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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
Experimental: SLE patients
Systemic Lupus Erythematosus
serum and urinary concentration
Active Comparator: control subjects
age- and sex-matched control subjects
serum and urinary concentration
- serum concentration of ANXA2 [ Time Frame: Day 0 ]
- urinary concentration of ANXA2 [ Time Frame: Day 0 ]
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
|Contact: Valéry SALLE, MD||+33 3 22 66 82 firstname.lastname@example.org|
|Amiens, France, 80054|
|Contact: Valéry SALLE, MD +33 3 22 66 82 30 email@example.com|
|Principal Investigator:||Valéry SALLE, MD||CHU Amiens|