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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03896373
Acronym
RFPL
Enrollment
48
Registered
2019-04-01
Start date
2019-04-17
Completion date
2020-10-18
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Systemic

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.

Interventions

OTHERBlood samples

Blood samples

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosusAt baselineMeasurement in flow cytometry of the fluorescence's mean of FcRn in each type of white blood cells

Secondary

MeasureTime frameDescription
FcRn genotyping (FCGRT)At baselineFcRn gene polymorphism analysis (FCGRT)
IGHG1 genotypingAt baselineIGHG1 gene polymorphism analysis
Expression of FcRn in CD16 monocytesAt baselineCD16 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
Expression of FcRn in macrophagesAt baselineAfter 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026