IFN3958g Study
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What is the IFN3958g Study?
IFN3958g is a phase I study in adults with Mildly Active Systemic Lupus Erythematosus. The purpose of this study is to investigate the safety of rhuMAb IFNalpha for the treatment of systemic lupus erythematosus (SLE) in adults with SLE. Interferon alpha (called IFNalpha in this document) is a protein produced by many different cells in your body. One of its many roles is helping the body defend itself against viral infections. Studies have shown that IFNalpha (one of three major classes of interferon), is produced in excessive amounts in some patients with SLE, and it is believed that IFNalpha may contribute to the development of SLE.
rhuMAb IFNalpha is an antibody that has been designed to specifically bind to IFNalpha and make it inactive. rhuMAb IFNalpha is being developed as a possible treatment for SLE and other diseases in which increased amounts of interferon may be involved.
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Goals of Study
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The study drug given in this study is not intended as treatment for SLE. You may not receive any benefit from taking part in the study as we do not know whether treatment with rhuMAb IFNalpha helps patients with SLE. However, the information gained in this study could help patients with SLE in the future.
The close medical attention required by this study may result in you gaining new information about your health status. Who is Participating?
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To be eligible for this study, subjects must be between the ages of 18-65, have a diagnosis of SLE for at least 1 year, be clinically stable with only mild disease and have not received recent immunosuppressive medication.
What is Involved?
Approximately 34 study visits are required during the screening, treatment, and follow-up periods of this study over the course of about 1 year. The visits will last approximately 2 hours for the screening visit, 6-8 hours on the days you receive the study drug and 1-2 hours for all other visits.
Contact Information
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Principal Investigator: Dr. Mary Anne Dooley
Lupus Clinical Trials Coordinator: Brenda Meier, RN (919-843-6619)