Detection of Annexin A2 in Systemic Lupus Erythematosus

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus (SLE); Lupus Nephritis
• Interventions: Other: ANXA2

• Registration Number: NCT03031925
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Study Start: 2017-05-09
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control subjects	ANXA2	age- and sex-matched control subjects
SLE patients	ANXA2	Systemic Lupus Erythematosus

Primary Outcome Measures

Name	Time	Method
urinary concentration of ANXA2	Day 0
serum concentration of ANXA2	Day 0

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France