Lupus Landmark Study: A Prospective Registry and Biorepository

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05934149
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lupus Research Alliance
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sam Lim, MD, MPHArezou Khosroshahi, MDAlfred Kim, MD, PhD
Principal Investigator Affiliation	Emory UniversityEmory UniversityWashington University School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Neuropsychiatric Systemic Lupus Erythematosus

Additional Details

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.

Arms & Interventions

Arms

: 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

: Prevalent

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35205

Site Contact

Jose Rubio Mosquera, MD

[email protected]

646-884-6084

Wallace Rheumatic Studies Center, Los Angeles, California

Status