CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,659 enrolled / 2,659 target
Drug / intervention
Baricitinib +1 moredrug
Likely dose
2 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03915964
NCT03915964Phase 4CompletedMonitor (30.8/mo)Completion was 13mo ago
CompareCT.gov

A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Eli Lilly and Company·interventional·Posted Apr 16, 2019·Updated Jun 24, 2026

In Brief

A Phase 4 clinical trial evaluating Baricitinib and TNF Inhibitor for Rheumatoid Arthritis. Completed, enrolled 2,659 participants across 261 sites in 24 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
CollaboratorsIncyte Corporation

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartApr 25, 2019
Primary CompletionMay 28, 2025
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 7.2 years ago

Arms & Interventions

Baricitinib 2mgexperimental

Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2mg could receive rescue treatment with baricitinib 4mg.

Drug: Baricitinib
Baricitinib 4mgexperimental

Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.

Drug: Baricitinib
Tumor Necrosis Factor (TNF) Inhibitoractive_comparator

Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.

Drug: TNF Inhibitor

Interventions

Baricitinibdrug

Administered orally.

TNF Inhibitordrug

Administered subcutaneously.