Clinical trial NCT03896373: Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus
Official title: Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient included are hospitalised in the university hospital of Tours in France

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus
timeFrame: At baseline
Secondary outcomes:
measure: FcRn genotyping (FCGRT)
timeFrame: At baseline
measure: IGHG1 genotyping
timeFrame: At baseline
measure: Expression of FcRn in CD16 monocytes
timeFrame: At baseline
measure: Expression of FcRn in macrophages
timeFrame: At baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: Internal Medicine Service, University Hospital, Tours
city: Tours
country: France
facility: Nephrology Service, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Valérie GOUILLEUX, PhD
role: STUDY_DIRECTOR
References: