Lipids, Inflammation, and CV Risk in RA

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02714881

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Cardiovascular Disease	Drug: certolizumab Radiation: Stress myocardial perfusion PET	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

May 18, 2021

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Tumor necrosis factor inhibitor 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 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. Other Names: Cimzia 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. Other Names: Cardiac PET

Arm

Intervention/Treatment

Other: Tumor necrosis factor inhibitor

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

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.

Other Names:

Cimzia

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.

Other Names:

Cardiac PET

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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)