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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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