Negative Antiphospholipid Syndrome: a Multicentric Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

• Less than 5 years from the first even

Locations
Other Locations
Italy
Umberto I Polyclinic, Rome- Department of Rheumatology
RECRUITING
Roma
Contact Information
Primary
Fabrizio Conti, MD
fabrizio.conti@uniroma1.it
06 49974631
Backup
Simona Truglia, MD
simona.truglia@uniroma1.it
06 49974631
Time Frame
Start Date: 2024-09-21
Estimated Completion Date: 2026-09
Participants
Target number of participants: 105
Treatments
Group 1 [APS]
Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SN-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 [Control Group]
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)
Related Therapeutic Areas
Sponsors
Leads: Italian Society for Rheumatology

This content was sourced from clinicaltrials.gov