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

Mass General Brigham

Status: Completed

Conditions: Cardiovascular Disease; Rheumatoid Arthritis

Treatments: Drug: Certolizumab

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02714881

2016P000219

R01HL127118 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

74 participants in 1 patient group

Tumor necrosis factor inhibitor

Description:

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.

Treatment:

Drug: Certolizumab