Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Antiphospholipid Syndrome Thrombophilia Due to Antiphospholipid Antibody Systemic Lupus Erythematosus |
Other: Phlebotomy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus |
- Change in Annexin A5 resistance assay [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Change in D-dimer [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in activated protein C (APC) resistance coagulation assay [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in LA functional coagulation assay [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in anticardiolipin (aCL) ELISA [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in anti-B2-glycoprotein-I (aB2GPI) ELISA [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in anti-Domain-I B2GPI ELISA [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum, plasma
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
aPL positive - group 1
aPL positive with APS, receiving HCQ
|
Other: Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.
|
|
aPL positive - group 2
aPL positive with APS and SLE, receiving HCQ
|
Other: Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.
|
|
aPL positive - group 3
aPL positive without APS but with SLE, receiving HCQ
|
Other: Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.
|
|
aPL positive - group 4
aPL positive without APS or SLE, receiving HCQ
|
Other: Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.
|
|
aPL negative - group 1
aPL negative with SLE, receiving HCQ
|
Other: Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.
|
|
aPL negative - group 2
aPL negative with SLE, not receiving HCQ
|
Other: Phlebotomy
Subjects will have blood drawn at each of the 3 study visits.
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
For aPL positive groups, subjects must have persistently positive (over at least 12 weeks) antiphospholipid antibodies in the blood.
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
Contacts and Locations| Contact: Alana B Levine, MD | 212-774-2935 | hcqstudy@hss.edu |
| United States, New York | |
| Hospital for Special Surgery | Recruiting |
| New York City, New York, United States, 10021 | |
| Contact: Alana B Levine, MD 212-774-2935 hcqstudy@hss.edu | |
| Principal Investigator: | Doruk Erkan, MD | Hospital for Special Surgery, New York |
More Information
No publications provided
| Responsible Party: | Doruk Erkan, Associate Professor of Medicine, Hospital for Special Surgery, New York |
| ClinicalTrials.gov Identifier: | NCT01475149 History of Changes |
| Other Study ID Numbers: | IRB 10130 |
| Study First Received: | November 14, 2011 |
| Last Updated: | February 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hospital for Special Surgery, New York:
|
Antiphospholipid syndrome Antiphospholipid antibodies Systemic lupus erythematosus Annexin A5 and Annexin A5 resistance assay |
Additional relevant MeSH terms:
|
Antiphospholipid Syndrome Lupus Erythematosus, Systemic Thrombophilia Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Hematologic Diseases |
Annexin A5 Antibodies, Antiphospholipid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013