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
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Cardiovascular Disease||Drug: certolizumab Radiation: Stress myocardial perfusion PET||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||March 2021|
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.
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714881
|Contact: Katherine P Liao, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|