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Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus (RFPL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03896373
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Other: Blood samples

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
Lupus erythematosus
Patients with inactive lupus erythematosus, active lupus erythematosus or newly diagnosed
Other: Blood samples
Blood samples

Primary Outcome Measures :
  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 Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Blood samples from patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient included are hospitalised in the university hospital of Tours in France

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03896373

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Contact: Valérie GOUILLEUX, PhD 02 34 37 89 13 ext +33
Contact: Yanis RAMDANI, MD 02 47 47 87 36 ext +33

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Dermatology Service, University Hospital, Tours Not yet recruiting
Tours, France, 37044
Contact: Laurent MACHET, MD-PhD         
Principal Investigator: Laurent MACHET, MD-PhD         
Internal Medicine Service, University Hospital, Tours Not yet recruiting
Tours, France, 37044
Contact: François MAILLOT, MD-PhD         
Principal Investigator: François MAILLOT, MD-PhD         
Nephrology Service, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Christelle BARBET, MD         
Principal Investigator: Christelle BARBET         
Rheumatology Service, University Hospital, Tours Not yet recruiting
Tours, France, 37044
Contact: Philippe GOUPILLE, MD-PhD         
Principal Investigator: Philippe GOUPILLE, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
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Study Director: Valérie GOUILLEUX, PhD University Hospital, Tours

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Responsible Party: University Hospital, Tours Identifier: NCT03896373     History of Changes
Other Study ID Numbers: RIPH3-RNI18/RFPL
2019-A00394-53 ( Other Identifier: IdRCB )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases