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Completed

NCT Number: NCT02714881

Lipids, Inflammation, and CV Risk in RA

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Disease Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Certolizumab

Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis

Acronym: LiiRA

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 22, 2016
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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