Status:
UNKNOWN
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
Lead Sponsor:
XDx
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Brief Summary
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 fl...
Detailed Description
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00671047
Start Date
December 1 2007
End Date
June 1 2010
Last Update
December 31 2008
Active Locations (12)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
3
Emory University
Atlanta, Georgia, United States, 30303
4
Kansas University Medical Center
Kansas City, Kansas, United States, 66160