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

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ClinicalTrials.gov Identifier: NCT02782039
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease
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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2022





Primary Outcome Measures :
  1. Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE) [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering of APS with or without associated SLE
Criteria

Inclusion Criteria:

  • Patient with APS
  • Patient with SLE

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782039


Contacts
Contact: Nathalie Costedoat-Chalumeau, MD, PhD +33 1 58 41 32 41 nathalie.costedoat@gmail.com
Contact: Christelle AUGER, master +33 1 58 41 11 86 christelle.auger@cch.aphp.fr

Locations
France
Hôpital Claude Huriez Recruiting
Lille, France, 59000
Contact: Marc Lambert, MD, PhD    +33 3 20 44 42 96    marc.lambert@chru-lille.fr   
Contact: Eric Hachulla, MD, PhD    +33 3 20 44 42 96    eric.hachulla@chru-lille.fr   
Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Nathalie Costedoat-Chalumeau, MD, PhD    +33 1 58 41 32 41    nathalie.costedoat@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nathalie Costedoat-Chalumeau, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02782039     History of Changes
Other Study ID Numbers: NI15010
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Lupus Erythematosus, Systemic
Antiphospholipid Syndrome
Disease
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases