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Sponsored by: |
XDx |
Information provided by: | XDx |
ClinicalTrials.gov Identifier: | NCT00671047 |
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 | Intervention |
Systemic Lupus Erythematosus |
Other: non-interventional |
MedlinePlus related topics: | Lupus |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study |
Whole blood, plasma, serum
Estimated Enrollment: | 1000 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
primary care clinic
Inclusion Criteria:
Has experienced specific manifestations of lupus disease activity within the last 12 months including the following:
Exclusion Criteria:
Contact: Debbie Pieretti | 415-287-2359 | dpieretti@xdx.com |
United States, California | |||||
Cedars-Sinai Medical Center | Recruiting | ||||
Los Angeles, California, United States, 90048 | |||||
Contact: Jennifer Nelson 310-360-9197 jnelson@beverlymed.com | |||||
East Bay Rheumatology Medical Group | Recruiting | ||||
San Leandro, California, United States, 94578 | |||||
Contact: Elizabeth Von Dollen 510-357-1040 cmneuwelt@aol.com | |||||
United States, Georgia | |||||
Emory University | Recruiting | ||||
Atlanta, Georgia, United States, 30303 | |||||
Contact: Karla Caylor 404-616-7553 kcaylor@emory.edu | |||||
United States, Kansas | |||||
Kansas University Medical Center | Recruiting | ||||
Kansas City, Kansas, United States, 66160 | |||||
Contact: Sonja Price 913-588-1041 sprice@kumc.edu | |||||
United States, New York | |||||
Albert Einstein College of Medicine | Recruiting | ||||
Bronx, New York, United States, 10461 | |||||
Contact: Elena Weinstein 718-430-8766 elenajonw@hotmail.com | |||||
Hospital for Special Surgery | Recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: Roland Duculan 212-774-2967 duculanr@hss.edu | |||||
North Shore Long Island Jewish Health System | Recruiting | ||||
Lake Success, New York, United States, 11042 | |||||
Contact: Rachel Saltzman 516-708-2559 rsaltzma@NSHS.edu | |||||
New York University | Recruiting | ||||
New York, New York, United States, 10003 | |||||
Contact: Zoey Smith 646-356-9400 danijela.ivelja@nyumd.org | |||||
State University of New York | Recruiting | ||||
Brooklyn, New York, United States, 11203 | |||||
Contact: Karen Orloff 718-270-1662 karen.orloff@downstate.edu | |||||
United States, Oklahoma | |||||
Oklahoma Medical Research Foundation | Recruiting | ||||
Oklahoma City, Oklahoma, United States, 73104 | |||||
Contact: Stan Kamp 405-271-7805 Stan-Kamp@omrf.org | |||||
United States, Texas | |||||
Metroplex Clinical Research Center | Recruiting | ||||
Dallas, Texas, United States, 75235 | |||||
Contact: Casey Green 214-424-0409 CGreen@mcrcdallas.com | |||||
Canada, Ontario | |||||
Toronto Western Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5T 2S8 | |||||
Contact: Anne Mackinnon 416-603-5800 amackinn@uhnres.utoronto.ca |
XDx |
Study Director: | Chuanbo Xu, DVM, Ph.D. | XDx, Inc. |
Responsible Party: | XDx, Inc. ( Chuanbo Xu ) |
Study ID Numbers: | SL105 |
First Received: | April 30, 2008 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00671047 |
Health Authority: | United States: Institutional Review Board; Canada: Research Ethics Board |
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