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
Verified date | March 2017 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York | Montefiore Medical Center |
United States,
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 |
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