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

Lupus Erythematosus, Systemic Clinical Trial

— RFPL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896373
• Other study ID #: RIPH3-RNI18/RFPL
• Secondary ID: 2019-A00394-53
• Status: Completed
• Start date: April 17, 2019
• Est. completion date: October 18, 2020

Study information

• Verified date: February 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 18, 2020
• Est. primary completion date: October 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Other:
• Blood samples
Blood samples

Locations

Country	Name	City	State
France	Internal Medicine Service, University Hospital, Tours	Tours
France	Nephrology Service, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus	Measurement in flow cytometry of the fluorescence's mean of FcRn in each type of white blood cells	At baseline
Secondary	FcRn genotyping (FCGRT)	FcRn gene polymorphism analysis (FCGRT)	At baseline
Secondary	IGHG1 genotyping	IGHG1 gene polymorphism analysis	At baseline
Secondary	Expression of FcRn in CD16 monocytes	CD16 is used to differentiate subpopulation of monocytes. The investigators will evaluate the correlation between expression of CD16 and the fluorescence's mean of FcRn measured in flowcytometry.; This measure will be done for each population of participants	At baseline
Secondary	Expression of FcRn in macrophages	After a positive selection of monocytes obtained from participants, the investigators will measure the fluorescence's mean of FcRn in this cells for each population of participants	At baseline