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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02625831
Acronym
ficolupus
Enrollment
213
Registered
2015-12-09
Start date
2012-11-30
Completion date
2014-05-31
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Systemic

Keywords

ficolin-3, anti-ficolin-3 antibodies, lupus nephritis, Lupus Erythematosus, Systemic, biomarker

Brief 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.

Interventions

Biological analysis : * ficolin-3 * anti-ficolin 3 antibodies * anti-C1q antibodies

Sponsors

University Hospital, Marseille
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

165 SLE patients 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

Design outcomes

Primary

MeasureTime frameDescription
Anti-ficolin-3 antibodies presence in SLE patientsmeasured at day of inclusion = T0.Anti-ficolin-3 antibodies in SLE patients, considered positive if superior than 70 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

MeasureTime frameDescription
Correlation of anti-ficolin-3 antibodies with anti-DNA antibodies in SLE patientsmeasured at day of inclusion = T0.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-3 antibodies with anti-C1q antibodies in SLE patientsmeasured at day of inclusion = T0.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-3 antibodies with lupus activity (SLEDAI score) in SLE patientsmeasured at day of inclusion = T0.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.
Anti-ficolin-3 antibodies presence in SLE patients with active nephritismeasured at day of inclusion = T0.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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026