A Phase 3/4 Multi-Center Randomized Double-Blind Placebo Controlled 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race with Systemic Lupus Erythematosus (SLE)
ID Number 13-1116Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to find out if Belimumab is effective and safe in treating patients of black race who have lupus and are receiving other lupus medicines. Lupus occurs more frequently in people of black race and when it does occur it is often more severe.
In the studies that have already been completed with Belimumab not enough black patients participated to be able to understand the effect of Belimumab in black patients. This was because some of the study results showed that fewer black patients who received Belimumab responded to treatment compared with black patients who did not receive Belimumab, while other study results showed that black patients responded at least as well as patients of other races. In these studies side effects were similar in black patients who received Belimumab (about 150 patients) and those who did not (74 patients).
It is important to understand if black patients with lupus improve with Belimumab treatment which is the purpose of this study.
If subjects finish Part 2 of the study, and their doctor believes they are benefiting from treatment, but Belimumab is not available by prescription in their country at that time, subjects may continue to receive Belimumab in a continuation study until such time that Belimumab is available by prescription. Subjects will be given information about the continuation study at that time and there will be a separate consent form that subjects will be asked to sign before enrolling.
If subjects finish Part 2 of the study and Belimumab is available by prescription in their country, they will not be eligible to participate in the continuation study. However if their doctor feels they are benefiting from treatment with Belimumab, he/she may prescribe it for them. If subjects are prescribed Belimumab, the charges may be billed to subjects or their insurance company. These charges should be explained to subjects by their doctor or his/her staff.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 816. If subjects decide to take part in this research study they will be responsible for the following things: Following the instructions tests and procedures described earlier in this consent form; Attending all scheduled study visits; Use of effective birth control described earlier in this consent form; Avoiding certain medications described in the consent form.
Recruiting Patients: No