Registry and biorepository for lupus patients
Official title: Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
Run by Lupus Research Alliance · NCT05934149 · Data updated 2026-11-12
This study is gathering information and samples from over 3,500 people with lupus to help researchers learn more about the condition and improve treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | Lupus Research Alliance Academic / other |
| Locations | 25 sites (Birmingham, Alabama and 24 other locations) |
| Status | Recruiting |
| Started | June 28, 2023 |
| Main results expected | December 2035 |
| Study ends | December 2035 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT05934149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18 and older with a diagnosis of Systemic Lupus Erythematosus.
✕Probably not a fit
Patients who are unable to provide consent or are pregnant at the time of enrollment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter registry and biorepository aims to enroll over 3500 individuals with Systemic Lupus Erythematosus (SLE) over five years. Participants will be categorized into four cohorts based on their condition, including new onset SLE and active lupus nephritis. The study will collect extensive clinical data, patient-reported outcomes, and biological samples for future research on SLE. This initiative seeks to enhance understanding of lupus through comprehensive data collection and biospecimen analysis.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with lupus.
How similar studies have gone: Other studies utilizing similar registry and biorepository approaches have shown promise in advancing research and treatment for chronic diseases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand and comply with study procedures and voluntarily sign a written informed consent document * Age 18 years or older at the time of enrollment * Fulfill criteria for SLE based on one or more of the following classifications systems: Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 criteria; European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 criteria; 1997 revised ACR criteria; or Lupus is present per clinical assessment. Exclusion Criteria: * Not able to obtain consent * Not able to meet protocol visit requirements * Pregnant at the time of enrollment
Where it's running
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University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
University of Arizona
Tucson, Arizona, United States Recruiting -
Wallace Rheumatic Studies Center
Beverly Hills, California, United States Recruiting -
University of Miami
Miami, Florida, United States Recruiting -
Emory University
Atlanta, Georgia, United States Recruiting -
University of Chicago
Chicago, Illinois, United States Recruiting
Show 19 more locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
University of Massachusetts Memorial Health
Worcester, Massachusetts, United States Recruiting -
Washington University
St Louis, Missouri, United States Recruiting -
The Feinstein Institutes for Medical Research
Manhasset, New York, United States Recruiting -
Northwell Health
New York, New York, United States Recruiting -
SUNY Upstate
Syracuse, New York, United States Recruiting -
UNC Chapel Hill
Chapel Hill, North Carolina, United States Recruiting -
The MetroHealth System
Cleveland, Ohio, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting -
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting -
University of Calgary
Calgary, Alberta, Canada Recruiting -
University of Alberta Hospital
Edmonton, Alberta, Canada Recruiting -
University of Manitoba
Winnipeg, Manitoba, Canada Recruiting -
University Health Network/Toronto Western Hospital
Toronto, Ontario, Canada Recruiting -
McGill University Health Centre
Montreal, Quebec, Canada Recruiting -
CHU de Québec - Université Laval
Québec, Quebec, Canada Recruiting -
UCLA
Los Angeles, California, United States Not yet recruiting -
Georgetown University
Washington D.C., District of Columbia, United States Not yet recruiting -
Columbia University Medical Center
New York, New York, United States Not yet recruiting
Study contacts
- Principal investigator: Sam Lim, MD, MPH — Emory University
- Study coordinator: Lupus Nexus Director
- Email: lupusnexus@lupusresearch.org
- Phone: 646-884-6084
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis
This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.
-
Evaluating FT819 for autoimmune diseases
This study is testing a new treatment called FT819 to see if it can safely help people with moderate to severe autoimmune diseases feel better.
-
Comparing treatments for lupus nephritis without added oral steroids
This study is testing whether a treatment for lupus nephritis using obinutuzumab and mycophenolate mofetil without steroids can work just as well as a treatment that includes steroids.
-
Long-Term Extension of enpatoran for cutaneous lupus symptoms
This extension study tests whether continuing enpatoran is safe and helpful for people with skin lupus who completed previous trials, for up to about two years.
-
Targeting B cells and plasma cells in lupus with a dual-action antibody
A new injectable therapy (F182112) will be tested in adults with systemic lupus erythematosus to see if it can help by hitting both CD3 on immune cells and BCMA on B cells and plasma cells.
-
FT839 therapy for autoimmune diseases
This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.