The aim of this clinical trial is to determine the connection between inflammation, lipids (fats), and cardiovascular disease in rheumatoid arthritis. The main outcome to be measured is the rate of blood flow through the heart before and after treatment with certolizumab (Cimzia).
The details
Cardiovascular (CV) risk is known to be increased in patients with rheumatoid arthritis (RA). Cardiovascular risks include strokes, heart attacks and heart failure. It is believed that inflammation in RA is linked to increased levels of fat and harmful cholesterol which can build up in the arteries and cause CV complications. Anti-TNF drugs such as certolizumab are a type of biological treatment used for RA to reduce inflammation.
Coronary flow reserve (CFR) is the measurement of the blood flow through the arteries. A lower CFR is associated with increased CV risk. This study will look at changes in CFR before and after treatment with certolizumab.
Who are they looking for?
This trial will recruit 75 patients over the age of 35 with active RA. Participant who are about to start anti-TNF therapy as part of their treatment will be included. Patients must not have had any previous treatment with biological drugs.
Patients must not have taken statins or the cholesterol lowering drug PCSK9 inhibitors. Patients must not currently have angina, heart disease, myocarditis or pericarditis (inflammation of the heart wall) or asthma. Particpants should not have received cancer treatment in the last 5 years.
How will it work
Patients who are about to begin anti-TNF therapy will be prescribed certolizumab at the start of this study. The study will run for 24 weeks. Routine lipids, advanced lipoproteins and CFR will be measured before and after treatment to determine the specific cholesterol levels and cardiovascular risk in all participants.
