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, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35205

Site Contact

Shamanta Ramesh

[email protected]

646-884-6084

Wallace Rheumatic Studies Center, Beverly Hills, California

Status

Recruiting

Address

Wallace Rheumatic Studies Center

Beverly Hills, California, 90210

Site Contact

Florence Figueras

[email protected]

646-884-6084

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33146

Site Contact

Niurka Colina

[email protected]

646-884-6084

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Site Contact

Kennedy Vela

[email protected]

646-884-6084

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Site Contact

Rennan Ruivivar

[email protected]

646-884-6084

Worcester, Massachusetts

Status

Recruiting

Address

University of Massachusetts Memorial Health

Worcester, Massachusetts, 01605

Site Contact

Mohan Pahari

[email protected]

646-884-6084

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63130

Site Contact

Maribel Chebuske

[email protected]

646-884-6084

Manhasset, New York

Status

Recruiting

Address

The Feinstein Institutes for Medical Research

Manhasset, New York, 11030

Site Contact

Andrew Shaw

[email protected]

646-884-6084

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Site Contact

Leila Khalili, MSN APRN, FNP-C

[email protected]

212-305-4308

Northwell Health, New York, New York

Status

Recruiting

Address

Northwell Health

New York, New York, 11021

Site Contact

Abdul Rehman

[email protected]

516-708-2559

SUNY Upstate, Syracuse, New York

Status

Recruiting

Address

SUNY Upstate

Syracuse, New York, 13210

Site Contact

Bryan Blaker

[email protected]

315-464-6481

UNC Chapel Hill, Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Roger Huamani Velasquez

[email protected]

646-884-6084

The MetroHealth System, Cleveland, Ohio

Status

Recruiting

Address

The MetroHealth System

Cleveland, Ohio, 44109

Site Contact

Tudor Lungu

[email protected]

646-884-6084

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Pamela Krueger

[email protected]

646-884-6084

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Azza Mutwally Badr

[email protected]

214-648-7219

International Sites

University of Calgary, Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary

Calgary, Alberta, T2N 1N4

Site Contact

Michaela Speirs

[email protected]

646-884-6084

University of Manitoba, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

University of Manitoba

Winnipeg, Manitoba,

Site Contact

Rhonda Silva

[email protected]

204-787-1969

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network/Toronto Western Hospital

Toronto, Ontario, M5G 2C4

Site Contact

Joanna Cichon

[email protected]

646-884-6084

McGill University Health Centre, Montréal, Quebec, Canada

Status

Not yet recruiting

Address

McGill University Health Centre

Montréal, Quebec, H3H 2R9

Site Contact

Michele Tobaly

[email protected]

646-884-6084

CHU de Québec - Université Laval, Quebec City, Quebec, Canada

Status

Recruiting

Address

CHU de Québec - Université Laval

Quebec City, Quebec, G1R 2J6

Site Contact

Nathalie Amiable

[email protected]

646-884-6084