A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
Launched by ELI LILLY AND COMPANY · Apr 12, 2019
Trial Information
Current as of April 25, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a medication called baricitinib to see how safe it is compared to another type of drug known as TNF inhibitors for people with rheumatoid arthritis. The main focus is to understand if using baricitinib affects the risk of blood clots in the veins, which can be a serious health concern. This study is currently active but not recruiting new participants.
To be part of this trial, individuals should be between 50 and 74 years old, have a documented history of blood clots, or have certain weight-related health concerns. They should also have not responded well to or cannot tolerate at least one other arthritis treatment. However, participants cannot be pregnant, have certain serious health conditions, or have had recent vaccinations. If eligible, participants can expect to receive careful monitoring and support throughout the study to ensure their safety and well-being.
Gender
ALL
Eligibility criteria
- 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.
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lebanon, New Hampshire, United States
Oklahoma City, Oklahoma, United States
Lebanon, New Hampshire, United States
Madrid, , Spain
Madrid, , Spain
Pretoria, , South Africa
Columbus, Ohio, United States
Duncansville, Pennsylvania, United States
Rancho Mirage, California, United States
Haifa, , Israel
Barcelona, , Spain
Elizabethtown, Kentucky, United States
Marietta, Ohio, United States
Wheaton, Maryland, United States
Palm Desert, California, United States
Hull, , United Kingdom
Oklahoma City, Oklahoma, United States
Elche, Alicante, Spain
Brussels, , Belgium
Cordoba, , Spain
New Port Richey, Florida, United States
Sevilla, , Spain
Wolverhampton, , United Kingdom
Stamford, Connecticut, United States
Spokane, Washington, United States
Bethlehem, Pennsylvania, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Vigo, Pontevedra, Spain
Naples, Florida, United States
Boise, Idaho, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Praha 4, , Czechia
Praha 4, , Czechia
San Juan, , Puerto Rico
Elche, Alicante, Spain
Gainesville, Georgia, United States
Middleburg Heights, Ohio, United States
Albuquerque, New Mexico, United States
Atlanta, Georgia, United States
San Antonio, Texas, United States
Wilmington, North Carolina, United States
Torino, , Italy
Torquay, Devon, United Kingdom
Köln, Nordrhein Westfalen, Germany
Vancouver, Washington, United States
Hull, East Yorkshire, United Kingdom
Grand Rapids, Michigan, United States
Bloemfontein, Free State, South Africa
Rapid City, South Dakota, United States
Amsterdam, , Netherlands
Majadahonda, Madrid, Spain
Tula, , Russian Federation
Maroochydore, Queensland, Australia
Upland, California, United States
Portsmouth, Hampshire, United Kingdom
Albuquerque, New Mexico, United States
Getafe, Madrid, Spain
Charlotte, North Carolina, United States
Salisbury, North Carolina, United States
Plymouth, Devon, United Kingdom
Firenze, , Italy
Fribourg, , Switzerland
Gdansk, Pomorskie, Poland
Phoenix, Arizona, United States
Hull, East Yorkshire, United Kingdom
Lansing, Michigan, United States
Kalispell, Montana, United States
Wyomissing, Pennsylvania, United States
Ryazan, , Russian Federation
Miami, Florida, United States
Middleburg Heights, Ohio, United States
Tel Aviv, , Israel
Debrecen, , Hungary
Sydney, New South Wales, Australia
Kfar Saba, , Israel
Istanbul, , Turkey
Maroochydore, Queensland, Australia
Chelmsford, Essex, United Kingdom
Stellenbosch, , South Africa
Hobart, Tasmania, Australia
Camberwell, Victoria, Australia
Sheffield, , United Kingdom
Houston, Texas, United States
New Port Richey, Florida, United States
Nadarzyn, Mazowieckie, Poland
Wien, , Austria
Leland, North Carolina, United States
Houston, Texas, United States
Dudley, West Midlands, United Kingdom
Glendale, Arizona, United States
