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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
Sponsor:
Information provided by:

Study Description
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 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

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 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.

Study Design

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole blood, plasma, serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
XDx
Investigators
Study Director: James Yee, MD, Ph.D. XDx, Inc.
More Information

Responsible Party: Debbie Pieretti, XDx, Inc.
ClinicalTrials.gov Identifier: NCT00671047     History of Changes
Other Study ID Numbers: SL105
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by XDx:
Autoimmune Diseases
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases