A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
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 (RA).
Inclusion Criteria:
Participants must have at least one of the following characteristics:
Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (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:
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
Los Alamitos, California 90720, United States
Monterey Park, California 91754, United States
Cranberry Township, Pennsylvania 15090, United States
Wyomissing, Pennsylvania 19610, United States
North Charleston, South Carolina 29406, United States
El Paso, Texas 79912, United States