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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 drugs (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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03915964
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Baricitinib Low Dose

Baricitinib administered orally.

Experimental: Baricitinib High Dose

Baricitinib administered orally.

Active Comparator: TNF Inhibitor

Adalimumab or etanercept administered subcutaneously (SC) per standard of care.

Interventions

Drug: - Baricitinib

Administered orally.

Drug: - TNF Inhibitor

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Flagstaff, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Flagstaff, Arizona, 86001

Site Contact

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