Clinical trial NCT03063281: Anti-ficolin-2 Autoantibodies in Lupus Nephritis
Official title: Association Between the Presence of Autoantibodies Targeting Ficolin-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus, Systemic
Keywords: ficolin-2
anti-ficolin-2 antibodies
lupus nephritis
Lupus Erythematosus, Systemic
biomarker
ficolin-3
anti-ficolin-3 antibodies
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Marseille
First posted: 2017-02-24
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SLE patients were studied from medical data files of the Departments of Internal Medicine (Grenoble University Hospital, France) and Nephrology (Conception University Hospital, Marseille, France). For SLE patients, clinical and biological manifestations as well as treatments received and disease activity evaluated using the SLE Disease Activity Index (SLEDAI) at the time of sampling were recorded. SLE patients were divided into subgroups as described in group section.

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.

Eligibility 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

Primary outcomes:
measure: Anti-ficolin-2 antibodies presence in SLE patients
timeFrame: measured at day of inclusion = T0
Secondary outcomes:
measure: Correlation of anti-ficolin-2 antibodies with anti-DNA antibodies in SLE patients
timeFrame: measured at day of inclusion = T0
measure: Correlation of anti-ficolin-2 antibodies with anti-C1q antibodies in SLE patients
timeFrame: measured at day of inclusion = T0
measure: Correlation of anti-ficolin-2 antibodies with lupus activity (SLEDAI score) in SLE
timeFrame: measured at day of inclusion = T0
measure: Correlation of anti-ficolin-2 antibodies presence with active nephritis in SLE patients
timeFrame: measured at day of inclusion = T0
Other outcomes:
Locations:
Study officials:
References:
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