Lupus Landmark Study: A Prospective Registry and Biorepository

Lupus Research Alliance (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

Detailed Description

This is a multicenter registry and biorepository conducted in the United States (US) and Canada. The registry will enroll over 3500 individuals with SLE over the course of five years into one of following four cohorts:

  • New Onset: individuals with a new diagnosis of SLE

  • Active Lupus Nephritis: individuals with a recent diagnosis of LN

  • Extra-Renal Lupus Flare: individuals who have experienced a recent flare

  • Prevalent Cases: individuals with lupus who do not meet the criteria for one of the other cohorts

The registry data will include but is not limited to: patient demographics, medical history, clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), social history and determinants of health, and environmental exposures. Participants will also be asked to allow access to their medical records.

Biological samples, including whole blood, urine, saliva, stool and tissue will be collected throughout the study. These biospecimens will be used for a broad range of analyses, including genetics, genomics, proteomics, biomarker discovery and microbiome profiling.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3500 participants
Observational Model:
Time Perspective:
Official Title:
Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
Actual Study Start Date :
Jun 28, 2023
Anticipated Primary Completion Date :
Dec 1, 2033
Anticipated Study Completion Date :
Dec 1, 2033

Arms and Interventions

Arm Intervention/Treatment
New Onset

Individuals with a new diagnosis of SLE

LN Active

Individuals with a recent diagnosis of Lupus Nephritis

Extra-renal Flare

Individuals who have experienced a recent flare


Individuals with lupus who do not meet the criteria for one of the other cohorts

Outcome Measures

Primary Outcome Measures

  1. Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses. [up to 25 years]

    Resource intended to be used to address research questions based upon three categorical time frames (historical, cross-sectional, and longitudinal) with specified scientific topics proposed upon request to access the resources.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Wallace Rheumatic Studies Center Los Angeles California United States 90048
2 Emory University Atlanta Georgia United States 30303

Sponsors and Collaborators

  • Lupus Research Alliance


  • Principal Investigator: Sam Lim, MD, MPH, Emory University
  • Principal Investigator: Arezou Khosroshahi, MD, Emory University
  • Principal Investigator: Alfred Kim, MD, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Lupus Research Alliance Identifier:
Other Study ID Numbers:
  • LNX-Landmark-001
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2023