Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus

NCT ID: NCT03896373

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-17

Study Completion Date

2020-10-18

Brief Summary

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This study evaluates the expression of the neonatal fc receptor (FcRn) in white blood cells and antigen-presenting cells (APC) in active lupus patients compared to inactive lupus patients and control to investigate if it's upregulated or not.

Detailed Description

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FcRn is an intracellular receptor which binds the Fc of immunoglobulins G (IgG) and albumin which induce an upgraded half-life of this two proteins.

It's extended role involve the regulation of immune complexes and anti-tumoral immunity, some studies showing a direct correlation between it's expression and the tumor surface and prognosis.

Recently a role in the upregulation of humoral response with a increase of the antibodies's diversity and a more efficient priming of lymphocyte B have been evocated.

The lupus erythematosus is an auto-immune disease mediated by IgG and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components.

In this study, by analogy with the founding in anti-tumoral immunity, the investigators hypothesised that in an active lupus disease the expression of FcRn is upregulated in the white blood cells and in APC.

This is followed by an extended half life of IgG autoantibodies and immune complexes inducing direct damages by their deposit in tissues and indirectly by upregulating the humoral response, leading to anormal production of a large panel of autoantibodies.

Conditions

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Lupus Erythematosus, Systemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Lupus erythematosus

Patients with inactive lupus erythematosus, active lupus erythematosus or newly diagnosed

Blood samples

Intervention Type OTHER

Blood samples

Interventions

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Blood samples

Blood samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Lupus erythematosus newly diagnosed or active
* Inactive lupus erythematosus
* Needing a blood sample for diagnosis or follow up
* Signed informed consent

Exclusion Criteria

* Other auto immune disease
* Pregnant or brest feeding
* Legal protection or protected adults
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie GOUILLEUX, PhD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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Internal Medicine Service, University Hospital, Tours

Tours, , France

Site Status

Nephrology Service, University Hospital, Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2019-A00394-53

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI18/RFPL

Identifier Type: -

Identifier Source: org_study_id

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