Actively Recruiting
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
Led by Ampel BioSolutions, LLC · Updated on 2024-05-03
200
Participants Needed
11
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.
CONDITIONS
Official Title
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged at least 18 years old
- Able to provide written consent before any study evaluations
- Have a clinical diagnosis of SLE or incomplete lupus confirmed by a physician
- On a stable lupus treatment with no medication dose changes for at least 30 days before testing
You will not qualify if you...
- Have unstable or uncontrolled acute or chronic diseases unrelated to SLE that could affect study results or increase risk
- Received intravenous glucocorticoids at doses of 500 mg daily or more within the past month
- Current or recent (within 364 days) drug or alcohol abuse or dependence
- Pregnant or breastfeeding
- Participated in a clinical trial with an experimental agent within the past 6 weeks or 5 half-lives of the drug, whichever is longer
- Any condition that might interfere with the LuGENE�ae test as judged by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85032
Not Yet Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Providence St. John's Health Center - Rheumatology
Santa Monica, California, United States, 90404
Not Yet Recruiting
4
Yale School of Medicine
New Haven, Connecticut, United States, 06519
Not Yet Recruiting
5
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
6
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55096
Not Yet Recruiting
8
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Actively Recruiting
9
The Hospital for Special Surgery
New York, New York, United States, 10021
Not Yet Recruiting
10
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States, 28207
Actively Recruiting
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
Research Team
C
Claire Dykas
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here