Clinical Trials Directory

Trials / Completed

CompletedNCT02625831

Anti-ficolin-3 Autoantibodies in Lupus Nephritis

Association Between the Presence of Autoantibodies Targeting Ficolin-3 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. Antibodies against Ficolin-3 were previously identified in the sera of some SLE patients, but their prevalence and significance have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-3 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE. 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-3, anti-dsDNA and anti-C1q antibodies levels were measured in sera by ELISA. First, a highly significant difference was found in the anti-ficolin-3 levels between SLE patients and healthy subjects. Anti-ficolin-3 antibodies were detected as positive in 58 of 165 (35%) SLE patients. The titer of anti-ficolin-3 antibodies was correlated with the SLEDAI score (p\<0.0001). The presence of anti-ficolin-3 antibodies was associated with anti-C1q and anti-dsDNA antibodies. Regarding associations with clinical manifestations, only the presence of active lupus nephritis was significantly associated with the presence of anti-ficolin-3 antibodies (p=0.0001). This association with renal involvement was higher with anti-ficolin-3 antibodies than with other auto-antibodies. Interestingly, the combination of anti-ficolin-3 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker. These results suggest that anti-ficolin-3 could be useful for the diagnosis of active nephritis in SLE patients.

Detailed description

For this retrospective study, a brief summary should be enough.

Conditions

Interventions

TypeNameDescription
OTHERBiological analysisBiological analysis : * ficolin-3 * anti-ficolin 3 antibodies * anti-C1q antibodies

Timeline

Start date
2012-11-01
Primary completion
2013-05-01
Completion
2014-05-01
First posted
2015-12-09
Last updated
2017-02-28

Source: ClinicalTrials.gov record NCT02625831. Inclusion in this directory is not an endorsement.