February 11, 2014
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Kyriakos A. Kirou, MD, DSc, FACP
Nancy Pan, MD
Lisa R. Sammaritano, MD
The purpose of this study is to evaluate the use of belimumab (also called Benlysta®) in adult SLE patients of black race compared to placebo for the treatment of lupus when used in combination with background treatment. Background treatment for SLE can include glucocorticoids (such as prednisone, prednisolone, and methylprednisolone), immunosuppressive agents (such as azathioprine, mycophenolate mofetil, and methotrexate) and anti-malarials (such as hydroxychloroquine). All patients will receive background treatment
Belimumab has been approved for the treatment of SLE in adults of all races. The use of belimumab in patients of black race is approved with caution since benefit varied in black patients in earlier clinical trials. An additional study is necessary to clarify the effect of belimumab treatment in patients of black race.
About 816 patients are expected to participate in this study, from around the world. Approximately 3 patients from the Hospital for Special Surgery will participate in the study. Patients will be randomly assigned into one of the following two groups:
Group 1 (2 out of 3 patients): Patient will receive belimumab every 28 days and background treatment
Group 2 (1 out of 3 patients): Patient will receive placebo every 28 days and background treatment
Your participation will involve approximately 17 study visits. Most visits are expected to last between 1 ½ and 3 hours. Follow up visits are expected to last 30 to 60 minutes.
Study participation is voluntary and is expected to last about 1 year that includes:
• Up to 4-week screening period (1-2 visits)
• 48-week treatment period (14 visits)
• 4-week post treatment follow-up (1 visit)
• 8-week follow-up period (2 visits)
Patients who complete the initial 52-week treatment period may choose to enter into an optional 6-month open-label extension where all patients will receive belimumab for an additional 6 months.
Inclusion criteria:
18 years or older
Clinical diagnosis of lupus (SLE)
Self-identified black race
Exclusion criteria:
Received belimumab (Benlysta®) at any time before
Severe kidney disease and/or lupus nephritis
Serious infections
Pregnancy
Please see the EMBRACE Study information page on clinicaltrials.gov for more information
Margaret Robotham, Clinical Research Coordinator
robothamm@hss.edu
212.774.2967