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Detection of Annexin A2 in Systemic Lupus Erythematosus (ANLUP)

Primary Purpose

Systemic Lupus Erythematosus (SLE), Lupus Nephritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ANXA2
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Systemic Lupus Erythematosus (SLE) focused on measuring Annexin A2, biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for patients :

  • Age ≥ 18 years old
  • All SLE patients fulfilling the 1997 ACR criteria, followed at the Departments of Internal Medicine and Nephrology at CHU Amiens-Picardie, regardless of clinical status, treatment, and disease activity.
  • Written informed consent

Inclusion criteria for control subjects :

  • Age ≥ 18 years old
  • Written informed consent

The patients will be compared with age- and sex-matched control subjects.

Exclusion Criteria:

  • drug-induced lupus erythematosus
  • refusal or incapacity to provide a written informed consent

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SLE patients

control subjects

Arm Description

Systemic Lupus Erythematosus

age- and sex-matched control subjects

Outcomes

Primary Outcome Measures

serum concentration of ANXA2
urinary concentration of ANXA2

Secondary Outcome Measures

Full Information

First Posted
January 20, 2017
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03031925
Brief Title
Detection of Annexin A2 in Systemic Lupus Erythematosus
Acronym
ANLUP
Official Title
Detection of Annexin A2 in Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
There is substantial clinical and biological intra and inter-patient variability in SLE. Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening, leading to increased morbidity and mortality. Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE patients. Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR expression in SLE is significantly higher and significantly correlated with disease activity. Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or heterotetramer and is implicated in several biological processes. Most notably, it binds to ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated with SLE. ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated with a significant increase in vascular expression of ANXA2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE), Lupus Nephritis
Keywords
Annexin A2, biomarker

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLE patients
Arm Type
Experimental
Arm Description
Systemic Lupus Erythematosus
Arm Title
control subjects
Arm Type
Active Comparator
Arm Description
age- and sex-matched control subjects
Intervention Type
Other
Intervention Name(s)
ANXA2
Intervention Description
serum and urinary concentration
Primary Outcome Measure Information:
Title
serum concentration of ANXA2
Time Frame
Day 0
Title
urinary concentration of ANXA2
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for patients : Age ≥ 18 years old All SLE patients fulfilling the 1997 ACR criteria, followed at the Departments of Internal Medicine and Nephrology at CHU Amiens-Picardie, regardless of clinical status, treatment, and disease activity. Written informed consent Inclusion criteria for control subjects : Age ≥ 18 years old Written informed consent The patients will be compared with age- and sex-matched control subjects. Exclusion Criteria: drug-induced lupus erythematosus refusal or incapacity to provide a written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valéry SALLE, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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Detection of Annexin A2 in Systemic Lupus Erythematosus

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