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Research

Can Body Composition Help us Better Understand Outcomes in People with Lupus?

IRB Number: 2017-1061

Institutional Review Board, Hospital for Special Surgery

March 11, 2019

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

Lisa A. Mandl, MD, MPH

Co-Investigators

Jessica R. Berman, MD
John A. Carrino, MD, MPH
Jackie Finik
Kyriakos A. Kirou, MD, DSc, FACP
Sarah Lieber, MD
Stephen A. Paget, MD
Lisa R. Sammaritano, MD
Dina Sheira

Summary

Number of patients: 70
Enrollment period: Ongoing; anticipated completion 6/30/19
Duration of follow-up: 1 year

Inclusion/Exclusion Criteria

Inclusion criteria:

  • Women 18-70 years old followed at HSS
  • Meet American College of Rheumatology criteria for systemic lupus erythematosus

Exclusion criteria:

  • Pregnancy, active malignancy, on dialysis
  • Status post recent surgery or injury limiting participation in performance-based measures
  • Severe flare based on standard criteria
  • Presence of overlap autoimmune condition
  • Unable to complete surveys in English

Contact Information

Sarah Lieber, MD
liebers@hss.edu
212.774.2482