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

December 29, 2008 updated by: XDx

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

This is where you will find people and organizations involved with this study.

Sponsor

XDx

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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