CompletedNot Applicable

Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)

United States33 participantsStarted 2010-09

Plain-language summary

This 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. It will measure if these patients have a change in a blood test called the annexin A5 resistance assay over that 12 week period.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18 to 65 * new HCQ (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below) * persistently positive aPL Selected Exclusion Criteria: * Steroid use greater than or equal to the equivalent of prednisone 0.5 mg/kg/day at the time of enrollment * Heparin use at the time of enrollment * Any immunosuppressive drug use within 3 months prior to screening * HCQ use within the past 6 months prior to screening visit * Another antimalarial agent treatment, * Pregnant women, minors, mentally disabled, prisoners * Acute thrombosis within 2 weeks prior to screening

What they're measuring

Change in Annexin A5 resistance assay

Timeframe: 12 weeks

Trial details

NCT IDNCT01475149

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Antiphospholipid Syndrome trials