The first part of this study will use the database of a large, ongoing NIH-sponsored lupus
study, Safety of Estrogen in Lupus Erythematosus National Assessment. We will examine the
levels of a blood protein known as C3a in a series of patient blood samples to see if C3a
levels predict lupus flares or are better than other blood tests, and therefore should be
used more widely in managing lupus. In the second part of the study we will add or increase
prednisone treatment on the basis of abnormalities in blood tests for C3a and dsDNA
antibodies. Early treatment based on increases in C3a and dsDNA antibodies, before the
patient develops physical signs of disease, may reduce lupus flares and, ultimately, the
patient's total steroid exposure.
We will follow study participants for 1 year on a monthly basis and do full physical
examinations and laboratory evaluations. If C3a and dsDNA antibody levels are increased
significantly above baseline levels while a patient is clinically stable, we will give the
patient either prednisone or an inactive pill (placebo) for 1 month. We will follow these
patients monthly to compare how often lupus flares occur in the two groups. This approach
could provide a novel method of preventing lupus flares, using C3a as a sensitive predictor
of flare.
Phase:
Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)