Lipids, Inflammation, and CV Risk in RA

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Certolizumab Pegol

Criteria

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)