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NCT03915964 · ClinicalTrials.gov registry record · Phase 4
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,659
- Enrollment target
NCT03915964: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT03915964 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 2,659 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (413% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03915964, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,659 participants
- Enrollment target
Study 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.
Primary Outcome
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographi
Interventions
- DRUG Baricitinib
- DRUG TNF Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,659 participants |
| Start Date | 2019-04-25 |
| Est. Completion | 2025-05-28 |
| Phase | Phase 4 |
What the finished NCT03915964 record still lists
NCT03915964 is an interventional study that assigns participants to a tested intervention. Its 2,659 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (413% higher).
The record links to 0 conditions, and to 2 interventions - of which Baricitinib is the first listed.
NCT03915964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03915964 about?
NCT03915964 is a clinical study titled "A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis". 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.
What is the current status of trial NCT03915964?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,659 participants. The study started on 2019-04-25. Estimated completion is 2025-05-28.
What interventions are being tested in trial NCT03915964?
The interventions under investigation include: Baricitinib (DRUG), TNF Inhibitor (DRUG).
Who is sponsoring clinical trial NCT03915964?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03915964's enrollment target sits among peer trials
2,659 27th of 2000 higher than 1,974 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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