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

NCT ID: NCT00671047

Last Updated: 2008-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-06-30

Brief Summary

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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").

Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Keywords

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Autoimmune Diseases Lupus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

SLE subjects with flares in the last 12 months in specific organ systems.

non-interventional

Intervention Type OTHER

SLE nature history observational

Interventions

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non-interventional

SLE nature history observational

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XDx

INDUSTRY

Sponsor Role lead

Responsible Party

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XDx, Inc.

Principal Investigators

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James Yee, MD, Ph.D.

Role: STUDY_DIRECTOR

XDx, Inc.

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

East Bay Rheumatology Medical Group

San Leandro, California, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

State University of New York

Brooklyn, New York, United States

Site Status

North Shore Long Island Jewish Health System

Lake Success, New York, United States

Site Status

New York University

New York, New York, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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SL105

Identifier Type: -

Identifier Source: org_study_id