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HSS Research Institute

PKRG1 in SLE

IRB Number: 2022-1251

Institutional Review Board, Hospital for Special Surgery

November 09, 2022

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Ruth Fernandez Ruiz, MD

Co-Investigators

Timothy B. Niewold, MD, FACR
Jane E. Salmon, MD

Summary

The purpose of this study is to understand the function of this the PKRG1 gene and its role in systemic lupus erythematosus (SLE).  Your biological samples and corresponding data provided by you and gathered from your medical record will be used for the purpose of this study.

A total of 60 subjects will participate in this study at HSS.

All patients will be required to participate in 1 baseline visit over the next 12 months.

  • This visit will occur whenever you come in for routine care (SLE patients).
  • Healthy controls will be asked to participate in a visit for research

Inclusion/Exclusion Criteria

Inclusion

  • Participants must be 18 years or Older
  • Must be willing to provide consent
  • Participants must be willing to provide a blood sample
  • Must have one of the following diagnoses:
    • Systemic Lupus Erythematosus (SLE) OR
    • Healthy control (no history of an autoimmune disease or be currently diagnosed with an autoimmune condition)
  • Be willing to disclose ancestral history

Exclusion

  • Unable to provide written informed consent
  • Currently taking the following biologic medications
    • belimumaborituximab (in the last 6 months)
    • obinutuzumab (in the last 6 months)
  • Currently taking cyclophosphamide (in the last 3 months)
  • Or currently taking steriods at ≥20mg/day prednisone-equivalent dose
  • History of severe lymphopenia (low white blood cells)

Contact Information

Jacqueline Paredes
paredesj@hss.edu
917.260.3137