Lipids, Inflammation, and CV Risk in RA

NCT02714881 | Completed Results FDA Drug

• 2 other identifiers: 2016P000219R01HL127118
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Coronary Flow Reserve

  The coronary flow reserve (CFR) is the ratio of myocardial blood flow at stress over myocardial blood flow at rest. This marker is ideally suited as the cardiac imaging biomarker for both a measure of coronary vasomotor function as well as surrogate CV outcome in RA.

  24 weeks

Study Arms (1)

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.

Drug: Certolizumab

Interventions

Certolizumab DRUG

Tumor necrosis factor inhibitor

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active RA who are biologic naive

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Weber B, Weisenfeld D, Massarotti E, Seyok T, Cremone G, Lam E, Golnik C, Brownmiller S, Liu F, Huang S, Todd DJ, Coblyn JS, Weinblatt ME, Cai T, Dahal K, Kohler M, Yinh J, Barrett L, Solomon DH, Plutzky J, Schelbert HR, Campisi R, Bolster MB, Di Carli M, Liao KP. Interplay Between Systemic Inflammation, Myocardial Injury, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis: Results From the LiiRA Study. J Am Heart Assoc. 2024 May 7;13(9):e030387. doi: 10.1161/JAHA.123.030387. Epub 2024 Apr 30.

  PMID: 38686879 DERIVED

• Weber B, Weisenfeld D, Seyok T, Huang S, Massarotti E, Barrett L, Bibbo C, Solomon DH, Plutzky J, Bolster M, Di Carli M, Liao KP. Relationship Between Risk of Atherosclerotic Cardiovascular Disease, Inflammation, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis. J Am Heart Assoc. 2022 Jun 7;11(11):e025467. doi: 10.1161/JAHA.121.025467. Epub 2022 Jun 3. No abstract available.

  PMID: 35657008 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Cardiovascular Diseases

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Katherine P. Liao, MD, MPH
• Organization: Brigham and Women's Hospital

kliao@bwh.harvard.edu

617-732-5000

Study Officials

• Katherine P Liao, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 22, 2016
• Study Start: October 17, 2016
• Primary Completion: December 14, 2020
• Study Completion: December 21, 2022
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-12

Locations

US (1)