Systemic Lupus Erythematosus (SLE)NCT05934149
Lupus Landmark Study: A Prospective Registry and Biorepository
An observational study of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis, run by Lupus Research Alliance at 25 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Neuropsychiatric Systemic Lupus Erythematosus
- How many people
- 3,500 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 28 Jun 2023to Dec 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with SLE
Who may be able to join
- 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.
Who cannot join
- Not able to obtain consent
- Not able to meet protocol visit requirements
- Pregnant at the time of enrollment
Trial locations and contacts
25 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 2 countries
United States19 sites, 19 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Kennedy Vela, kennedy.vela@emory.edu
John Varghese, john.varghese@emory.edu
- Recruiting
Wallace Rheumatic Studies Center
Beverly Hills, California, 90210
Karla Alvarez, karla@danielwallacemd.com
Daniel Wallace, MD, FACP, MACR
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Christina Ndolo, cmndolo@uabmc.edu
Jose Rubio Mosquera, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Norioscar Cabello, 6177325500, ncabello@bwh.harvard.edu
Elena Massarotti, MD
- Recruiting
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Anthony Trujillo, trujilla@email.unc.edu
Shruti Saxena Beem, shruti_saxena@med.unc.edu
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Rennan Ruivivar, Rennan.Ruivivar@bsd.uchicago.edu
Yusra Irshad, yusra.irshad@bsd.uchicago.edu
- Recruiting
The MetroHealth System
Cleveland, Ohio, 44109
Antoniy Fulmes, AFulmes@metrohealth.org
Joe Finn, JFinn@metrohealth.org
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Nazeem Mohammed, Nazeem.Mohammed@UTSouthwestern.edu
Serey Ol, Serey.Ol@UTSouthwestern.edu
- Not yet recruiting
UCLA
Los Angeles, California, 90024
Brian Skaggs, 3108254321, BSkaggs@mednet.ucla.edu
Maureen McMahon, MD
- Recruiting
The Feinstein Institutes for Medical Research
Manhasset, New York, 11030
Andrew Shaw, anshaw@northwell.edu
Meggan Mackay, MD, MS
- Recruiting
University of Miami
Miami, Florida, 33146
Luis Enrique Arias Mejia, lxa2090@med.miami.edu
Niurka Colina, nxc610@miami.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Pamela Schlairet, pamela.schlairet@vumc.org
Narender Annapureddy, MD
- Not yet recruiting
Columbia University Medical Center
New York, New York, 10032
Stephen Suh, sks2231@cumc.columbia.edu
Maria Ycaza, mgy2107@cumc.columbia.edu
- Recruiting
Northwell Health
New York, New York, 11021
Radha Puran, RPuran@northwell.edu
Abdul Rehman, arehman11@northwell.edu
- Recruiting
Washington University
St Louis, Missouri, 63130
Maribel Chebuske, chebuske.m@wustl.edu
Alfred Kim, MD, PhD
- Recruiting
SUNY Upstate
Syracuse, New York, 13210
Kristina Keburia, (315) 464-6481, KeburiaK@upstate.edu
Carly Becker, beckecar@upstate.edu
- Recruiting
University of Arizona
Tucson, Arizona, 85714
Lydia Benitez, lmbenitez@arizona.edu
Kent Kwoh, MD
- Not yet recruiting
Georgetown University
Washington D.C., District of Columbia, 20057
Akua Ofori, 2026870100, ao937@georgetown.edu
Megan Lockwood, MD
- Recruiting
University of Massachusetts Memorial Health
Worcester, Massachusetts, 01605
Chelsea Boateng, chelsea.boateng@umassmed.edu
Roberto Caricchio, MD
Canada6 sites, 6 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Michaela Speirs, michaela.speirs@ucalgary.ca
Ann Clarke, MD, MSc, FRCPC
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, AB T6G 2X8
Desiree Redmond, +1 780-407-8822, dredmond@ualberta.ca
Stephanie Keeling, MD
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3H 2R9
Michele Tobaly, michele.tobaly@muhc.mcgill.ca
Sasha Bernatsky, MD
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1R 2J6
Nathalie Amiable, Nathalie.Amiable@crchudequebec.ulaval.ca
Paul Fortin, MD, MPH, FRCPC
- Recruiting
University Health Network/Toronto Western Hospital
Toronto, Ontario, M5G 2C4
Sydney Weisz, SydneyN.Weisz@uhn.ca
Zahi Touma, MD, PhD, FACP, FACR
- Recruiting
University of Manitoba
Winnipeg, Manitoba
Foluke Oyekale, 204-787-1969, Foluke.Oyekale@umanitoba.ca
Rhonda Silva, RSilva@hsc.mb.ca
About this study
Official title: Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
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).
