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

Systemic Lupus Erythematosus Clinical Trial

Official title:

Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475149
• Other study ID #: IRB 10130
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: March 23, 2017
• Start date: September 2010
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Thrombophilia
• Thrombophilia Due to Antiphospholipid Antibody

Intervention

Other:
• Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Annexin A5 resistance assay	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.	12 weeks
Secondary	Change in D-dimer		Baseline and 12 weeks
Secondary	Change in activated protein C (APC) resistance coagulation assay		Baseline and 12 weeks
Secondary	Change in LA functional coagulation assay		Baseline and 12 weeks
Secondary	Change in anticardiolipin (aCL) ELISA		Baseline and 12 weeks
Secondary	Change in anti-B2-glycoprotein-I (aB2GPI) ELISA		Baseline and 12 weeks
Secondary	Change in anti-Domain-I B2GPI ELISA		Baseline and 12 weeks