Lipids, Inflammation, and CV Risk in RA

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Cardiovascular Disease
• Interventions: Drug: certolizumab; Radiation: Stress myocardial perfusion PET

• Registration Number: NCT02714881
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-22
• Study Start: 2016-04
• Primary Completion: 2021-05-18
• Study Completion: 2023-08-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor necrosis factor inhibitor	Stress myocardial perfusion PET	Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Tumor necrosis factor inhibitor	certolizumab	Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.

Primary Outcome Measures

Name	Time	Method
coronary flow reserve (CFR) measured by cardiac PET	24 weeks	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States