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

IRB Number: 2017-1061

March 11, 2019

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Co-Investigators

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