A Study of Baricitinib in Participants With Rheumatoid Arthritis
Launched by ELI LILLY AND COMPANY · Sep 10, 2019
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called baricitinib to see how safe it is compared to another type of treatment for rheumatoid arthritis (RA) known as TNF inhibitors. Specifically, the researchers want to find out if using baricitinib leads to fewer serious blood clots in the lungs or legs, known as venous thromboembolic events (VTEs). The study is currently looking for participants who are 60 years or older, or who are between 50 and 60 years old with certain weight conditions, and who have not had success with other RA medications.
To participate, individuals must have a history of VTE, or be at least 60 years old, or meet specific weight criteria. They should also have not responded well to at least one other RA medication. It’s important to note that individuals who are pregnant, have certain serious health conditions, or have recently participated in other clinical trials may not be eligible. Those who join the study can expect to receive either baricitinib or a TNF inhibitor and will be monitored for their health throughout the trial. This research is important for understanding how to better manage rheumatoid arthritis while keeping patients safe.
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 must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:
- • discontinued for IR (lack or loss of efficacy) for RA, or
- • discontinued for intolerance (AE) when used for any indication
- • 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
New Orleans, Louisiana, United States
Lebanon, New Hampshire, United States
Chicago, Illinois, United States
Duncansville, Pennsylvania, United States
Rancho Mirage, California, United States
Orlando, Florida, United States
Burbank, California, United States
Tampa, Florida, United States
Amarillo, Texas, United States
Glendale, Wisconsin, United States
Palm Desert, California, United States
Dallas, Texas, United States
Bowling Green, Kentucky, United States
Philadelphia, Pennsylvania, United States
Rockford, Illinois, United States
Spokane, Washington, United States
Jefferson City, Missouri, United States
Dallas, Texas, United States
Beckley, West Virginia, United States
Rockford, Illinois, United States
Jackson, Tennessee, United States
Peoria, Arizona, United States
Gainesville, Georgia, United States
Beckley, West Virginia, United States
Middleburg Heights, Ohio, United States
Hickory, North Carolina, United States
Atlanta, Georgia, United States
Wilmington, North Carolina, United States
Danbury, Connecticut, United States
Houston, Texas, United States
Atlanta, Georgia, United States
Lewes, Delaware, United States
Upland, California, United States
Tamarac, Florida, United States
Corvallis, Oregon, United States
Cumberland, Maryland, United States
Hagerstown, Maryland, United States
Wyomissing, Pennsylvania, United States
Monroe, Louisiana, United States
Phoenix, Arizona, United States
Chesapeake, Virginia, United States
Greensboro, North Carolina, United States
Leland, North Carolina, United States
Houston, Texas, United States
Mesa, Arizona, United States
Tamarac, Florida, United States
Cypress, Texas, United States
League City, Texas, United States
Philadelphia, Pennsylvania, United States
Oklahoma City, Oklahoma, United States
Beverly Hills, California, United States
Temple, Texas, United States
New York, New York, United States
Marion, Ohio, United States
San Antonio, Texas, United States
La Mesa, California, United States
La Mesa, California, United States
Tustin, California, United States
Toms River, New Jersey, United States
Rapid City, South Dakota, United States
Rockford, Illinois, United States
Glendale, Arizona, United States
North Charleston, South Carolina, United States
Murray, Utah, United States
Boise, Idaho, United States
Mesquite, Texas, United States
Allen, Texas, United States
Reno, Nevada, United States
Minot, North Dakota, United States
West Hills, California, United States
Canoga Park, California, United States
Fall River, Massachusetts, United States
Plantation, Florida, United States
Houston, Texas, United States
Summerville, South Carolina, United States
Beverly Hills, California, United States
South Bend, Indiana, United States
Whittier, California, United States
Temple, Texas, United States
Durham, North Carolina, United States
Zephyrhills, Florida, United States
Poway, California, United States
Margate, Florida, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Baytown, Texas, United States
Danville, Virginia, United States
Tucson, Arizona, United States
Lake Charles, Louisiana, United States
Springfield, Missouri, United States
Fullerton, California, United States
New York, New York, United States
Flagstaff, Arizona, United States
Mesa, Arizona, United States
Huntington Beach, California, United States
San Leandro, California, United States
Tujunga, California, United States
Rapid City, South Dakota, United States
College Station, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Greensboro, North Carolina, United States
Tampa, Florida, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Jonesboro, Arkansas, United States
Covina, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
San Diego, California, United States
Debary, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Riverview, Florida, United States
Saint Petersburg, Florida, United States
Hinsdale, Illinois, United States
Schaumburg, Illinois, United States
Skokie, Illinois, United States
Hopkinsville, Kentucky, United States
Baton Rouge, Louisiana, United States
Grand Blanc, Michigan, United States
Okemos, Michigan, United States
Saint Louis, Missouri, United States
Somerset, New Jersey, United States
West Long Branch, New Jersey, United States
Wexford, Pennsylvania, United States
Crossville, Tennessee, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
Plano, Texas, United States
Sugar Land, Texas, United States
Sugar Land, Texas, United States
The Woodlands, Texas, United States
Manassas, Virginia, United States
Newport News, Virginia, United States
Springfield, Missouri, United States
Red Oak, Texas, United States
Santa Rosa, California, United States
Miami, Florida, United States
Milwaukee, Wisconsin, United States
Brooklyn, New York, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Mansfield, Texas, United States
Katy, Texas, United States
Doral, Florida, United States
Doral, Florida, United States
Chandler, Arizona, United States
Monterey Park, California, United States
Lake Worth, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pearland, Texas, United States
Pleasanton, Texas, United States
Gainesville, Florida, United States
Flagstaff, Arizona, United States
Springfield, Missouri, United States
Houston, Texas, United States
Houston, Texas, United States
Chandler, Arizona, United States
Paradise Valley, Arizona, United States
El Cajon, California, United States
San Diego, California, United States
Lake Worth, Florida, United States
Henderson, Nevada, United States
Toms River, New Jersey, United States
Cranberry Township, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Los Alamitos, California, United States
Nashville, Tennessee, United States
Katy, Texas, United States
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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