Anti-ficolin-2 Autoantibodies in Lupus Nephritis (Ficolupus2)

February 21, 2017 updated by: University Hospital, Grenoble

Association Between the Presence of Autoantibodies Targeting Ficolin-2 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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this retrospective study, the well written brief summary should be sufficient.

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
healthy patients
48 healthy patients. Biological analysis were performed.
Other: BIological analysis
Biological analysis : ficolin-2 et anti-ficolin-2 antibodies
Other Names:
  • Biological analysis on preexisting
SLE patient
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-2 et anti-ficolin-2 antibodies
Other Names:
  • Biological analysis on preexisting

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

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 (Actual)

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2030950v0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Further analysis of serum collection is ongoing. IPD availability will be decided by the sponsor at completion and publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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