NCT01475149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

November 14, 2011

Last Update Submit

March 23, 2017

Conditions

Antiphospholipid SyndromeThrombophilia Due to Antiphospholipid AntibodySystemic Lupus Erythematosus

Keywords

Antiphospholipid syndromeAntiphospholipid antibodiesSystemic lupus erythematosusAnnexin A5 and Annexin A5 resistance assay

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in D-dimer

    Baseline and 12 weeks

  • Change in activated protein C (APC) resistance coagulation assay

    Baseline and 12 weeks

  • Change in LA functional coagulation assay

    Baseline and 12 weeks

  • Change in anticardiolipin (aCL) ELISA

    Baseline and 12 weeks

  • Change in anti-B2-glycoprotein-I (aB2GPI) ELISA

    Baseline and 12 weeks

  • +1 more secondary outcomes

Study Arms (6)

aPL positive - group 1

aPL positive with APS, receiving HCQ

Other: Phlebotomy

aPL positive - group 2

aPL positive with APS and SLE, receiving HCQ

Other: Phlebotomy

aPL positive - group 3

aPL positive without APS but with SLE, receiving HCQ

Other: Phlebotomy

aPL positive - group 4

aPL positive without APS or SLE, receiving HCQ

Other: Phlebotomy

aPL negative - group 1

aPL negative with SLE, receiving HCQ

Other: Phlebotomy

aPL negative - group 2

aPL negative with SLE, not receiving HCQ

Other: Phlebotomy

Interventions

PhlebotomyOTHER

Subjects will have blood drawn at each of the 3 study visits.

aPL negative - group 1aPL negative - group 2aPL positive - group 1aPL positive - group 2aPL positive - group 3aPL positive - group 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For aPL positive groups, subjects must have persistently positive (over at least 12 weeks) antiphospholipid antibodies in the blood.

You may qualify if:

  • age 18 to 65
  • new HCQ (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below)
  • persistently positive aPL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Antiphospholipid SyndromeLupus Erythematosus, Systemic

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Doruk Erkan, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 21, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

August 1, 2016

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)