Trial Information

Summary: Systemic Lupus Erythematosus (SLE) - Adults

People with systemic lupus erythematosus are asked to participate in a research study being conducted by The Feinstein Institute for Medical Research.

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

  • Are at least 18 years of age
  • Have been diagnosed with SLE

You may not participate in this study if you:

  • Have any serious disorder (including psychiatric) other than a diagnosis of SLE (ex. Congestive heart failure, angina, chronic obstructive pulmonary disease, asthma, and malignancies)
  • Have uncontrolled hypertension or diabetes
  • Have signs or symptoms of a viral infection or bacterial infection within 30 days of study start, or a recent history of repeated infections
  • Have a presence or history of vasculitis (comprising internal organs or extremities, or leading to peripheral neuropathy) within the last 3 years, presence or history of active CNS lupus (defined as seizure disorder, cerebral vascular accident, psychosis due to SLE, encephalitis, meningitis, or myelitis) requiring therapy within the last 3 years.
  • Have evidence of liver disease, moderate to severe anemia, neutropenia, or thrombocytopenia
  • Take oral or IV cyclophosphamide (or any other alkylating agent), cyclosporine (Neoral), tacrolimus (Prograf), sirolimus (Rapamune), IV immunoglobin, and/or plasmapherisis within 3 months
  • Are currently receiving mycophenolate mofetil (CellCept) or azathioprine (Imuran)
  • Have a positive protein purified derivative (PPD) test
  • Are HIV, hepatitis B, or hepatitis C positive
  • Have received a live vaccine within 3 months
  • Have had prior administration of another biologic that primary targets the immune system (eg. Rituxmab, Lymphostst-B, TACI-IG and CTLA4-Ig) within 1 year
  • Have donated blood or experience a loss of blood (more than 500mL) within 4 weeks of study start
  • Have a history of drug or alcohol abuse within the last one year
  • Are pregnant, breastfeeding, or intend to become pregnant during the study
  • Have participated in another research study within the last 30 days

For More Information,

Contact:

Sanita Kandasami, Study Coordinator
Biomedical Research Alliance of New York
The Feinstein Institute for Medical Research
350 Community Drive
Manhasset, NY 11030
Telephone: 516-562-3845
Email:

Profile Page: Biomedical Research Alliance of New York, Manhasset, NY

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

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Trial listings updated: June 1, 2008 at 6:32:36 AM


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