Clinical trial NCT00671047: The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
Official title: The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Keywords: Autoimmune Diseases
Lupus
Lead sponsor: XDx
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief 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").

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Brooklyn
country: United States
facility: State University of New York
state: New York
city: Lake Success
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: XDx, Inc.
name: James Yee, MD, Ph.D.
role: STUDY_DIRECTOR
References: