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

CompletedPhase 4

Sponsor: Eli Lilly and Company

Conditions: Rheumatoid Arthritis

Interventions: Baricitinib, TNF Inhibitor

Countries: United States, Australia, Austria, Belgium, Czechia, Denmark, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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/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).

Exclusion Criteria:

* 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.

Locations (261)

Flagstaff, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Covina, California, United States
Fullerton, California, United States
Huntington Beach, California, United States
Irvine, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
San Leandro, California, United States
Tujunga, California, United States
Tustin, California, United States
Upland, California, United States
Van Nuys, California, United States
Whittier, California, United States
Stamford, Connecticut, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Plantation, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Gainesville, Georgia, United States
Boise, Idaho, United States
+ 231 more on CT.gov