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 Canada, 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 4049979, Alabama 4829764

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham 4049979, Alabama 4829764, 35205

Site Contact

Christina Ndolo

[email protected]

646-884-6084

University of Arizona, Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

University of Arizona

Tucson 5318313, Arizona 5551752, 85714

Site Contact

Lydia Benitez

[email protected]

646-884-6084

Wallace Rheumatic Studies Center, Beverly Hills 5328041, California 5332921

Status

Recruiting

Address

Wallace Rheumatic Studies Center

Beverly Hills 5328041, California 5332921, 90210

Site Contact

Karla Alvarez

[email protected]

646-884-6084

University of Miami, Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami

Miami 4164138, Florida 4155751, 33146

Site Contact

Luis Enrique Arias Mejia

[email protected]

646-884-6084

Emory University, Atlanta 4180439, Georgia 4197000

Status

Recruiting

Address

Emory University

Atlanta 4180439, Georgia 4197000, 30322

Site Contact

Kennedy Vela

[email protected]

646-884-6084

University of Chicago, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

University of Chicago

Chicago 4887398, Illinois 4896861, 60637

Site Contact

Rennan Ruivivar

[email protected]

646-884-6084

Worcester 4956184, Massachusetts 6254926

Status

Recruiting

Address

University of Massachusetts Memorial Health

Worcester 4956184, Massachusetts 6254926, 01605

Site Contact

Chelsea Boateng

[email protected]

646-884-6084

Washington University, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University

St Louis 4407066, Missouri 4398678, 63130

Site Contact

Maribel Chebuske

[email protected]

646-884-6084

Manhasset 5125766, New York 5128638

Status

Not yet recruiting

Address

The Feinstein Institutes for Medical Research

Manhasset 5125766, New York 5128638, 11030

Site Contact

Andrew Shaw

[email protected]

646-884-6084

Columbia University Medical Center, New York 5128581, New York 5128638

Status

Not yet recruiting

Address

Columbia University Medical Center

New York 5128581, New York 5128638, 10032

Site Contact

Stephen Suh

[email protected]

646-884-6084

Northwell Health, New York 5128581, New York 5128638

Status

Recruiting

Address

Northwell Health

New York 5128581, New York 5128638, 11021

Site Contact

Radha Puran

[email protected]

646-884-6084

SUNY Upstate, Syracuse 5140405, New York 5128638

Status

Recruiting

Address

SUNY Upstate

Syracuse 5140405, New York 5128638, 13210

Site Contact

Bryan Blaker

[email protected]

(315) 464-6481

UNC Chapel Hill, Chapel Hill 4460162, North Carolina 4482348

Status

Recruiting

Address

UNC Chapel Hill

Chapel Hill 4460162, North Carolina 4482348, 27599

Site Contact

Roger Huamani Velasquez

[email protected]

646-884-6084

The MetroHealth System, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

The MetroHealth System

Cleveland 5150529, Ohio 5165418, 44109

Site Contact

Antoniy Fulmes

[email protected]

646-884-6084

Vanderbilt University Medical Center, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville 4644585, Tennessee 4662168, 37232

Site Contact

Pamela Krueger

[email protected]

646-884-6084

UT Southwestern Medical Center, Dallas 4684888, Texas 4736286

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas 4684888, Texas 4736286, 75390

Site Contact

Margaret Wright

[email protected]

646-884-6084

International Sites

University of Calgary, Calgary 5913490, Alberta 5883102, Canada

Status

Recruiting

Address

University of Calgary

Calgary 5913490, Alberta 5883102, T2N 1N4

Site Contact

Michaela Speirs

[email protected]

646-884-6084

University of Manitoba, Winnipeg 6183235, Manitoba 6065171, Canada

Status

Recruiting

Address

University of Manitoba

Winnipeg 6183235, Manitoba 6065171,

Site Contact

Rhonda Silva

[email protected]

204-787-1969

Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

University Health Network/Toronto Western Hospital

Toronto 6167865, Ontario 6093943, M5G 2C4

Site Contact

Sydney Weisz

[email protected]

646-884-6084

McGill University Health Centre, Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

McGill University Health Centre

Montreal 6077243, Quebec 6115047, H3H 2R9

Site Contact

Michele Tobaly

[email protected]

646-884-6084

CHU de Québec - Université Laval, Québec 6325494, Quebec 6115047, Canada

Status

Recruiting

Address

CHU de Québec - Université Laval

Québec 6325494, Quebec 6115047, G1R 2J6

Site Contact

Nathalie Amiable

[email protected]

646-884-6084