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

• Status: Active, not recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Incyte Corporation
• Treatments: Adalimumab; Etanercept; Tumor Necrosis Factor Inhibitors

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.