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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671047
Recruitment Status : Unknown
Verified December 2008 by XDx.
Recruitment status was:  Active, not recruiting
First Posted : May 2, 2008
Last Update Posted : December 31, 2008
Information provided by:

April 30, 2008
May 2, 2008
December 31, 2008
December 2007
June 2010   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00671047 on Archive Site
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The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
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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Retention:   Samples With DNA
Whole blood, plasma, serum
Non-Probability Sample
primary care clinic
Systemic Lupus Erythematosus
Other: non-interventional
SLE nature history observational
SLE subjects with flares in the last 12 months in specific organ systems.
Intervention: Other: non-interventional
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Debbie Pieretti, XDx, Inc.
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Study Director: James Yee, MD, Ph.D. XDx, Inc.
December 2008