Skip to main content
OpenTrials
Completed

NCT Number: NCT03896373

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Internal Medicine Service, University Hospital, Tours, Tours, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

Blood samples

Primary outcomes

  1. Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus

    Time frame: At baseline

    Measurement in flow cytometry of the fluorescence's mean of FcRn in each type of white blood cells

Secondary outcomes

  1. FcRn genotyping (FCGRT)

    Time frame: At baseline

    FcRn gene polymorphism analysis (FCGRT)

  2. IGHG1 genotyping

    Time frame: At baseline

    IGHG1 gene polymorphism analysis

  3. Expression of FcRn in CD16 monocytes

    Time frame: At baseline

    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

  4. Expression of FcRn in macrophages

    Time frame: At baseline

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: RFPL

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.