Anti-ficolin-2 Autoantibodies in Lupus Nephritis

Completed

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Other: BIological analysis

• Registration Number: NCT03063281
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE.

This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0).

In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels.

The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p\<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies.

Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker.

These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.

Detailed Description

For this retrospective study, the well written brief summary should be sufficient.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2015-05
• Status Verified: 2017-02
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• Age: ≥ 18 years old
• Patients with lupus diagnostic criteria (ACR1997)

Exclusion Criteria

• Pregnant women

• Patient with known evolutive cancer

  48 healthy patients matched in age and sex with one or several SLE patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SLE patient	BIological analysis	165 SLE patients. Subgroup : 77 with active lupus and 88 in disease remission. in the active subgroup : 36 with lupus nephritis and 41 without. Biological analysis were performed.
healthy patients	BIological analysis	48 healthy patients. Biological analysis were performed.

Primary Outcome Measures

Name	Time	Method
Anti-ficolin-2 antibodies presence in SLE patients	measured at day of inclusion = T0	Anti-ficolin-2 antibodies in SLE patients, considered positive if superior than 95 arbitrary units.; This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.

Secondary Outcome Measures

Name	Time	Method
Correlation of anti-ficolin-2 antibodies with anti-DNA antibodies in SLE patients	measured at day of inclusion = T0	Correlation between Anti-ficolin-2 antibodies presence and anti-DNA antibodies presence.; This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Correlation of anti-ficolin-2 antibodies with anti-C1q antibodies in SLE patients	measured at day of inclusion = T0	Correlation between Anti-ficolin-2 antibodies presence and anti-C1q antibodies presence.; This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Correlation of anti-ficolin-2 antibodies with lupus activity (SLEDAI score) in SLE	measured at day of inclusion = T0	Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of SLE activity according to SLEDAI score (2012).; This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Correlation of anti-ficolin-2 antibodies presence with active nephritis in SLE patients	measured at day of inclusion = T0	Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of active nephritis This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.