Wyomissing, Pennsylvania, United States
League City, Texas, United States
Merksem, Vlaams Gewest, Belgium
Genk, , Belgium
Praha 2, Praha, Hlavní Mešto, Czechia
Brno, , Czechia
Ostrava, , Czechia
Zlin, , Czechia
Würzburg, Bayern, Germany
Dresden, Sachsen, Germany
Kifissia, Attiki, Greece
Budapest, Pest, Hungary
Ashkelon, Hadarom, Israel
Haifa, ḥeifā, Israel
Kaunas, , Lithuania
Siauliai, , Lithuania
Katowice, , Poland
Warszawa, , Poland
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Saint Petersburg, Leningradskaya Oblast', Russian Federation
Ul'yanovsk, Ul'yanovskaya Oblast, Russian Federation
Moscow, , Russian Federation
Partizanske, , Slovakia
Spisska Nova Ves, , Slovakia
Topolcany, , Slovakia
Port Elizabeth, Eastern Cape, South Africa
Durban, Kz Natal, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
London, Surrey, United Kingdom
Newcastle Upon Tyne, Tyneside, United Kingdom
Konya, , Turkey
Tel Aviv, , Israel
Alexandroupolis, , Greece
Wien, , Austria
Chicago, Illinois, United States
Edirne, , Turkey
Wolverhampton, West Midlands, United Kingdom
San Antonio, Texas, United States
Liverpool, , United Kingdom
Paris, , France
Chieti, , Italy
Fullerton, California, United States
Saint Peters, Missouri, United States
Mesa, Arizona, United States
Boca Raton, Florida, United States
Frankfurt Am Main, Hessen, Germany
Caluire Et Cuire, , France
Eskisehir, , Turkey
Truro, England, United Kingdom
South Miami, Florida, United States
Budapest, , Hungary
Caluire Et Cuire, , France
Poznan, , Poland
Wichita, Kansas, United States
Freiburg Im Breisgau, Baden Württemberg, Germany
Boise, Idaho, United States
Oklahoma City, Oklahoma, United States
Nice, Alpes Maritimes, France
Tampa, Florida, United States
Reno, Nevada, United States
Praha 4 Nusle, , Czechia
Cincinnati, Ohio, United States
South Charleston, West Virginia, United States
Liege, , Belgium
Fullerton, California, United States
Ankara, , Turkey
Nowa Sol, , Poland
Fall River, Massachusetts, United States
Plantation, Florida, United States
Houston, Texas, United States
Moscow, , Russian Federation
Wichita, Kansas, United States
San Diego, California, United States
Bad Doberan, Mecklenburg Vorpommern, Germany
Miami, Florida, United States
A Coruña, , Spain
Peoria, Arizona, United States
Sevilla, , Spain
Whittier, California, United States
Prague, , Czechia
Evansville, Indiana, United States
Bloemfontein, Free State, South Africa
Silkeborg, Midtjylland, Denmark
Haifa, , Israel
Durham, North Carolina, United States
Bydgoszcz, Kujawsko Pomorskie, Poland
Petrozavodsk, , Russian Federation
Bucuresti, , Romania
St. Gallen, Sankt Gallen, Switzerland
Villajoyosa, Alicante, Spain
Praha, Praha 10, Czechia
Poznan, Wielkopolskie, Poland
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Whittier, California, United States
Baytown, Texas, United States
Wien, , Austria
Pardubice, , Czechia
Berlin, , Germany
Thessaloniki, , Greece
Veszprem, Veszprém City, Hungary
Leeuwarden, Fryslân, Netherlands
St.Gallen, Sankt Gallen, Switzerland
Tucson, Arizona, United States
Covina, California, United States
Nowa Sol, Lubuskie, Poland
Elblag, Warminsko Mazurki, Poland
Bucureti, , Romania
Pinelands, Western Cape, South Africa
Fuenlabrada, Madrid, Spain
Lake Charles, Louisiana, United States
Barcelona, , Spain
Springfield, Missouri, United States
Sutton In Ashfield, Nottinghamshire, United Kingdom
Wels, Oberösterreich, Austria
Fullerton, California, United States
Botany, New South Wales, Australia
Brno, , Czechia
Brasov, Brașov, Romania
Miami, Florida, United States
Ramat Gan, Hamerkaz, Israel
Flagstaff, Arizona, United States
Gilbert, Arizona, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Huntington Beach, California, United States
Irvine, California, United States
San Leandro, California, United States
Tujunga, California, United States
Tustin, California, United States
Van Nuys, California, United States
Evansville, Indiana, United States
Brighton, Michigan, United States
Santa Fe, New Mexico, United States
