Recruiting

Observational StudyLupus Landmark Study: A Prospective Registry and Biorepository

Sponsor:

Lupus Research Alliance

Code:

NCT05934149

Conditions

Systemic Lupus Erythematosus (SLE)

Lupus Nephritis

Neuropsychiatric Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Systemic Lupus Erythematosus (SLE)

Lupus Nephritis

Neuropsychiatric Systemic Lupus Erythematosus

Study ID

NCT05934149

Start date

Jun 28, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3500 participants

Anticipated

Interventions and Outcome Measures

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lupus Nexus Director

646-884-6084 lupusnexus@lupusresearch.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Christina Ndolo

cmndolo@uabmc.edu

Principal Investigator:

Jose Rubio Mosquera, MD

University of Arizona

Recruiting

Tucson, Arizona, United States, 85714

Contacts

Lydia Benitez

lmbenitez@arizona.edu

Principal Investigator:

Kent Kwoh, MD

Wallace Rheumatic Studies Center

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Karla Alvarez

karla@danielwallacemd.com

Principal Investigator:

Daniel Wallace, MD, FACP, MACR

University of Miami

Recruiting

Miami, Florida, United States, 33146

Contacts

Luis Enrique Arias Mejia

lxa2090@med.miami.edu

Niurka Colina

nxc610@miami.edu

Principal Investigator:

Maria Carpintero, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kennedy Vela

kennedy.vela@emory.edu

John Varghese

john.varghese@emory.edu

Principal Investigator:

Arezou Khosroshahi, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Rennan Ruivivar

Rennan.Ruivivar@bsd.uchicago.edu

Yusra Irshad

yusra.irshad@bsd.uchicago.edu

Principal Investigator:

Kimberly Trotter, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Norioscar Cabello

6177325500 ncabello@bwh.harvard.edu

Principal Investigator:

Elena Massarotti, MD

University of Massachusetts Memorial Health

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Chelsea Boateng

chelsea.boateng@umassmed.edu

Principal Investigator:

Roberto Caricchio, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Maribel Chebuske

chebuske.m@wustl.edu

Principal Investigator:

Alfred Kim, MD, PhD

The Feinstein Institutes for Medical Research

Recruiting

Manhasset, New York, United States, 11030

Contacts

Andrew Shaw

anshaw@northwell.edu

Principal Investigator:

Meggan Mackay, MD, MS

Northwell Health

Recruiting

New York, New York, United States, 11021

Contacts

Radha Puran

RPuran@northwell.edu

Abdul Rehman

arehman11@northwell.edu

Principal Investigator:

Richard Furie, MD

SUNY Upstate

Recruiting

Syracuse, New York, United States, 13210

Contacts

Kristina Keburia

(315) 464-6481 KeburiaK@upstate.edu

Carly Becker

beckecar@upstate.edu

Principal Investigator:

Andras Perl, MD, PhD

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Anthony Trujillo

trujilla@email.unc.edu

Shruti Saxena Beem

shruti_saxena@med.unc.edu

Principal Investigator:

Saira Sheikh, MD

The MetroHealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Antoniy Fulmes

AFulmes@metrohealth.org

Joe Finn

JFinn@metrohealth.org

Principal Investigator:

Nora Singer, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Pamela Schlairet

pamela.schlairet@vumc.org

Principal Investigator:

Narender Annapureddy, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Nazeem Mohammed

Nazeem.Mohammed@UTSouthwestern.edu

Serey Ol

Serey.Ol@UTSouthwestern.edu

Principal Investigator:

David Karp, MD

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Michaela Speirs

michaela.speirs@ucalgary.ca

Principal Investigator:

Ann Clarke, MD, MSc, FRCPC

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, AB T6G 2X8

Contacts

Desiree Redmond

+1 780-407-8822 dredmond@ualberta.ca

Principal Investigator:

Stephanie Keeling, MD

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Foluke Oyekale

204-787-1969 Foluke.Oyekale@umanitoba.ca

Rhonda Silva

RSilva@hsc.mb.ca

Principal Investigator:

Christine Peschken, MD

University Health Network/Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Sydney Weisz

SydneyN.Weisz@uhn.ca

Principal Investigator:

Zahi Touma, MD, PhD, FACP, FACR

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3H 2R9

Contacts

Michele Tobaly

michele.tobaly@muhc.mcgill.ca

Principal Investigator:

Sasha Bernatsky, MD

CHU de Québec - Université Laval

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Nathalie Amiable

Nathalie.Amiable@crchudequebec.ulaval.ca

Principal Investigator:

Paul Fortin, MD, MPH, FRCPC

More Information

Sponsor

Lupus Research Alliance

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Lupus Research Alliance on 2026-04-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.