Lipids, Inflammation, and CV Risk in RA (LiiRA)

December 31, 2025 updated by: Katherine P Liao, Brigham and Women's Hospital

Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis

The objective of this study was to examine the relationship between inflammation, lipids, and cardiovascular risk in rheumatoid arthritis. The central hypothesis is that reducing inflammation will reduce cardiovascular risk as measured by coronary flow reserve. Additionally, we hypothesized that lipid levels may have a weaker correlation with CV risk compared to the general population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with active RA who are biologic naive

Description

Inclusion Criteria:

  • RA diagnosed by a rheumatologist
  • Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
  • Age>35
  • Active RA as defined by treating rheumatologist
  • Biologic DMARD naive

Exclusion Criteria:

  • Patients on statin or PCSK9 inhibitor therapy
  • Corticosteroid therapy >10mg prednisone or its equivalent as a maintenance treatment
  • Pregnancy
  • Unstable angina (chest pain) or shortness of breath
  • Severe valvular heart disease
  • Myocarditis
  • Pericarditis
  • Asthma with active wheezing
  • History of lymphoproliferative disease or melanoma (stage two or higher), active malignancy, or cancer treatment in the last 5 years
  • Active infectious disease (HIV, Tuberculosis, or Hepatitis B/C)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tumor necrosis factor inhibitor
Subjects who are about to initiate a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. Subjects will undergo measurements for inflammatory biomarkers, lipids and advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Drug: Certolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary Flow Reserve
Time Frame: 24 weeks
The coronary flow reserve (CFR) is the ratio of myocardial blood flow at stress over myocardial blood flow at rest. This marker is ideally suited as the cardiac imaging biomarker for both a measure of coronary vasomotor function as well as surrogate CV outcome in RA.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Katherine P Liao, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2016

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimated)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000219
  • R01HL127118 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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