A Study of Baricitinib in Participants With Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1300
  • sponsor
    Eli Lilly and Company
Updated on 22 September 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
PMG Research of Hickory, LLC (5.1 mi away) Contact
+170 other location
body mass index
tumor necrosis factor
DMARD
tumor necrosis factor alpha
tumour necrosis
baricitinib
antirheumatics

Summary

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).

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment Baricitinib, TNF Inhibitor
Clinical Study IdentifierNCT04086745
SponsorEli Lilly and Company
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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/m), or
Age 50 to less than 60 years and BMI 25 to less than 30 kg/m
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
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