Lupus 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 Lupus (SLE), including Lupus Nephritis (LN).
Conditions:
🦠 Systemic Lupus Erythematosus (SLE) 🦠 Lupus Nephritis 🦠 Neuropsychiatric Systemic Lupus Erythematosus
🗓️ Study Start (Actual) 28 June 2023
🗓️ Primary Completion (Estimated) December 2033
✅ Study Completion (Estimated) December 2033
👥 Enrollment (Estimated) 3500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Los Angeles, California, United States
📍 Atlanta, Georgia, United States
📍 Chicago, Illinois, United States
📍 Worcester, Massachusetts, United States
📍 New York, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Dallas, Texas, United States
📍 Winnipeg, Manitoba, Canada

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 110 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 June 2023
  • First Submitted that Met QC Criteria 5 July 2023
  • First Posted 6 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 July 2024
  • Last Update Posted 5 July 2024
  • Last Verified July 2024