Antiphospholipid Syndrome, Systemic Lupus Erythematosus, Thrombophilia Due to Antiphospholipid Antibody
Conditions
Keywords
Antiphospholipid syndrome, Antiphospholipid antibodies, Systemic lupus erythematosus, Annexin A5 and Annexin A5 resistance assay
Brief 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.
Detailed description
Antiphospholipid Syndrome (APS) is an autoimmune disorder of blood clotting and pregnancy loss. It is associated with proteins called antiphospholipid antibodies (aPL) in the blood. Blood clotting in this disease occurs for several reasons; one reason involves the interaction of aPL with another protein found on the surface of the cells that line blood vessels (endothelial cells). This protein, called annexin A5 (AnxA5), forms a shield over the surface of these cells. The AnxA5 Resistance Assay is a blood test that can detect when there is a problem with the protective AnxA5 shield on endothelial cell surfaces. This 12 week study will observe patients with persistent aPL in the blood who are starting a medicine called hydroxychloroquine (HCQ). The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change. Our secondary goal is to measure a variety of other blood tests before and after patients have started taking HCQ; these tests include D-dimer, Activated Protein C (APC) Resistance, and aPL titers/status (LA test, aCL ELISA, aß2GPI ELISA, and anti-Domain-I ß2GPI ELISA).
Interventions
OTHERPhlebotomy
Subjects will have blood drawn at each of the 3 study visits.
Sponsors
Montefiore Medical Center
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Annexin A5 resistance assay | 12 weeks | The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change. |
Secondary
| Measure | Time frame |
|---|---|
| Change in activated protein C (APC) resistance coagulation assay | Baseline and 12 weeks |
| Change in LA functional coagulation assay | Baseline and 12 weeks |
| Change in D-dimer | Baseline and 12 weeks |
| Change in anti-B2-glycoprotein-I (aB2GPI) ELISA | Baseline and 12 weeks |
| Change in anti-Domain-I B2GPI ELISA | Baseline and 12 weeks |
| Change in anticardiolipin (aCL) ELISA | Baseline and 12 weeks |
Countries
United States
Outcome results
None listed