The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study (SAGE)
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ClinicalTrials.gov 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
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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").
Condition or disease | Intervention/treatment |
---|---|
Systemic Lupus Erythematosus | Other: non-interventional |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study |
Study Start Date : | December 2007 |
Estimated Primary Completion Date : | June 2010 |
Estimated Study Completion Date : | June 2010 |

Group/Cohort | Intervention/treatment |
---|---|
1
SLE subjects with flares in the last 12 months in specific organ systems.
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Other: non-interventional
SLE nature history observational |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Individual has met the diagnostic criteria for SLE (at least 4 out of the 11) American College of Rheumatology (ACR) criteria and:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671047
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
East Bay Rheumatology Medical Group | |
San Leandro, California, United States, 94578 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30303 | |
United States, Kansas | |
Kansas University Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, New York | |
Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
State University of New York | |
Brooklyn, New York, United States, 11203 | |
North Shore Long Island Jewish Health System | |
Lake Success, New York, United States, 11042 | |
New York University | |
New York, New York, United States, 10003 | |
Hospital for Special Surgery | |
New York, New York, United States, 10021 | |
United States, Oklahoma | |
Oklahoma Medical Research Foundation | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Texas | |
Metroplex Clinical Research Center | |
Dallas, Texas, United States, 75235 | |
Canada, Ontario | |
Toronto Western Hospital | |
Toronto, Ontario, Canada, M5T 2S8 |
Study Director: | James Yee, MD, Ph.D. | XDx, Inc. |
Responsible Party: | Debbie Pieretti, XDx, Inc. |
ClinicalTrials.gov Identifier: | NCT00671047 |
Other Study ID Numbers: |
SL105 |
First Posted: | May 2, 2008 Key Record Dates |
Last Update Posted: | December 31, 2008 |
Last Verified: | December 2008 |
Autoimmune Diseases Lupus |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |