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Completed

NCT Number: NCT03063281

Anti-ficolin-2 Autoantibodies in Lupus Nephritis

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.

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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, the well written brief summary should be sufficient.

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-2 et anti-ficolin-2 antibodies

Other names: Biological analysis on preexisting

Primary outcomes

  1. Anti-ficolin-2 antibodies presence in SLE patients

    Time frame: measured at day of inclusion = T0

    Anti-ficolin-2 antibodies in SLE patients, considered positive if superior than 95 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-2 antibodies with anti-DNA antibodies in SLE patients

    Time frame: measured at day of inclusion = T0

    Correlation between Anti-ficolin-2 antibodies presence and anti-DNA antibodies presence.

    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-2 antibodies with anti-C1q antibodies in SLE patients

    Time frame: measured at day of inclusion = T0

    Correlation between Anti-ficolin-2 antibodies presence and anti-C1q antibodies presence.

    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-2 antibodies with lupus activity (SLEDAI score) in SLE

    Time frame: measured at day of inclusion = T0

    Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of SLE activity according to SLEDAI score (2012).

    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. Correlation of anti-ficolin-2 antibodies presence with active nephritis in SLE patients

    Time frame: measured at day of inclusion = T0

    Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of active nephritis 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-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus

Acronym: Ficolupus2

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Feb 24, 2017
Registry last updated
Feb 24, 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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