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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

Tracking Information
First Submitted Date November 11, 2015
First Posted Date May 25, 2016
Last Update Posted Date March 19, 2018
Actual Study Start Date May 17, 2017
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2016)
Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE) [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02782039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
Official Title Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients suffering of APS with or without associated SLE
Condition
  • Anti-Phospholipids Syndrome (APS)
  • Systemic Lupus Erythematosus (SLE)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2016)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient with APS
  • Patient with SLE

Exclusion Criteria:

  • Dependent person
  • Hospitalized without consent and not protected by law
  • Detainee
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02782039
Other Study ID Numbers NI15010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Nathalie Costedoat-Chalumeau, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2018