For Healthcare Professionals

A Study of Baricitinib in Participants With Rheumatoid Arthritis

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About the study

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 (RA).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

* Participants must have at least one of the following characteristics:

  1. Documented evidence of a VTE prior to this study
  2. At least 60 years of age
  3. A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
  4. Age 50 to less than 60 years and BMI 25 to less than 30 kg/m²
  5. Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic)

EXCLUSION CRITERIA

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:

  1. discontinued for IR (lack or loss of efficacy) for RA, or
  2. discontinued for intolerance (AE) when used for any indication
  3. Participants must not be pregnant or breastfeeding
  4. Participants must not have had more than one VTE
  5. Participants must not have cancer
  6. Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness
  7. Participants must not have had a live vaccine within four weeks of study start
  8. Participants must not have participated in any other clinical trial within four weeks of study start
  9. Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-317-615-4559Email iconEmail Study Center

Study Details


Contition

Rheumatoid Arthritis

Age

18+

Phase

PHASE4

Participants Needed

1300

Est. Completion Date

Feb 1, 2026

Treatment Type

INTERVENTIONAL


Sponsor

Eli Lilly and Company

ClinicalTrials.gov NCT Identifier

NCT04086745

Study Number

I4V-MC-JAJD

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