Read the 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.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Neuropsychiatric Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Lupus Vasculitis, Central Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.
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.
Measured: up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start28 Jun 2023
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Lupus Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Lim, MD, MPH, Principal investigator, Emory UniversityArezou Khosroshahi, MD, Principal investigator, Emory UniversityAlfred Kim, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934149
- Sponsor's protocol ID
- LNX-Landmark-001
- Status last verified
- Apr 2026
- First submitted
- 23 Jun 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and specimens may be provided to other researchers for additional research use.
Publications
Staeva TP, Khosroshahi A, Kim AH, Kelly DD, Fekete MJ, Anyadike K, Baloski A, Barriteau SK, Davis A, Mitchell AM, Nepochatov N, Roesler G, Rawley-Payne M, Apruzzese W, Charbonneau A, Dowd C, Fortin PR, Hoover P, Karp DR, Koumpouras F, Lewis M, Mackay M, Mina-Osorio P, Peschken C, Shaw J, Tipple D, Touma Z, Wang A, Wilson R, Bell S, Lee A, Hurlbert MS, Stimola-Sposaro J, Pascual V, Sanz I, Schafer P, Lim SS; Lupus Landmark Study Investigators. Lupus Nexus: developing a prospective registry, biorepository and data exchange platform to foster global collaborations, accelerate research innovation and advance precision medicine in lupus. Lupus Sci Med. 2026 Jul 28;13(2):e001977. doi: 10.1136/lupus-2026-001977.
PubMed 42521601
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
- ClinicalTrials.gov ID
- NCT05934149
- Acronym / sponsor ID
- LNX-Landmark-001
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Neuropsychiatric Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Lupus Research AllianceUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SLE
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Not able to obtain consent
- Not able to meet protocol visit requirements
- Pregnant at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42521601Staeva TP, Khosroshahi A, Kim AH, Kelly DD, Fekete MJ, Anyadike K, Baloski A, Barriteau SK, Davis A, Mitchell AM, Nepochatov N, Roesler G, Rawley-Payne M, Apruzzese W, Charbonneau A, Dowd C, Fortin PR, Hoover P, Karp DR, Koumpouras F, Lewis M, Mackay M, Mina-Osorio P, Peschken C, Shaw J, Tipple D, Touma Z, Wang A, Wilson R, Bell S, Lee A, Hurlbert MS, Stimola-Sposaro J, Pascual V, Sanz I, Schafer P, Lim SS; Lupus Landmark Study Investigators. Lupus Nexus: developing a prospective registry, biorepository and data exchange platform to foster global collaborations, accelerate research innovation and advance precision medicine in lupus. Lupus Sci Med. 2026 Jul 28;13(2):e001977. doi: 10.1136/lupus-2026-001977.
- Individual participant dataSharing planned: Yes. De-identified data and specimens may be provided to other researchers for additional research use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Lim, MD, MPH principal investigator
Emory University
Arezou Khosroshahi, MD principal investigator
Emory University
Alfred Kim, MD, PhD principal investigator
Washington University School of Medicine
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis, run by Lupus Research Alliance at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lupus Nexus Director (646-884-6084, lupusnexus@lupusresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.