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

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Thrombophilia Due to Antiphospholipid Antibody; Antiphospholipid Syndrome; Systemic Lupus Erythematosus

Treatments: Other: Phlebotomy

Study type: Observational

Funder types: Other

Identifiers

NCT01475149

IRB 10130

Details and patient eligibility

About

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.

Full 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).

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

33 participants in 6 patient groups

aPL positive - group 1

Description:

aPL positive with APS, receiving HCQ

Treatment:

Other: Phlebotomy

aPL positive - group 2

Description:

aPL positive with APS and SLE, receiving HCQ

Treatment:

Other: Phlebotomy

aPL positive - group 3

Description:

aPL positive without APS but with SLE, receiving HCQ

Treatment:

Other: Phlebotomy

aPL positive - group 4

Description:

aPL positive without APS or SLE, receiving HCQ

Treatment:

Other: Phlebotomy

aPL negative - group 1

Description:

aPL negative with SLE, receiving HCQ

Treatment:

Other: Phlebotomy

aPL negative - group 2

Description:

aPL negative with SLE, not receiving HCQ

Treatment:

Other: Phlebotomy