Research

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)

IRB Number: 13219

Institutional Review Board, Hospital for Special Surgery

February 11, 2014

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

Nancy Pan, MD
Lisa R. Sammaritano, MD

Summary

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/Exclusion Criteria

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

Contact Information

Margaret Robotham, Clinical Research Coordinator
robothamm@hss.edu
212.774.2967



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