You will be asked a series of questions to see if you might be eligible to join the study. If you are eligible at this point you will be asked to attend a Hospital to be asked more details about your condition and be examined and have blood and urine tests. If this assessment confirms you are eligible, you will be entered into the study and will be invited to attend the Hospital again.
You will return to hospital to have further blood tests and an ECG (a test of your heart). If you are a woman and of child bearing age then you will have a pregnancy test at each visit and as noted below you will be asked to use appropriate contraception so that you will not get pregnant whilst you are in the study. Tests will be run for serious infections such as HIV or Hepatitis. All these tests are tests you would have as part of your normal care.
This is a randomised study. We don‘t know the best way of treating patients after B cell depletion therapy. To find out, we need to compare a new treatment (belimumab) with usual treatment. We will put people into groups and give one group belimumab and the other group the usual treatment. The results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly). The decision as to which group you will be put in will be made by a computer. Half the patients receive belimumab and half receive placebo. Both treatments will be given by intravenous infusion. The placebo treatment will look the same as belimumab but contains no active drug. The reason for including a placebo is so neither you nor your doctor knows whether belimumab has been given. Sometimes simply knowing what treatment has been given can affect the way a patient is feeling. We will be able to compare the information from patients in the belimumab group, with the information from the placebo group and be able to determine what effect belimumab is having on Lupus.
Your doctor will be able to find out which group you are in should there be a need to, but this does not usually happen while you are taking part in the study. All patients will be invited to attend for an infusion of the study medication which will last an hour (but you may be monitored for a few hours after the first couple of infusions) and you will repeat treatments and assessments, usually every four weeks. The results of the study will be available for general use by researchers in the field of Lupus, to ensure that the information gathered from the study is put to maximum use. Your personal details will not be revealed at any stage.