Detection of Annexin A2 in Systemic Lupus Erythematosus

NCT03031925 | Completed

• 1 other identifier: PI2017_843_0001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus (SLE); Lupus Nephritis

Keywords

Annexin A2; biomarker

Outcome Measures

Primary Outcomes (2)

• serum concentration of ANXA2

  Day 0

• urinary concentration of ANXA2

  Day 0

Study Arms (2)

SLE patients

EXPERIMENTAL

Systemic Lupus Erythematosus

Other: ANXA2

control subjects

ACTIVE COMPARATOR

age- and sex-matched control subjects

Other: ANXA2

Interventions

ANXA2 OTHER

serum and urinary concentration

SLE patients; control subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 18 years old
• Written informed consent
• The patients will be compared with age- and sex-matched control subjects.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Valéry SALLE, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 26, 2017
• Study Start: May 9, 2017
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

FR (1)