The PLANS study seeks to understand better which lupus patients will respond well to rituximab and mycophenolate so that in the future, effective treatment could begin sooner. PLANS forms part of the MASTERPLANS programme of work funded by the Medical Research Council.
WHAT IS THE STUDY ABOUT?
On average we know that 40-60% of lupus patients respond well to any specific drug and an even smaller proportion achieve remission. Patients often need to try several other treatments before their lupus is controlled. The PLANS study will look for genes as well as chemicals and cells in the blood, urine and tissues that may help predict how well patients will respond to lupus treatment. If we can identify groups of patients who respond well to specific drugs, tests could be developed in the future to help doctors treat individual patients with the drug most likely to work best for them first time.
WHO CAN TAKE PART?
You may be eligible to take part if you are aged 12 – 80, you have active lupus, including in your skin or kidneys, you are being treated at a participating hospital and your doctor has decided, in consultation with you, to treat you with rituximab or mycophenolate. Normally your care team will invite you to take part, though do feel free to ask them if you are just about to start on rituximab or mycophenolate.
To find out if your hospital is currently included and for more information about the study, see www.lupusmasterplans.org/plans.
WHAT DOES THE STUDY INVOLVE?
The study will collect information for up to one year at some of your routine hospital appointments. We will ask for your consent to collect:
- Information about you, your lupus, your medical treatment, and how well you are;
- Extra blood samples from you at a number of different times, at the same time as your usual blood tests;
- Urine samples from you at different times;
- If you have a skin rash, a sample of it and a sample of skin without a rash, as well as taking photos of your rash. Optionally we would like to collect two further skin samples later in the study.
- A kidney sample (‘biopsy’): if your doctor thinks your lupus is affecting your kidneys and wants to take a kidney sample to check this, we would like to take a little bit extra.
Finally, we would like you to fill in some questionnaires about how you feel and about your visits to hospital and to your GP. We will then piece all this information together to identify patterns that could predict who does well or less well on rituximab and mycophenolate.
PLANS will enrol 240 UK participants. Parental or legal guardian consent will be required for participants aged 12-15 years.
If you are interested and would like to know more, speak to a member of your hospital care team, or contact the PLANS Research Team, tel. 0161 275 1616, email email@example.com