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Comparing Baricitinib and TNF Inhibitors for Rheumatoid Arthritis

A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

PHASE4 · Eli Lilly and Company · NCT04086745

This study is testing whether baricitinib is safer than TNF inhibitors for people with rheumatoid arthritis by looking at the risk of blood clots.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment1300 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company (industry)
Drugs / interventionsbaricitinib
Locations139 sites (Chandler, Arizona and 138 other locations)
Trial IDNCT04086745 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety of baricitinib compared to tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis, specifically focusing on the occurrence of venous thromboembolic events (VTEs). It is a post-marketing phase 4 trial that aims to gather real-world data on the risks associated with these treatments. Participants will be selected based on specific criteria, including age, body mass index, and prior treatment responses. The study will help determine the relative safety profiles of these two treatment options for rheumatoid arthritis.

Who should consider this trial

Good fit: Ideal candidates include individuals with rheumatoid arthritis who have experienced inadequate response or intolerance to previous DMARDs and meet specific age and BMI criteria.

Not a fit: Patients who have previously used a Janus kinase (JAK) inhibitor or have had more than one VTE may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into safer treatment options for patients with rheumatoid arthritis, particularly those at risk for VTEs.

How similar studies have performed: Other studies have explored the safety of baricitinib and TNF inhibitors, but this specific comparison regarding VTEs is novel.

Eligibility criteria

Show full inclusion / exclusion 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 must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:

  * discontinued for IR (lack or loss of efficacy) for RA, or
  * discontinued for intolerance (AE) when used for any indication
* 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

Where this trial is running

Chandler, Arizona and 138 other locations

+89 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Rheumatoid Arthritis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.