Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
Completed
Conditions studied: Antiphospholipid Syndrome, Thrombophilia Due to Antiphospholipid Antibody, Systemic Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT01475149
- Run by
- Hospital for Special Surgery, New York
- People needed
- 33
- Starts
- 2010-09-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2017-03-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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