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

Institutional Review Board, Hospital for Special Surgery

April 01, 2008

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD

Co-Investigators

Jessica R. Berman, MD
Diana Goldenberg, MD

Summary

This research study is designed to determine whether lupus disease activities (flares) can be diagnosed from a simple blood sample.  From the blood taken for this study, the activity of your genes will be determined.  From the data obtained from your genes, and the genes of other subjects in the study, we will attempt to discover which genes can diagnose or predict lupus flare.  When such genes are discovered, it may be possible in the future to diagnose disease flare by a simple blood test. The genes might also be used in the future to design therapies to treat SLE (Systemic Lupus Erythematosus) diseases.

The study is sponsored by XDx (Expression Diagnostics), Inc.  Approximately 1000 subjects will take part in this study at several sites.  Your participation will last for one year, and during this time you will have monthly visits.  You may have additional visits if you have disease worsening (flares).

Inclusion/Exclusion Criteria

Inclusion:

• Women and men (>18 years of age) with diagnosis for SLE according to at least 4 of 11 ACR criteria, have at least one of the following criteria in the last 12 months, and are willing to consent to participate in the study:
• Hospitalized one or more times due to SLE
• Currently treated with Prednisone < 20mg/day
• Increase or addition of new immunosuppressive therapy for SLE, but is administered before study enrollment.
• At least 1 SLEDAI component of renal, CNS and/or vasculitis manifestation(s), or
• One or more BILAG score(s) of “A”, and/or
• A Physician Global Assessment score > 1.0 and with at least 1 renal, CNS and/or vasculitis manifestation(s)

Exclusion:

• Unable or unlikely to cooperate with the procedures of the protocol
• Subject with another autoimmune disease, e.g. rheumatoid arthritis, Sjogren’s syndrome,  multiple sclerosis, scleroderma, as the main condition
• Substance abuse / dependence that in the opinion of the investigator could compromise  the subject’s ability to complete the study
• History of malignancy within the last five years with the exception of basal cell  carcinoma
• Known HIV positive status, and / or currently active tuberculosis infection
• Active infection receiving antibiotics
• Had tissue or organ transplantation (including bone marrow)
• On renal dialysis currently or within the last 12 months

Contact Information

Roland Duculan
212.774.2967
duculanr@hss.edu