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Trial record 96 of 147 for:    lupus AND Lupus Nephritis

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

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ClinicalTrials.gov Identifier: NCT02625831
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
University Hospital, Marseille
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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.


Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Other: Biological analysis

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

Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Association Between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients With Systemic Lupus Erythematosus
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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 Name: 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 Name: Biological analysis on pre-existing serum collection




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
one serum sample per patient.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625831


Sponsors and Collaborators
University Hospital, Grenoble
University Hospital, Marseille
Investigators
Principal Investigator: Chantal DUMESTRE-PERARD, PhD University Hospital Grenoble, FRANCE

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02625831     History of Changes
Other Study ID Numbers: 1841851v0
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: sub-study still in progress. Further analysis is needed before sponsor can decide his Policy of sharing individual data for this research.

Keywords provided by University Hospital, Grenoble:
ficolin-3
anti-ficolin-3 antibodies
lupus nephritis
Lupus Erythematosus, Systemic
biomarker

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs