Registry and biorepository for lupus patients
Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
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 |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Lupus Research Alliance Academic / other |
| Locations | 25 sites (Birmingham, Alabama and 24 other locations) |
| Trial ID | NCT05934149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with a diagnosis of Systemic Lupus Erythematosus.
Not a fit: Patients who are unable to provide consent or are pregnant at the time of enrollment may not benefit from this study.
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 performed: Other studies utilizing similar registry and biorepository approaches have shown promise in advancing research and treatment for chronic diseases.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 24 other locations
- 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)
- UCLA — Los Angeles, California, United States (Not_yet_recruiting)
- Georgetown University — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- 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)
- Columbia University Medical Center — New York, New York, United States (Not_yet_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)
Study contacts
- Principal investigator: Sam Lim, MD, MPH — Emory University
- Study coordinator: Lupus Nexus Director
- Email: lupusnexus@lupusresearch.org
- Phone: 646-884-6084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.