Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy ComplicationsNCT04963881
Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).
An observational study of Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy Complications, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
Evaluation of antiphospholipid antibodies (aPL) profile in Systemic lupus erythematosus (SLE) patients with obstetric and thrombotic complications. Blood sample of the patients were taken for Anti-beta-2-glycoprotein 1(anti-b2GPI), anticardiolipin (aCL) and will be analyzed on Alegria based on ELISA. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy Complications
- What is being tested?
- Antibody testing
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2019to 1 Jan 2021
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Patients of SLE, both genders, presenting with thrombosis or pregnancy complications were studied.
Who may be able to join
None listed.
Who cannot join
- Patients of SLE without thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Features and Pattern of Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).
Evaluation of antiphospholipid antibodies (aPL) profile in Systemic lupus erythematosus (SLE) patients with obstetric and thrombotic complications.
Blood sample of the patients were taken for Anti-beta-2-glycoprotein 1(anti-b2GPI), anticardiolipin (aCL) and will be analyzed on Alegria based on ELISA.
Read the detailed description
Antiphospholipid syndrome (APS) is characterized by presence of specific antiphospholipid antibodies (aPL) with history of thrombosis and/or pregnancy morbidity.
Anti-phospholipid antibodies (aPL) is a comprehensive antibody profile which includes lupus anticoagulant [LA], anticardiolipin antibodies [aCL], and/or anti-β2-glycoprotein-I antibodies [aβ2GPI]). A comprehensive antibody profile is needed for both diagnosis and classification of patients with APS, most significantly for the risk assessment of both pregnancy morbidity and thrombosis.
Double positivity (LA, aβ2GPI or ACL +) and triple positivity (LA, aβ2GPI+, ACL +) may have worse outcome and the patients with double and triple positivity may have recurrent thrombotic events.
Early detection of aPL antibodies may avert patients with many complication associated with SLE as well as from major thrombotic events because the detection of aPL in SLE has been proposed as a predictive and specific tool for the diagnosis of APLS in SLE.
aPL profile in SLE patients with obstetric and thrombotic complications was analyzed, to see the association of different anti phospholipid antibodies with different clinical features of APLS in SLE patients.
- Being tested
- Antibody testing
- Keywords
- APLS, Thrombosis, antiphosphoilipid antibodies
- Medical subject headings
- Pregnancy Complications, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody testingDiagnostic test
Blood samples were taken and analyzed for APS antibodies
What is being measured
The primary outcome is the main question the study is designed to answer.
aPLS antibodies of any type and number lead to cumulative obstetric and thrombotic complication in patients of SLE.
Measured: 2 years
B2 GPI is more prevalent in patients with antiphospholipid syndrome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start10 Oct 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy ComplicationsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheharbano Imran, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963881
- Sponsor's protocol ID
- FMHCMD
- Status last verified
- Jul 2021
- First submitted
- 18 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Pattern of Antiphospholipid Antibodies in Patients of Antiphospholipid Syndrome (APS) With Systemic Lupus Erythematosus (SLE).
- ClinicalTrials.gov ID
- NCT04963881
- Acronym / sponsor ID
- FMHCMD
- Keywords
- APLS, Thrombosis, antiphosphoilipid antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 15 Jul 2021 (actual)
- 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.
Evaluation of antiphospholipid antibodies (aPL) profile in Systemic lupus erythematosus (SLE) patients with obstetric and thrombotic complications.
Blood sample of the patients were taken for Anti-beta-2-glycoprotein 1(anti-b2GPI), anticardiolipin (aCL) and will be analyzed on Alegria based on ELISA.
Detailed description
Antiphospholipid syndrome (APS) is characterized by presence of specific antiphospholipid antibodies (aPL) with history of thrombosis and/or pregnancy morbidity.
Anti-phospholipid antibodies (aPL) is a comprehensive antibody profile which includes lupus anticoagulant [LA], anticardiolipin antibodies [aCL], and/or anti-β2-glycoprotein-I antibodies [aβ2GPI]). A comprehensive antibody profile is needed for both diagnosis and classification of patients with APS, most significantly for the risk assessment of both pregnancy morbidity and thrombosis.
Double positivity (LA, aβ2GPI or ACL +) and triple positivity (LA, aβ2GPI+, ACL +) may have worse outcome and the patients with double and triple positivity may have recurrent thrombotic events.
Early detection of aPL antibodies may avert patients with many complication associated with SLE as well as from major thrombotic events because the detection of aPL in SLE has been proposed as a predictive and specific tool for the diagnosis of APLS in SLE.
aPL profile in SLE patients with obstetric and thrombotic complications was analyzed, to see the association of different anti phospholipid antibodies with different clinical features of APLS in SLE patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of SLE, both genders, presenting with thrombosis or pregnancy complications were studied.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients of SLE without thrombosis
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 |
|---|---|---|
| Antibody testingBlood samples were taken and analyzed for APS antibodies | Diagnostic test | – |
Primary outcome
aPLS antibodies of any type and number lead to cumulative obstetric and thrombotic complication in patients of SLE.
Time frame: 2 years
B2 GPI is more prevalent in patients with antiphospholipid syndrome
Time frame: 2 years
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 15 Jul 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anti-phospholipid Antibobodies in Patients of SLE Presenting With Thrombosis or Pregnancy Complications, run by Fatima Memorial Hospital at 1 site in Pakistan.
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 0 inclusion and 1 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 15 Jul 2021. 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 Pakistan. 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?
aPLS antibodies of any type and number lead to cumulative obstetric and thrombotic complication in patients of SLE. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 15 Jul 2021.