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Detection of Annexin A2 in Systemic Lupus Erythematosus (ANLUP)

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ClinicalTrials.gov Identifier: NCT03031925
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus (SLE) Lupus Nephritis Other: ANXA2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Detection of Annexin A2 in Systemic Lupus Erythematosus
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : November 9, 2018
Estimated Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: SLE patients
Systemic Lupus Erythematosus
Other: ANXA2
serum and urinary concentration

Active Comparator: control subjects
age- and sex-matched control subjects
Other: ANXA2
serum and urinary concentration




Primary Outcome Measures :
  1. serum concentration of ANXA2 [ Time Frame: Day 0 ]
  2. urinary concentration of ANXA2 [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03031925


Contacts
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Contact: Valéry SALLE, MD +33 3 22 66 82 30 salle.valery@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Valéry SALLE, MD    +33 3 22 66 82 30    salle.valery@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Valéry SALLE, MD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03031925     History of Changes
Other Study ID Numbers: PI2017_843_0001
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Annexin A2
biomarker

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis