Antiphospholipid SyndromeNCT01475149
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
An observational study of Antiphospholipid Syndrome and Thrombophilia Due to Antiphospholipid Antibody, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antiphospholipid Syndrome, Thrombophilia Due to Antiphospholipid Antibody, Systemic Lupus Erythematosus
- What is being tested?
- Phlebotomy
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For aPL positive groups, subjects must have persistently positive (over at least 12 weeks) antiphospholipid antibodies in the blood.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus
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.
Read the 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).
- Conditions
- Antiphospholipid Syndrome, Thrombophilia Due to Antiphospholipid Antibody, Systemic Lupus Erythematosus
- Being tested
- Phlebotomy
- Keywords
- Antiphospholipid syndrome, Antiphospholipid antibodies, Systemic lupus erythematosus, Annexin A5 and Annexin A5 resistance assay
- Medical subject headings
- Antiphospholipid Syndrome, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyOther
Subjects will have blood drawn at each of the 3 study visits.
| Study group | Role | What they receive |
|---|---|---|
| aPL positive - group 1 | aPL positive with APS, receiving HCQ Receives: Other: Phlebotomy | |
| aPL positive - group 2 | aPL positive with APS and SLE, receiving HCQ Receives: Other: Phlebotomy | |
| aPL positive - group 3 | aPL positive without APS but with SLE, receiving HCQ Receives: Other: Phlebotomy | |
| aPL positive - group 4 | aPL positive without APS or SLE, receiving HCQ Receives: Other: Phlebotomy | |
| aPL negative - group 1 | aPL negative with SLE, receiving HCQ Receives: Other: Phlebotomy | |
| aPL negative - group 2 | aPL negative with SLE, not receiving HCQ Receives: Other: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
Change in D-dimer
Measured: Baseline and 12 weeks
Change in activated protein C (APC) resistance coagulation assay
Measured: Baseline and 12 weeks
Change in LA functional coagulation assay
Measured: Baseline and 12 weeks
Change in anticardiolipin (aCL) ELISA
Measured: Baseline and 12 weeks
Change in anti-B2-glycoprotein-I (aB2GPI) ELISA
Measured: Baseline and 12 weeks
Change in anti-Domain-I B2GPI ELISA
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Doruk Erkan, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475149
- Sponsor's protocol ID
- IRB 10130
- Status last verified
- Mar 2017
- First submitted
- 14 Nov 2011
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01475149
- Acronym / sponsor ID
- IRB 10130
- Conditions
- Antiphospholipid Syndrome, Thrombophilia Due to Antiphospholipid Antibody, Systemic Lupus Erythematosus
- Keywords
- Antiphospholipid syndrome, Antiphospholipid antibodies, Systemic lupus erythematosus, Annexin A5 and Annexin A5 resistance assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Montefiore Medical Center
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| aPL positive - group 1 | – | Other: PhlebotomyaPL positive with APS, receiving HCQ |
| aPL positive - group 2 | – | Other: PhlebotomyaPL positive with APS and SLE, receiving HCQ |
| aPL positive - group 3 | – | Other: PhlebotomyaPL positive without APS but with SLE, receiving HCQ |
| aPL positive - group 4 | – | Other: PhlebotomyaPL positive without APS or SLE, receiving HCQ |
| aPL negative - group 1 | – | Other: PhlebotomyaPL negative with SLE, receiving HCQ |
| aPL negative - group 2 | – | Other: PhlebotomyaPL negative with SLE, not receiving HCQ |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For aPL positive groups, subjects must have persistently positive (over at least 12 weeks) antiphospholipid antibodies in the blood.
Key inclusion criteria (11 listed)
- age 18 to 65
- new HCQ (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below)
- persistently positive aPL
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlebotomySubjects will have blood drawn at each of the 3 study visits. | Other | aPL negative - group 1, aPL negative - group 2, aPL positive - group 1, aPL positive - group 2, aPL positive - group 3, aPL positive - group 4 |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doruk Erkan, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and Thrombophilia Due to Antiphospholipid Antibody, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Annexin A5 resistance assay (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.