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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,
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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:
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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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