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

NCT00671047 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2008-12-31

No results posted yet for this study

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").

Conditions

Interventions

OTHER

non-interventional

SLE nature history observational

Sponsors & Collaborators

  • XDx

    lead INDUSTRY

Principal Investigators

  • James Yee, MD, Ph.D. · XDx, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671047 on ClinicalTrials.gov