Rheumatoid Arthritis, Cardiovascular Disease
Conditions
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.
Interventions
DRUGCertolizumab
Sponsors
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Flow Reserve | 24 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine P Liao, MD, MPH
Brigham and Women's Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 23 / 74 |
| serious Total, serious adverse events | 2 / 74 |
Outcome results
None listed