A Randomized Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis

Brief description of study

The purpose of this research study is to help determine the safety of a drug called baricitinib. Baricitinib is a type of medicine called a Janus kinase (JAK) inhibitor. Baricitinib has been approved at a 2 mg dose by the United States Food and Drug Administration (FDA) for treatment of moderately to severely active RA. This study is also looking at a higher dose (4 mg) of baricitinib that is not approved by the FDA. The study is comparing the safety of both doses of baricitinib to the standard of care drugs, Humira® and Enbrel®. Both Humira® and Enbrel® are FDA approved to treat moderate to severe active RA and will be used in this study at the approved dose. The study will compare the safety of the study drugs by reviewing health events that happen during the study. The main health event to be reviewed is clots that occur in a vein (called venous thromboembolism or "VTE"). Other health events being reviewed are blood clots in arteries, major cardiac (heart) events, cancers, and infections.

Clinical Study Identifier: s20-00001
ClinicalTrials.gov Identifier: NCT04086745
Principal Investigator: David H. Goddard.

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