Lupus Landmark Study: A Prospective Registry and Biorepository

NCT05934149 · tracked via the Priya Life Science Canada tracker

Sponsor

Lupus Research Alliance

Phase

Observational

Started

2023-06-28

Last updated

2026-04-15

Condition(s) studied

Systemic Lupus Erythematosus (SLE)Lupus NephritisNeuropsychiatric Systemic Lupus Erythematosus

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

110 Years

Healthy volunteers

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

Primary outcome measure(s)

Identify genetic drivers and antigenic targets, to elucidate mechanistic heterogeneity and correlate biomarkers to therapeutic responses. — 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.

Trial sites (25)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
University of Arizona	Tucson	Arizona	Recruiting
Wallace Rheumatic Studies Center	Beverly Hills	California	Recruiting
UCLA	Los Angeles	California	Not Yet Recruiting
Georgetown University	Washington D.C.	District of Columbia	Not Yet Recruiting
University of Miami	Miami	Florida	Recruiting
Emory University	Atlanta	Georgia	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
University of Massachusetts Memorial Health	Worcester	Massachusetts	Recruiting
Washington University	St Louis	Missouri	Recruiting
The Feinstein Institutes for Medical Research	Manhasset	New York	Recruiting
Columbia University Medical Center	New York	New York	Not Yet Recruiting
Northwell Health	New York	New York	Recruiting
SUNY Upstate	Syracuse	New York	Recruiting
UNC Chapel Hill	Chapel Hill	North Carolina	Recruiting
The MetroHealth System	Cleveland	Ohio	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
UT Southwestern Medical Center	Dallas	Texas	Recruiting
University of Calgary	Calgary	Alberta	Recruiting
University of Alberta Hospital	Edmonton	Alberta	Recruiting
University of Manitoba	Winnipeg	Manitoba	Recruiting
University Health Network/Toronto Western Hospital	Toronto	Ontario	Recruiting
McGill University Health Centre	Montreal	Quebec	Recruiting
CHU de Québec - Université Laval	Québec	Quebec	Recruiting

Other trials for the same condition

A Study of KITE-363 in Participants With Refractory Autoimmune Diseases Enrolling by invitation

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis Active, not recruiting

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) Active, not recruiting

A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants Recruiting

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05934149 on ClinicalTrials.gov ↗ ← All trials in Canada