A Study of Baricitinib in Participants With Rheumatoid Arthritis

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT04086745

Run by

Eli Lilly and Company

People needed

1050

Starts

2020-02-14

Expected to finish

2025-05-19

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis & Rheumatology Associates, P. C. — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research — Paradise Valley, Arizona, United States
• Sun Valley Arthritis Center, LTD — Peoria, Arizona, United States
• Arizona Arthritis & Rheumatology Associates — Phoenix, Arizona, United States
• Arthritis and Rheumatism Associates — Jonesboro, Arkansas, United States
• Providence St. Joseph's Medical Center — Burbank, California, United States
• Hope Clinical Research, Inc. — Canoga Park, California, United States
• Medvin Clinical Research - Covina — Covina, California, United States
• TriWest Research Associates LLC — El Cajon, California, United States
• Newport Huntington Med Grp — Huntington Beach, California, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• Valerius Medical Group and Research Center of Greater Long Beach — Los Alamitos, California, United States
• R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center — Monterey Park, California, United States
• ACRC Studies — Poway, California, United States
• Desert Medical Advances — Rancho Mirage, California, United States
• Purushotham & Akther Kotha MD Inc — San Diego, California, United States
• East Bay Rheumatology Medical Group, Inc — San Leandro, California, United States
• Providence Medical Foundation — Santa Rosa, California, United States
• Dan La, MD Inc — Tujunga, California, United States
• Office: Dr Robin K Dore — Tustin, California, United States
• Inland Rheumatology & Osteoporosis Medical Group — Upland, California, United States
• Nazanin Firooz, MD Inc. — West Hills, California, United States
• Medvin Clinical Research - Whittier — Whittier, California, United States
• Danbury Clinical Research, LLC — Danbury, Connecticut, United States
• Arizona Research Clinic PLLC — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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