Detection of Annexin A2 in Systemic Lupus Erythematosus

Lupus Nephritis Clinical Trial

— ANLUP  

Official title:

Detection of Annexin A2 in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031925
• Other study ID #: PI2017_843_0001
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: November 9, 2018

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus (SLE)

Intervention

Other:
• ANXA2
serum and urinary concentration

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum concentration of ANXA2		Day 0
Primary	urinary concentration of ANXA2		Day 0