IRIS Research and Development | Plantation, FL
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About
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).
Enrollment
Sex
Ages
Volunteers
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 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:
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
Primary purpose
Allocation
Interventional model
Masking
1,300 participants in 3 patient groups
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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