Research

Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients with and without Systemic Lupus Erythematosus

IRB Number: 10130
(trial not enrolling new patients)

Institutional Review Board, Hospital for Special Surgery

August 12, 2011

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.

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For further information, see Understanding Clinical Trials.

Principal Investigator

Doruk Erkan, MD

Co-Investigators

Alana B. Levine, MD
Michael D. Lockshin, MD
Jacob H. Rand, MD
JoAnn Vega

Summary

The purpose of this study is to determine the effects of a medication, hydroxychloroquine (HCQ), on a blood test called the annexin A5 (AnxA5) resistance assay in people with antiphospholipid antibodies (aPL).  People with aPL can be at increased risk for forming blood clots.  AnxA5 is a protein in the blood that protects against blood clotting.  AnxA5 does not seem to provide as much protection against blood clots in people with aPL compared to people without aPL. Studies have suggested that HCQ prevents aPL from interfering with AnxA5ís anti-clotting properties.  We will perform the AnxA5 resistance assay blood test on samples from people before and after they take HCQ.  If we can identify a difference in the test before and after people take the medication, this will allow us to design future studies.

The study will enroll fifty patients.  Subjects will be enrolled from the time of IRB approval until June 1, 2012.  Subjects will be required to participate over a period of 12 weeks.

Inclusion/Exclusion Criteria

Inclusion criteria:

  • Age 18 to 65
  • One or more of the following diagnoses: 
    • Systemic Lupus Erythematosus (SLE)
    • Antiphospholipid Syndrome (APS)
    • Positive antiphospholipid antibodies (aPL)
  • Plan to initiate treatment with hydroxychloroquine (HCQ)/Plaquenil (200-400mg/daily) (for all but five of the control subjects)

Exclusion criteria:

  • Current HCQ/Plaquenil use
  • Steroid use greater than or equal to the equivalent of prednisone 0.5 mg/kg/day at the time of enrollment
  • Heparin use at time of enrollment
  • Use of certain immunosuppressive medications
  • Acute thrombosis/blood clot within 2 weeks prior to screening
  • Pregnant women, employees, minors, mentally disabled, prisoners

Contact Information

Alana B. Levine, MD
levinea@hss.edu
212.774.2935



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