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Search / Trial NCT04086745

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.

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

0 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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