Clinical trial NCT01475149: Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
Official title: Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiphospholipid Syndrome
Thrombophilia Due to Antiphospholipid Antibody
Systemic Lupus Erythematosus
Keywords: Antiphospholipid syndrome
Antiphospholipid antibodies
Systemic lupus erythematosus
Annexin A5 and Annexin A5 resistance assay
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
First posted: 2011-11-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For aPL positive groups, subjects must have persistently positive (over at least 12 weeks) antiphospholipid antibodies in the blood.

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).

Eligibility 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

Primary outcomes:
measure: Change in Annexin A5 resistance assay
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in D-dimer
timeFrame: Baseline and 12 weeks
measure: Change in activated protein C (APC) resistance coagulation assay
timeFrame: Baseline and 12 weeks
measure: Change in LA functional coagulation assay
timeFrame: Baseline and 12 weeks
measure: Change in anticardiolipin (aCL) ELISA
timeFrame: Baseline and 12 weeks
measure: Change in anti-B2-glycoprotein-I (aB2GPI) ELISA
timeFrame: Baseline and 12 weeks
measure: Change in anti-Domain-I B2GPI ELISA
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: New York City
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Doruk Erkan, MD
role: PRINCIPAL_INVESTIGATOR
References: