Anti-ficolin-3 Autoantibodies in Lupus Nephritis (ficolupus)

February 24, 2017 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SLE patients

165 SLE patients. Subgroup : 77 with active lupus and 88 in disease remission. in the active subgroup : 36 with lupus nephritis and 41 without.

Biological analysis were performed.
Other: Biological analysis

Biological analysis :

  • ficolin-3
  • anti-ficolin 3 antibodies
  • anti-C1q antibodies
Other Names:
  • Biological analysis on pre-existing serum collection
healthy patients
48 healthy patients. Biological analysis were performed.
Other: Biological analysis

Biological analysis :

  • ficolin-3
  • anti-ficolin 3 antibodies
  • anti-C1q antibodies
Other Names:
  • Biological analysis on pre-existing serum collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measured at day of inclusion = T0.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measured at day of inclusion = T0.
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.
measured at day of inclusion = T0.
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.
measured at day of inclusion = T0.
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.
measured at day of inclusion = T0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Hospital, Marseille

Investigators

  • Principal Investigator: Chantal DUMESTRE-PERARD, PhD, University Hospital Grenoble, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (ESTIMATE)

December 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1841851v0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

sub-study still in progress. Further analysis is needed before sponsor can decide his Policy of sharing individual data for this research.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lupus Erythematosus, Systemic

Clinical Trials on Biological analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe