Register of Patients With Anti-Phospholipids Syndrome (AP... | NCT02782039

Studies
Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)

NCT02782039

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

868Actual

Phase

Not provided

Conditions

Anti-Phospholipids Syndrome (APS)
Systemic Lupus Erythematosus (SLE)

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2017Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Nov 11, 2015

First Submission Date that Met QC Criteria

May 20, 2016

First Posted Date

May 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE.

Detailed Description

Recruitment of patients with APS and SLE treated. Retrospective and prospective register.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

868Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with APS
Patient with SLE

Exclusion Criteria:

Dependent person
Hospitalized without consent and not protected by law
Detainee

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering of APS with or without associated SLE

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathalie Costedoat-Chalumeau, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Cochin		Paris	PARIS	75014	France
Hôpital Claude Huriez

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38972539	Derived	Mariette F, Le Guern V, Nguyen Y, Yelnik C, Morel N, Hachulla E, Lambert M, Guettrot-Imbert G, Mouthon L, Ebbo M, Costedoat-Chalumeau N. Cluster analysis of clinical manifestations assigns systemic lupus erythematosus-phenotype subgroups: A multicentre study on 440 patients. Joint Bone Spine. 2024 Dec;91(6):105760. doi: 10.1016/j.jbspin.2024.105760. Epub 2024 Jul 6.
36477813

ID	Term
D016736	Antiphospholipid Syndrome
D008180	Lupus Erythematosus, Systemic

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases