Trial Information

Summary: Belimumab in subjects with SLE - Adults

People with Systemic Lupus Erythematosis (SLE) are asked to participate in a research study being conducted by North Shore Long Island Jewish Health System.

Patient Inclusion Criteria
You may be eligible to participate in this study if you:

• Are at least 18 years of age
• Have a diagnosis of lupus (SLE)
• Have been on lupus medication (corticosteroids, immunosuppressive drugs, or anti-malarias) for more than 30 days.

Patient Exclusion Criteria
You may not participate in this study if you:

• Have received treatment with any B cell targeted therapy (such as rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, or belimumab) at any time
• Have received any of the following within 30 days: A live vaccine; or A change in dose of a corticosteroid, other immunosuppressive/immunomodulatory agent, or anti-malarial agent
• Have severe lupus kidney disease
• Have active central nervous system lupus
• Have had a major organ transplant (for example, heart, lung, kidney, or liver) or stem cell/marrow transplant
• Have a history of cancer within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or cancer of the uterine cervix
• Are currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
• Have been hospitalized for treatment of infection within the last 60 days
• Use parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days
• Have a history of drug or alcohol abuse or dependence within 364 days
• Are HIV positive or have Hepatitis B
• Are pregnant, breastfeeding, or intend to become pregnant during the study
• Have participated in another research study within the last 60 days

If you would like to learn more about participating in this study, please send an e-mail message using the form below.