Anti-Phospholipids Syndrome (APS)SAPL-LUPUSNCT02782039
Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
An observational study of Anti-Phospholipids Syndrome (APS) and Systemic Lupus Erythematosus (SLE), run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Phospholipids Syndrome (APS), Systemic Lupus Erythematosus (SLE)
- How many people
- 868 participants
- Where
- 2 sitesFrance
- Study dates
- 17 May 2017to 31 Mar 2022
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering of APS with or without associated SLE
Who may be able to join
- Patient with APS
- Patient with SLE
Who cannot join
- Dependent person
- Hospitalized without consent and not protected by law
- Detainee
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Claude Huriez
Lille, 59000
Hôpital Cochin
Paris, PARIS, 75014
About this study
The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE.
Read the detailed description
Recruitment of patients with APS and SLE treated. Retrospective and prospective register.
- Medical subject headings
- Antiphospholipid Syndrome, Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start17 May 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anti-Phospholipids Syndrome (APS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Nathalie Costedoat-Chalumeau, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782039
- Sponsor's protocol ID
- NI15010
- Acronym
- SAPL-LUPUS
- Status last verified
- Oct 2025
- First submitted
- 11 Nov 2015
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sorin B, Morel N, Nguyen Y, Clarke A, Stammler R, Le Guern V, Costedoat-Chalumeau N. Immune thrombocytopenia is rare in patients with antiphospholipid syndrome without systemic lupus erythematosus: insights from a series of 351 patients. Lupus Sci Med. 2026 Aug 11;13(2):e002084. doi: 10.1136/lupus-2026-002084.
PubMed 42580760Mariette 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.
PubMed 38972539Dupre 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.
PubMed 36477813Morel 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.
PubMed 33840791