Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lipids, Inflammation, and CV Risk in RA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714881
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine P Liao, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date July 10, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
coronary flow reserve (CFR) measured by cardiac PET [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipids, Inflammation, and CV Risk in RA
Official Title  ICMJE Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Rheumatoid Arthritis
  • Cardiovascular Disease
Intervention  ICMJE
  • 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 Name: 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 Name: Cardiac PET
Study Arms  ICMJE 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.
Interventions:
  • Drug: certolizumab
  • Radiation: Stress myocardial perfusion PET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2016)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine P Liao, MD, MPH 617-525-8819 kliao@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714881
Other Study ID Numbers  ICMJE 2016P000219
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Katherine P Liao, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP