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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by XDx.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
XDx
ClinicalTrials.gov Identifier:
NCT00671047
First received: April 30, 2008
Last updated: December 29, 2008
Last verified: December 2008

April 30, 2008
December 29, 2008
December 2007
June 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00671047 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, plasma, serum

Non-Probability Sample

primary care clinic

Systemic Lupus Erythematosus
Other: non-interventional
SLE nature history observational
Other Name: non-interventional
1
SLE subjects with flares in the last 12 months in specific organ systems.
Intervention: Other: non-interventional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00671047
SL105
No
Debbie Pieretti, XDx, Inc.
XDx
Not Provided
Study Director: James Yee, MD, Ph.D. XDx, Inc.
XDx
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP