The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study

Status unconfirmed

Conditions studied: Systemic Lupus Erythematosus

In brief

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").

Key facts

Study ID

NCT00671047

Run by

XDx

People needed

1000

Starts

2007-12-01

Expected to finish

2010-06-01

Last updated by the study team

2008-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individual has met the diagnostic criteria for SLE (at least 4 out of the 11) American College of Rheumatology (ACR) criteria and:
• Has experienced specific manifestations of lupus disease activity within the last 12 months including the following:
• Lupus nephritis (kidney disease); vasculitis and or central nervous system involvement and/or:
• Required treatment with at least 20 mg per day of prednisone (or equivalent) and/or:
• Required hospitalization directly due to SLE disease

You may not qualify if…

• Subjects unable or unlikely to cooperate with the procedures of the protocol
• Substance abuse / dependence that in the opinion of the investigator could compromise the subject's ability to complete the study
• Subject with a more dominant autoimmune disease, e.g. Rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, scleroderma
• History of malignancy within the last five years with the exception of basal cell carcinoma
• Active infection: Known HIV positive status, currently active tuberculosis , active infection receiving antibiotics
• Had tissue or organ transplantation (including bone marrow)
• On chronic hemo- or peritoneal dialysis

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• East Bay Rheumatology Medical Group — San Leandro, California, United States
• Emory University — Atlanta, Georgia, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• State University of New York — Brooklyn, New York, United States
• North Shore Long Island Jewish Health System — Lake Success, New York, United States
• New York University — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Toronto Western Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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