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

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").

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical Group
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
    • Brooklyn, New York, United States, 11203
      • State University of New York
    • Lake Success, New York, United States, 11042
      • North Shore Long Island Jewish Health System
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10003
      • New York University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation
  • Texas
    • Dallas, Texas, United States, 75235
      • Metroplex Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: XDx
• Investigators: Study Director: James Yee, MD, Ph.D., XDx, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: April 30, 2008
• First Submitted That Met QC Criteria: May 1, 2008
• First Posted (Estimate): May 2, 2008

Study Record Updates

• Last Update Posted (Estimate): December 31, 2008
• Last Update Submitted That Met QC Criteria: December 29, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Lupus; Autoimmune Diseases
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: SL105