The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
SAGE
1 other identifier
observational
1,000
2 countries
12
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2007
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedDecember 31, 2008
December 1, 2008
2.5 years
April 30, 2008
December 29, 2008
Conditions
Keywords
Study Arms (1)
1
SLE subjects with flares in the last 12 months in specific organ systems.
Interventions
Eligibility Criteria
primary care clinic
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XDxlead
Study Sites (12)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
East Bay Rheumatology Medical Group
San Leandro, California, 94578, United States
Emory University
Atlanta, Georgia, 30303, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
State University of New York
Brooklyn, New York, 11203, United States
North Shore Long Island Jewish Health System
Lake Success, New York, 11042, United States
New York University
New York, New York, 10003, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Metroplex Clinical Research Center
Dallas, Texas, 75235, United States
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Biospecimen
Whole blood, plasma, serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Yee, MD, Ph.D.
XDx, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 2, 2008
Study Start
December 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
December 31, 2008
Record last verified: 2008-12