Lipids, Inflammation, and CV Risk in RA

Study Overview
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Brief Summary
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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.

Official Title
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Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis, Cardiovascular Disease

Intervention / Treatment
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* Drug: certolizumab
* Radiation: Stress myocardial perfusion PET


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tumor necrosis factor inhibitor<br>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. | Drug: certolizumab<br>* 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.<br>* Other names: Cimzia;Radiation: Stress myocardial perfusion PET<br>* We will measure coronary flow reserve (CFR) using cardiac PET before the patients starts TNFi and 24 weeks after starting TNFi.<br>* Other names: Cardiac PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |