A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
Phase 4
Completed
NCT03915964
| Condition | Rheumatoid Arthritis |
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| Phase | Phase 4 |
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| Sponsor | Eli Lilly and Company |
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| Status | Completed |
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| Enrollment | 2,659 participants |
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| Interventions | Baricitinib, TNF Inhibitor |
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| Start date | Apr 25, 2019 |
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| Completion date | May 28, 2025 |
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| Results posted | Jun 24, 2026 |
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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 mg | NA Days |
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| TNF Inhibitor | NA Days |
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| Hazard Ratio (HR) | 1.606 (95% CI 0.969–2.660) |
Open in BENITIONS
View on ClinicalTrials.gov
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