Hickory, North Carolina, United States
Rapid City, South Dakota, United States
College Station, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Newcastle, New South Wales, Australia
Wien, , Austria
Charleroi, Hainaut, Belgium
Brno, Brno Zidonice, Czechia
Praha 4, Czech Republic, Czechia
Uherske Hradiste, Zlínský Kraj, Czechia
Brno, , Czechia
Ostrava, , Czechia
Praha 11, , Czechia
Svendborg, , Denmark
Nice, Alpes Maritimes, France
Bordeaux, Aquitaine, France
Strasbourg, Bas Rhin, France
Toulouse, Haute Garonne, France
Limoges, Haute Vienne, France
Vendée, La Roche Sur Yon, France
Nantes, Loire Atlantique, France
Loiret, Orléans, France
Clermont Ferrand, Puy De Dôme, France
Lyon, Rhône Alpes, France
Le Mans, Sarthe, France
Amiens, , France
Caluire Et Cuire, , France
échirolles, , France
Corbeil Essonnes, île De France, France
Osnabrück, Lower Saxony, Germany
Ratingen, Nordrhein Westfalen, Germany
Magdeburg, Sachsen Anhalt, Germany
Bad Pyrmont, , Germany
Berlin, , Germany
Hamburg, , Germany
Hamburg, , Germany
Athens, Attica, Greece
Chaidari, , Greece
Miskolc, Borsod Abauj Zemplen, Hungary
Debrecen, Hajdu Bihar, Hungary
Tatabánya, Komarom Esztergom, Hungary
Haifa, ḥeifā, Israel
Rome, Lazio, Italy
Milan, Milano, Italy
Siena, Toscana, Italy
Abruzzo, , Italy
Milano, , Italy
Napoli, , Italy
Verona, , Italy
Kaunas, Kauno Miestas, Lithuania
Klaipeda, Klaipėdos Miestas, Lithuania
Vilnius, , Lithuania
Beek, Limburg, Netherlands
Rotterdam, Zuid Holland, Netherlands
Rotterdam, Zuid Holland, Netherlands
Torun, Kujawsko Pomorskie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Poznan, Wielkopolskie, Poland
Tomaszów Lubelski, , Poland
Ustron, , Poland
Warszawa, , Poland
Bytom, śląskie, Poland
Caguas, , Puerto Rico
Braila, Brăila, Romania
Iasi, Iași, Romania
Baia Mare, Maramures, Romania
Bucuresti, Sector 1, Romania
Râmnicu Vâlcea, Valcea, Romania
Galati, , Romania
Kursk, Kurskaya Oblast, Russian Federation
Moscow, Moskovskaya Oblast, Russian Federation
Moscow, Moskva, Russian Federation
Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
St. Petersburg, Sankt Peterburg, Russian Federation
Yaroslavl, Yaroslavskaya Oblast', Russian Federation
Saratov, , Russian Federation
Zvolen, Banskobystrický Kraj, Slovakia
Bratislava, Bratislavský Kraj, Slovakia
Kosice, , Slovakia
Univ Of Free State, Bloemfontein, South Africa
Kempton Park, Gauteng, South Africa
Soweto, Gauteng, South Africa
Durban, Kwazulu Natal, South Africa
Umhlanga, Kwazulu Natal, South Africa
Barcelona, Catalunya, Spain
Sabadell, Catalunya, Spain
Sant Joan Despí, Catalunya, Spain
Santiago De Compostela, La Coruna, Spain
Bilbo, País Vasco, Spain
Córdoba, , Spain
La Coruña, , Spain
Basel, Basel Stad, Switzerland
Ankara, , Turkey
İstanbul, , Turkey
Izmir, , Turkey
Truro, Cornwall, United Kingdom
Christchurch, Dorset, United Kingdom
London, Hampstead, United Kingdom
Sutton In Ashfield, Nottinghamshire, United Kingdom
Santiago De Compostela, A Coruña [La Coruña], Spain
Covina, California, United States
Houston, Texas, United States
Santiago De Compostela, Galicia [Galicia], Spain
Springfield, Missouri, United States
Chaidari, Attikí, Greece
Siena, Toscana, Italy
Chicago, Illinois, United States
Ostrava, Ostrava Město, Czechia
Napoli, , Italy
Peoria, Arizona, United States
Warszawa, Mazowieckie, Poland
Vienna, Wien, Austria
Tula, Tul'skaya Oblast', Russian Federation
Brussels, Bruxelles Capitale, Région De, Belgium
Miskolc, Borsod Abaúj Zemplén, Hungary
Ponce, , Puerto Rico
Torun, Kujawsko Pomorskie, Poland
Ryazan, Ryazanskaya Oblast', Russian Federation
Tucson, Arizona, United States
Huntington Beach, California, United States
Brno, Brno Město, Czechia
Ostrava, Moravskoslezský Kraj, Czechia
La Roche Sur Yon, Vendée, France
Tel Aviv, Tell Abīb, Israel
Barcelona, Catalunya [Cataluña], Spain
Istanbul, , Turkey
A Coruña, A Coruña [La Coruña], Spain
Strasbourg, Alsace, France
Paris, , France
Getafe, Madrid, Comunidad De, Spain
Covina, California, United States
Tomball, Texas, United States
