A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03915964

Run by

Eli Lilly and Company

People needed

2659

Starts

2019-04-25

Expected to finish

2025-05-28

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 drug (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.

Where it is running

• Arthrocare, Arthritiscare & Research PC — Gilbert, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
• Hope Research Institute — Peoria, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Tucson, Arizona, United States
• Medvin Clinical Research - Covina — Covina, California, United States
• St Joseph Heritage Healthcare — Fullerton, California, United States
• Christine Thai, MD — Huntington Beach, California, United States
• Private Practice - Dr. Christine J. Leehealey — Irvine, California, United States
• Desert Medical Advances — Rancho Mirage, California, United States
• Rheumatology Center of San Diego — San Diego, California, United States
• East Bay Rheumatology Medical Group, Inc — San Leandro, California, 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
• Medvin Clinical Research - Whittier — Whittier, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Rheumatology Associates of South Florida — Boca Raton, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• IRIS Research and Development, LLC — Plantation, Florida, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Flagstaff, Arizona, United States

Full record on ClinicalTrials.gov

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