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The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study

This study is currently recruiting participants.
Verified by XDx, April 2008

Sponsored by: XDx
Information provided by: XDx
ClinicalTrials.gov Identifier: NCT00671047
  Purpose

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   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study

Further study details as provided by XDx:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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.
Other: non-interventional
SLE nature history observational

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671047

Contacts
Contact: Debbie Pieretti     415-287-2359     dpieretti@xdx.com    

Locations
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    

Sponsors and Collaborators
XDx

Investigators
Study Director:     Chuanbo Xu, DVM, Ph.D.     XDx, Inc.    
  More Information


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

Keywords provided by XDx:
Autoimmune Diseases  
Lupus  

Study placed in the following topic categories:
Autoimmune Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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