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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 is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Hospital for Special Surgery, New York
Sponsor:
Collaborator:
Montefiore Medical Center
Information provided by (Responsible Party):
Doruk Erkan, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01475149
First received: November 14, 2011
Last updated: February 3, 2013
Last verified: February 2013
  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 ] [ 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.


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475149

Contacts
Contact: Alana B Levine, MD 212-774-2935 hcqstudy@hss.edu

Locations
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   
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

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:
Lupus Erythematosus, Systemic
Antiphospholipid Syndrome
Syndrome
Thrombophilia
Autoimmune Diseases
Connective Tissue Diseases
Disease
Hematologic Diseases
Immune System Diseases
Pathologic Processes
Antibodies, Antiphospholipid
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014