An Open Label Multicenter Study to Assess the Relationship Between Data Obtained with the LuGENE Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients with Systemic Lupus Erythematosus (SLE)

March 24, 2025

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

David R. Fernandez, MD, PhD
Romy Kallas, MD
 

Summary

Systemic lupus erythematosus (SLE) can be difficult to diagnosis given that there is no single test or sets of tests to identify it. Additionally, many SLE clinical features can be found in other rheumatic conditions. Because of the complexity of SLE, management is difficult to determine whether changes or persistence of clinical features are related to alterations in immunologic activity or intercurrent problems. LuGENE is a gene expression-based test that provides novel information about the status of the immune system in lupus patients. It can offer useful information to health care professionals that are not currently available. 

We expect that your taking part in this research will last approximately 2 weeks.  You will be asked to come into the clinic one time and then there will be a follow-up phone visit approximately 2 weeks after the in person visit. The in-person study visit will take approximately 2 hours and the phone visit approximately 10-25 minutes. 
 

Inclusion/Exclusion Criteria

Inclusion criteria

1. Male or female aged >/= 18 years old.
2. Capable of giving written consent on an IRB-approved Informed Consent Form prior
to any study-specific evaluation
3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing

Exclusion criteria 

1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past 30 days prior to Baseline
3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
4. Pregnant or lactating.
5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE test
 

Contact Information

Emily Wu, Research Coordinator
wue@hss.edu 
212.774.2967