Whittier, California, United States
Vandoeuvre Lès Nancy, Meurthe Et Moselle, France
Konya, , Turkey
Köln, Nordrhein Westfalen, Germany
A Coruña, A Coruña [La Coruña], Spain
Alexanroupolis, évros, Greece
Warszawa, Mazowieckie, Poland
Orléans, Centre, France
Konya, , Turkey
Majadahonda, Madrid, Comunidad De, Spain
Charlotte, North Carolina, United States
Bucharest, București, Romania
Eskisehir, Eskişehir, Turkey
Bordeaux, Aquitaine, France
Bad Doberan, Mecklenburg Vorpommern, Germany
Newcastle Upon Tyne, North Tyneside, United Kingdom
Chatsworth, Kwazulu Natal, South Africa
Debrecen, , Hungary
Katowice, śląskie, Poland
Hull, Kingston Upon Hull, United Kingdom
Bydgoszcz, Kujawsko Pomorskie, Poland
Warszawa, Mazowieckie, Poland
Budapest, Pest, Hungary
Budapest, , Hungary
Köln, Nordrhein Westfalen, Germany
Bucuresti, București, Romania
Moscow, Moskva, Russian Federation
Dudley, England, United Kingdom
Plymouth, Devon, United Kingdom
Warszawa, Mazowieckie, Poland
Bucharest, București, Romania
Izmir, , Turkey
Thessaloniki, Kentrikí Makedonía, Greece
Bytom, śląskie, Poland
Palm Desert, California, United States
Vienna, Wien, Austria
Praha 4, Czech Republic, Czechia
Frankfurt Am Main, Hessen, Germany
Hamburg, , Germany
Chieti, Abruzzo, Italy
Siauliai, , Lithuania
Born, Limburg, Netherlands
Bucuresti, Sector 1, Romania
Saint Petersburg, Sankt Peterburg, Russian Federation
St. Petersburg, Sankt Peterburg, Russian Federation
Moscow, , Russian Federation
Saratov, , Russian Federation
Univ Of Free State, Bloemfontein, South Africa
Pretoria, Gauteng, South Africa
Chatsworth, Kwazulu Natal, South Africa
Umhlanga, Kwazulu Natal, South Africa
Sabadell, Catalunya, Spain
Fuenlabrada, Madrid, Spain
Vigo, Pontevedra, Spain
A Coruña [La Coruña], , Spain
A Coruña, , Spain
Basel, Basel Stad, Switzerland
İstanbul, , Turkey
London, Surrey, United Kingdom
London, England, United Kingdom
South Charleston, West Virginia, United States
Genk, Limburg, Belgium
Brno, Brno Město, Czechia
Brno, Brno Město, Czechia
Brno, Jihomoravský Kraj, Czechia
Pardubice, Pardubický Kraj, Czechia
Zlin, Zlínský Kraj, Czechia
Praha 4, , Czechia
Svendborg, Syddanmark, Denmark
Frankfurt, Hessen, Germany
Alexandroupolis, évros, Greece
Tomaszów Lubelski, Lubelskie, Poland
Poznan, Wielkopolskie, Poland
Ustron, śląskie, Poland
Bucuresti, București, Romania
Moscow, Moskva, Russian Federation
Ryazan, Ryazanskaya Oblast, Russian Federation
Kosice, Košický Kraj, Slovakia
Spisska Nova Ves, Košický Kraj, Slovakia
Topolcany, Nitriansky Kraj, Slovakia
Partizanske, Trenčiansky Kraj, Slovakia
Barcelona, Catalunya [Cataluña], Spain
Barcelona, Catalunya [Cataluña], Spain
Sabadell, Catalunya [Cataluña], Spain
Sant Joan Despí, Catalunya [Cataluña], Spain
Fuenlabrada, Madrid, Comunidad De, Spain
Vigo, Pontevedra [Pontevedra], Spain
Basel, Basel Stad, Switzerland
Christchurch, Bournemouth, United Kingdom
London, Waltham Forest, United Kingdom
South Charleston, West Virginia, United States
Budapest, Pest, Hungary
Sabadell, Catalunya [Cataluña], Spain
Okemos, Michigan, United States
Houston, Texas, United States
Tustin, California, United States
Brno, Jihomoravský Kraj, Czechia
Praha, Praha 4, Czechia
Zlín, Zlínský Kraj, Czechia
Lille, , France
Haifa, ḥeifā, Israel
Siauliai, šiauliai, Lithuania
Elblag, Warmińsko Mazurskie, Poland
Galati, Galați, Romania
Baia Mare, Maramureș, Romania
Râmnicu Vâlcea, Vâlcea, Romania
Kursk, Kurskaya Oblast', Russian Federation
Moscow, Moskovskaya Oblast', Russian Federation
Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Ulianovsk, Ul'yanovskaya Oblast', Russian Federation
Yaroslavl, , Russian Federation
Cordoba, Córdoba, Spain
Basel, Basel Stadt, Switzerland
Stanbul, İstanbul, Turkey
Houston, Texas, United States
Charleston, West Virginia, United States
Poznan, Wielkopolskie, Poland
Patients applied
Trial Officials
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)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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