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

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

Study Overview

• Status: Completed
• Conditions: Anti-Phospholipids Syndrome (APS); Systemic Lupus Erythematosus (SLE)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 868

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Hopital Claude Huriez
  • PARIS
    • Paris, PARIS, France, 75014
      • Hôpital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering of APS with or without associated SLE

Description

Inclusion Criteria:

• Patient with APS
• Patient with SLE

Exclusion Criteria:

• Dependent person
• Hospitalized without consent and not protected by law
• Detainee

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Nathalie Costedoat-Chalumeau, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Morel N, Bonnet C, Mehawej H, Le Guern V, Perard L, Roumier M, Brezin A, Godeau B, Haroche J, Benhamou Y, Lambert M, Yelnik CM, Maillard N, Bodaghi B, Piette JC, Costedoat-Chalumeau N. CATASTROPHIC ANTIPHOSPHOLIPID SYNDROME AND POSTERIOR OCULAR INVOLVEMENT: Case Series of 11 Patients and Literature Review. Retina. 2021 Nov 1;41(11):2332-2341. doi: 10.1097/IAE.0000000000003185.
• Dupre A, Morel N, Yelnik C, Moguelet P, Le Guern V, Stammler R, Nguyen Y, Paule R, Dufrost V, Ackermann F, Benhamou Y, Godeau B, Lambert M, Duffau P, Mekinian A, Saadoun D, Mouthon L, Hachulla E, Maillard H, Levesque H, Morell-Dubois S, Leroux G, Piette JC, Chasset F, Costedoat-Chalumeau N. Cutaneous Involvement in Catastrophic Antiphospholipid Syndrome in a Multicenter Cohort of 65 Patients. JAMA Dermatol. 2023 Jan 1;159(1):62-67. doi: 10.1001/jamadermatol.2022.5221.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimated): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Antiphospholipid Syndrome
• Other Study ID Numbers: NI15010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No