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Lipids, Inflammation, and CV Risk in RA

Primary Purpose

Rheumatoid Arthritis, Cardiovascular Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
certolizumab
Stress myocardial perfusion PET
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tumor necrosis factor inhibitor

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2016
Last Updated
July 25, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02714881
Brief Title
Lipids, Inflammation, and CV Risk in RA
Official Title
Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Cardiovascular Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumor necrosis factor inhibitor
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
certolizumab
Other Intervention Name(s)
Cimzia
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stress myocardial perfusion PET
Other Intervention Name(s)
Cardiac PET
Intervention Description
We will measure coronary flow reserve (CFR) using cardiac PET before the patients starts TNFi and 24 weeks after starting TNFi.
Primary Outcome Measure Information:
Title
coronary flow reserve (CFR) measured by cardiac PET
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine P Liao, MD, MPH
Phone
617-525-8819
Email
kliao@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine P Liao, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35657008
Citation
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.
Results Reference
derived
Links:
URL
http://liira.org
Description
LiiRA Website

Learn more about this trial

Lipids, Inflammation, and CV Risk in RA

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