LERAM s.r.o. Topolcany Nitriansky Kraj
Slovakia ALBAMED s.r.o. Zvolen Banskobystrický Kraj
South Africa FARMOVS Bloemfontein Free State
South Africa Iatros International Bloemfontein Free State
South Africa Arthritis Clinical Trial Centre Cape Town Western Cape
South Africa Precise Clinical Solutions Chatsworth Kwazulu-Natal
South Africa Clinresco Centres Kempton Park Gauteng
South Africa Netcare Greenacres Hospital Port Elizabeth Eastern Cape
South Africa University of Pretoria - Faculty of Health Sciences Pretoria Gauteng
South Africa Winelands Medical Research Centre Stellenbosch Western Cape
South Africa Netcare Umhlanga Hospital Umhlanga Kwazulu-Natal
Spain CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña A Coruña [La Coruña]
Spain Clínica Sagrada Familia Barcelona Catalunya [Cataluña]
Spain Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña]
Spain Hospital Quiron Barcelona Barcelona Catalunya [Cataluña]
Spain Osi Bilbao-Basurto Bilbo País Vasco
Spain Hospital Quirónsalud Córdoba Córdoba
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital Universitario de Fuenlabrada Fuenlabrada Madrid, Comunidad De
Spain Hospital Universitario Getafe Getafe Madrid, Comunidad De
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitari Parc Tauli 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 Clínica Gaias - Santiago Santiago de Compostela A Coruña [La Coruña]
Spain Hospital Quiron Infanta Luisa Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
Spain CHUVI- Hospital do Meixoeiro Vigo Pontevedra [Pontevedra]
Spain Hospital Marina Baixa Villajoyosa Alicante
Switzerland University Hospital Basel Basel Basel-Stad
Switzerland HFR Fribourg - Hôpital Cantonal Fribourg
Switzerland Cantonal Hospital St.Gallen st.Gallen Sankt Gallen
Turkey Trakya University Edirne
Turkey Istanbul University Cerrahpasa Medical School Internal Diseases Institute Istanbul
Turkey Marmara Universitesi Pendik Egitim Arastirma Hastanesi Istanbul
Turkey Izmir Katip Celebi Universitesi Ataturk Egitim Ve Arastrma Hastanesi Izmir
Turkey Necmettin Erbakan Meram Medical Fac. Konya
United Kingdom Mid Essex Hospital Services NHS Trust Chelmsford Essex
United Kingdom Christchurch Hospital Christchurch Bournemouth
United Kingdom The Dudley Group NHS Foundation Trust Dudley England
United Kingdom Hull and East Yorkshire Hospitals NHS Trust Hull Kingston Upon Hull
United Kingdom Aintree University Hospital NHS Foundation Trust Liverpool
United Kingdom Barts Health NHS Trust - Whipps Cross University Hospital London Waltham Forest
United Kingdom Royal Free London NHS Foundation Trust London England
United Kingdom Northumbria Healthcare NHS Foundation Trust Newcastle upon Tyne North Tyneside
United Kingdom Derriford Hospital Plymouth Devon
United Kingdom Queen Alexandra Hospital Portsmouth Hampshire
United Kingdom King's Mill Hospital Sutton In Ashfield Nottinghamshire
United Kingdom Torbay Hospital Torquay Devon
United Kingdom The Royal Cornwall Hospital Truro England
United Kingdom New Cross Hospital Wolverhampton
United States Albuquerque Center for Rheumatology Albuquerque New Mexico
United States Albuquerque Clinical Trials, Inc. Albuquerque New Mexico
United States Arthritis & Rheumatology of Georgia Atlanta Georgia
United States Accurate Clinical Management Baytown Texas
United States East Penn Rheumatology Associates Bethlehem Pennsylvania
United States Rheumatology Associates of South Florida Boca Raton Florida
United States St. Luke's Intermountain Research Center Boise Idaho
United States University of Michigan Brighton Michigan
United States Accellacare - Charlotte Charlotte North Carolina
United States Great Lakes Clinical Trials - Andersonville Chicago Illinois
United States Cincinnati Rheumatic Disease Study Group Cincinnati Ohio
United States Arthritis & Osteoporosis Clinic of Brazos Valley College Station Texas
United States Medvin Clinical Research - Metyas Covina California
United States Altoona Center For Clinical Research Duncansville Pennsylvania
United States M3-Emerging Medical Research, LLC Durham North Carolina
United States Center for Arthritis and Osteoporosis Elizabethtown Kentucky
United States Qualmedica Research, LLC Evansville Indiana
United States NECCR PrimaCare Research Fall River Massachusetts
United States Arizona Arthritis & Rheumatology Research, PLLC Flagstaff Arizona
United States Providence Medical Foundation Fullerton California
United States Arthritis Center of North Georgia Gainesville Georgia
United States Arthrocare, Arthritiscare & Research Pc Gilbert Arizona
United States Arizona Arthritis & Rheumatology Research, PLLC Glendale Arizona
