Lipids, Inflammation, and CV Risk in RA

Rheumatoid Arthritis Clinical Trial

Official title:

Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714881
• Other study ID #: 2016P000219
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 11, 2023

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to elucidate the relationship between inflammation and lipoprotein atherogenicity, and to determine the relative contribution of inflammation and lipids to CV risk in RA. The central hypothesis of this study is that inflammation and lipoprotein atherogenicity is tightly linked such that both factors are important to assess CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a consideration of routine lipids alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 11, 2023
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Cardiovascular Disease
• Cardiovascular Diseases
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• certolizumab
Subjects who are about to start TNFi therapy as part of usual therapy will be enrolled. In this study we will provide the drug, certolizumab.

Radiation:
• Stress myocardial perfusion PET
We will measure coronary flow reserve (CFR) using cardiac PET before the patients starts TNFi and 24 weeks after starting TNFi.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coronary flow reserve (CFR) measured by cardiac PET	The investigators will compare the CFR of subjects before baseline with their CFR after 24 weeks on TNFi. Each subject serves as their own control.	24 weeks

External Links

•   LiiRA Website