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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT02782039
- Acronym / sponsor ID
- SAPL-LUPUS / NI15010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 May 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering of APS with or without associated SLE
Key inclusion criteria (2 listed)
- Patient with APS
- Patient with SLE
Key exclusion criteria (3 listed)
- Dependent person
- Hospitalized without consent and not protected by law
- Detainee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 42580760Sorin 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.
- Derived from this study: PubMed 38972539Mariette 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.
- Derived from this study: PubMed 36477813Dupre 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.
- Derived from this study: PubMed 33840791Morel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Costedoat-Chalumeau, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782039, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.