Lipids, Inflammation, and CV Risk in RA

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-17

Study Completion Date

2022-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis Cardiovascular Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Tumor necrosis factor inhibitor

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.

Certolizumab

Intervention Type DRUG

Interventions

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Certolizumab

Intervention Type DRUG

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)

Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No