United States West Michigan Rheumatology Grand Rapids Michigan
United States Piedmont Rheumatology, P.A. Hickory North Carolina
United States Accurate Clinical Management - Houston Houston Texas
United States Accurate Clinical Research Houston Texas
United States Biopharma Informatic, LLC Houston Texas
United States DM Clinical Research/Rheumatology Clinic of Houston Houston Texas
United States Laila A Hassan, MD, PA Houston Texas
United States Christine Thai, MD Huntington Beach California
United States Private Practice - Dr. Christine J. Leehealey Irvine California
United States Glacier View Research Institute Kalispell Montana
United States Accurate Clinical Research Lake Charles Louisiana
United States Advanced Rheumatology, PC Lansing Michigan
United States Accurate Clinical Research League City Texas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Cape Fear Arthritis Care Leland North Carolina
United States Physician Research Collaboration, LLC Lincoln Nebraska
United States Marietta Memorial Hospital Marietta Ohio
United States Arizona Arthritis & Rheumatology Associates, P. C. Mesa Arizona
United States New Horizon Research Center Miami Florida
United States Suncoast Research Group Miami Florida
United States Paramount Medical Research & Consulting, LLC Middleburg Heights Ohio
United States Suncoast Clinical Research, Inc. New Port Richey Florida
United States Health Research of Oklahoma Oklahoma City Oklahoma
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States Westroads Clinical Research, Inc. Omaha Nebraska
United States Hope Research Institute Peoria Arizona
United States Hope Research Institute Peoria Arizona
United States IRIS Research and Development, LLC Plantation Florida
United States Desert Medical Advances Rancho Mirage California
United States Regional Health Clinical Research Rapid City South Dakota
United States Allied Clinical Research Reno Nevada
United States StudyMetrix Research Saint Peters Missouri
United States PMG Research of Salisbury, LLC Salisbury North Carolina
United States Accurate Clinical Research, Inc. San Antonio Texas
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Rheumatology Center of San Diego San Diego California
United States East Bay Rheumatology Medical Group, Inc San Leandro California
United States Santa Fe Rheumatology Santa Fe New Mexico
United States The Rheumatology Group South Charleston West Virginia
United States Qps-Mra, Llc South Miami Florida
United States Arthritis Northwest, PLLC Spokane Washington
United States Clinvest Research LLC Springfield Missouri
United States Stamford Therapeutics Consortium Stamford Connecticut
United States Accurate Clinical Management Sugar Land Texas
United States ForCare Clinical Research Tampa Florida
United States Dynamed Clinical Research, LP d/b/a DM Clinical Research Tomball Texas
United States Arizona Arthritis & Rheumatology Research, PLLC Tucson Arizona
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 The Vancouver Clinic Vancouver Washington
United States The Center for Rheumatology and Bone Research Wheaton Maryland
United States Medvin Clinical Research - Su Whittier California
United States Alliance for Multispecialty Research, LLC Wichita Kansas
United States PMG Research of Wilmington Wilmington North Carolina
United States Clinical Research Center of Reading,LLC Wyomissing Pennsylvania
United States Pennsylvania Regional Center for Arthritis and Osteoporosis Research Wyomissing Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Lithuania,  Netherlands,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) Time from First Dose of Study Treatment to First ATE Baseline through Study Completion (Approximately 5.5 Years)
Secondary Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) Time from First Dose of Study Treatment to First MACE Baseline through Study Completion (Approximately 5.5 Years)
Secondary Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC]) Time from First Dose of Study Treatment to First Malignancy (excluding NMSC) Baseline through Study Completion (Approximately 5.5 Years)
Secondary Time from First Dose of Study Treatment to First Opportunistic Infection Time from First Dose of Study Treatment to First Opportunistic Infection Baseline through Study Completion (Approximately 5.5 Years)
Secondary Time from First Dose of Study Treatment to First Serious Infection Time from First Dose of Study Treatment to First Serious Infection Baseline through Study Completion (Approximately 5.5 Years)
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