Systemic Lupus Erythematosus Clinical Trial
Official title:
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
The goal of this study is to enable the study sponsor to develop a new blood test method for
clinicians to accurately predict which individuals with lupus will flare, when the flare
will occur, and flare severity. Ultimately such a newly derived test would allow treating
physicians to start pre-emptive therapy early, with the goal of achieving remission quickly
and with a shorter duration of treatment; identify individuals who will have less severe
flares and will thus require less aggressive treatments; or intensify and lengthen treatment
for those individuals who will need such therapy.
The design of this study is to follow individuals with a known diagnosis of SLE for changes
in disease activity during the course of one year of observation. Clinical data and blood
and urine samples will be collected at scheduled monthly visits. The clinical data and blood
samples will be used for identifying gene expression profile(s) that are associated with
increases in SLE disease activity (lupus "flares").
This study is currently enrolling individuals who have an established diagnosis of SLE to participate. There is no cost to volunteers who participate and the study pays for the visits to the clinics for monthly collection of clinical information and blood and urine samples. Women who are or become pregnant may participate in the study with the recommendation of their health care providers and the study doctors. ;
Observational Model: Cohort, Time Perspective: Prospective
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