TRACE RA Trial Summary
What kinds of people can take part in the TRACE RA study and how many can take part?
We are inviting people who are aged 50 years of age or older with Rheumatoid Arthritis, or people who are under 50 who have suffered from RA for 10 years or more. We hope to find around 4000 people throughout the UK who would like to take part.
Why should people with RA consider taking part in TRACE RA?
This is an important study for people with rheumatoid arthritis as there has never before been a study specifically looking at the use of statins in people with RA. Statins are commonly prescribed in the UK to help prevent heart disease: however these are mostly prescribed once a patient is deemed by their consultant or GP to have a calculated risk of developing heart disease.
We would like to find out whether taking statins will provide similar benefit to people with RA, whom we know are more likely to develop heart disease. The medical community want to avoid giving people statins unnecessarily and so the results of this study will help to inform how to treat people with RA in the future.
The study is one of the largest trials ever to be conducted in rheumatoid arthritis.
What will happen to people taking part in TRACE RA?
1st Study Visit
If you are eligible to join the study and you decide you would like to take part, your rheumatologist or nurse will examine your joints. You will be asked to complete some simple forms and questionnaires about your health and daily activities. This visit should last up to one hour. You will then be given your study tablets. You will need to take one tablet every evening.
Sometimes we don’t know if a treatment works and the only way to find out is to compare it to a placebo. A placebo is a “dummy treatment”, which looks like the genuine medicine but contains no active ingredient. Patients in this study are divided into two groups. The patients in one group are given the real treatment and the patients in the other group are given the placebo. To make sure the groups are the same, each patient is put into a group by chance (randomly). The results from the two groups are then compared.
In this study you will have a 50:50 chance of being given atorvastatin or placebo. Neither you nor your doctor will know which group you are in (However, in a medical emergency, your rheumatologist can find out what medication you have been given). Your GP will still be able to assess your risk of developing heart disease whilst you are on the trial and should they feel necessary, prescribe you with atorvastatin in addition to you taking the study medication, with the total amount at a safe, commonly prescribed dose.
2nd Study Visit
You will need to return to the hospital 3 months after you start the trial medication for a blood test and to make sure that you are not having any undesired side effects from taking the medication.
6 monthly follow up visits
We would like to see how you are once every six months, either in clinic or over the telephone. During these visits your consultant or research nurse will check how your health is. Some blood tests will be taken and you will be asked to complete some questionnaires to further assess your health and wellbeing. The follow up visits should last around 30 minutes. Your Consultant/ Research nurse will arrange further follow up appointments.
You will be enrolled on the TRACE RA study for a maximum of 6 years from the date that you join. You should continue to take the study medication each day for the full 6 years unless otherwise directed by a health professional.
You are of course free to decide not to take the trial medication at any time during the trial, if you do decide to stop taking the medication we would still want to speak to you every 6 months as originally planned to continue to monitor your health with your permission.
What am i expected to do?
You will need to take the study drug each day as directed by your consultant/ research nurse. The tablets are usually taken in the evening with a glass of water.
You will need to attend the hospital once every 6 months for your follow up visits, where possible these will be tied in with your routine RA clinic appointments to save you making additional journeys to hospital.
You should avoid drinking more than 240ml of grapefruit juice per day whilst taking part in TRACE RA. This is because grapefruit juice increases the levels of the trial drug "Atorvastatin" in the blood. In addition drinking regular, large amounts of alcohol should be avoided (4 units per day for men, and 3 units per day for women).