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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01475149
First Posted: November 21, 2011
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  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

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Change in Annexin A5 resistance assay [ Time Frame: 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 Outcome Measures:
  • Change in D-dimer [ Time Frame: Baseline and 12 weeks ]
  • Change in activated protein C (APC) resistance coagulation assay [ Time Frame: Baseline and 12 weeks ]
  • Change in LA functional coagulation assay [ Time Frame: Baseline and 12 weeks ]
  • Change in anticardiolipin (aCL) ELISA [ Time Frame: Baseline and 12 weeks ]
  • Change in anti-B2-glycoprotein-I (aB2GPI) ELISA [ Time Frame: Baseline and 12 weeks ]
  • Change in anti-Domain-I B2GPI ELISA [ Time Frame: Baseline and 12 weeks ]

Biospecimen Retention:   Samples Without DNA
serum, plasma

Enrollment: 33
Study Start Date: September 2010
Study Completion Date: August 2016
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475149


Locations
United States, New York
Hospital for Special Surgery
New York City, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Montefiore Medical Center
Investigators
Principal Investigator: Doruk Erkan, MD Hospital for Special Surgery, New York
  More Information

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01475149     History of Changes
Other Study ID Numbers: IRB 10130
First Submitted: November 14, 2011
First Posted: November 21, 2011
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Antibodies, Antiphospholipid
Annexin A5
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action