Clinical Trials Directory

Trials / Completed

CompletedNCT03063281

Anti-ficolin-2 Autoantibodies in Lupus Nephritis

Association Between the Presence of Autoantibodies Targeting Ficolin-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus

Status
Completed
Phase
Study type
Observational
Enrollment
213 (actual)
Sponsor
University Hospital, Grenoble · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBIological analysisBiological analysis : ficolin-2 et anti-ficolin-2 antibodies

Timeline

Start date
2012-11-01
Primary completion
2013-05-01
Completion
2015-05-01
First posted
2017-02-24
Last updated
2017-02-24

Source: ClinicalTrials.gov record NCT03063281. Inclusion in this directory is not an endorsement.