Negative Antiphospholipid Syndrome: a Multicentric Study

ConditionsAntiphospholipid Syndrome Seronegative Antiphospholipid Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorItalian Society for Rheumatology

About this trial

Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.

The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Group 1 [APS]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)

Group 2 [SN-APS]: patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)

Group 3: patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases).

Age < 65 years (at event time)

Disqualifiers

Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations

Deceased patients

Less than 5 years from the first event

Trial population

Investigators plan to include a minimum sample size of 35 patients for each group; all patients will have the following features: * patients affected by Antiphospholipid syndrome (APS) or Seronegative antiphospholipid syndrome (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS * Age \<65 years (at the event time) * Less than 5 years from the first event to the beginning of the study

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Diagnostic accuracy
Other intervention
To assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/ recurrent adverse pregnancy outcomes

Treatment groups

105 Participants

are divided into 3 treatment groups

Group A: Group 1 [APS]1 intervention

Group B: Group 2 [SN-APS]1 intervention

Group C: Group 3 [Control Group]0 interventions

Trial outcomes

Primary outcomes

Diagnostic accuracy of non-criteria aPL

Evaluation of the sensitivity and specificity of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes

Time frame

0 months

Secondary outcomes

Frequency of clinical characteristics in the aPL groups

Assessment of the frequency of clinical characteristics in the four different aPL status groups, including APS and SN-APS with and without non-criteria aPL

Time frame

0 months

Incidence of recurrent thrombosis and pregnancy complications

Aestimation of the association between different aPL status on the recurrence of thrombosis/adverse pregnancy outcomes.

Time frame

0 months

Other outcomes

Prevalence of APS- and SN-APS-related antibodies in study groups

Prevalence of aCL by TLC-immunostaining, anti-carbamylated-β2-glycoprotein I antibodies and Anti-glucose-modified β2 glycoprotein I antibodies in APS and SN-APS groups

Time frame

0 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Society for Rheumatology

Lead sponsor

Source ClinicalTrials.gov

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