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A Study of Baricitinib in Participants With Rheumatoid Arthritis

CompletedPhase 4

Sponsor: Eli Lilly and Company

Conditions: Rheumatoid Arthritis

Interventions: Baricitinib, TNF Inhibitor

Countries: United States

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).

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 must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:

  * discontinued for 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

Locations (119)

Chandler, Arizona, United States
Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Jonesboro, Arkansas, United States
Burbank, California, United States
Canoga Park, California, United States
Covina, California, United States
El Cajon, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Los Alamitos, California, United States
Monterey Park, California, United States
Poway, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
San Leandro, California, United States
Santa Rosa, California, United States
Tujunga, California, United States
Tustin, California, United States
Upland, California, United States
West Hills, California, United States
Whittier, California, United States
Danbury, Connecticut, United States
Lewes, Delaware, United States
DeBary, Florida, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
+ 89 more on CT.gov