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Completed

NCT Number: NCT02625831

Anti-ficolin-3 Autoantibodies in Lupus Nephritis

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.

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Nephritis Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological analysis

Other

Biological analysis :

  • ficolin-3
  • anti-ficolin 3 antibodies
  • anti-C1q antibodies

Other names: Biological analysis on pre-existing serum collection

Primary outcomes

  1. Anti-ficolin-3 antibodies presence in SLE patients

    Time frame: measured 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 outcomes

  1. Correlation of anti-ficolin-3 antibodies with anti-DNA antibodies in SLE patients

    Time frame: measured 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.

  2. Correlation of anti-ficolin-3 antibodies with anti-C1q antibodies in SLE patients

    Time frame: measured 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.

  3. Correlation of anti-ficolin-3 antibodies with lupus activity (SLEDAI score) in SLE patients

    Time frame: measured 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.

  4. Anti-ficolin-3 antibodies presence in SLE patients with active nephritis

    Time frame: measured 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • University Hospital, Marseille

Registry information

Official study title

Association Between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients With Systemic Lupus Erythematosus

Acronym: ficolupus

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 9, 2015
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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