BENITIONSClinical Trial Intelligence

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

Phase 4 Completed NCT03915964

ConditionRheumatoid Arthritis
PhasePhase 4
SponsorEli Lilly and Company
StatusCompleted
Enrollment2,659 participants
InterventionsBaricitinib, TNF Inhibitor
Start dateApr 25, 2019
Completion dateMay 28, 2025
Results postedJun 24, 2026

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.

Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]

From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants) · Days

Baricitinib 2/4 mgNA Days
TNF InhibitorNA Days
Hazard Ratio (HR)1.606 (95% CI 0.969–2.660)

Open in BENITIONS View on ClinicalTrials.gov

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