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Study of Neonatal IgG Fc Receptor Expression in Natural Killer T Cells Expressing an Invariant T Receptor : Implication in the Pathophysiology of Systemic Lupus

Study of Neonatal Immunoglobulin G (IgG) Fc Receptor (FcRn) Expression in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT): Implication in the Pathophysiology of Systemic Lupus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05859191
Acronym
FiNKLUPUS
Enrollment
50
Registered
2023-05-15
Start date
2023-07-21
Completion date
2030-07-01
Last updated
2026-04-30

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

Conditions

Physiopathology, Systemic Lupus Erythematosus

Keywords

lupus

Brief summary

This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.

Detailed description

The role of FcRn in autoimmune diseases remains to be clarified, but it has been implicated in numerous pathophysiological mechanisms, notably in the management of immune complexes or the recycling of autoantibodies. In humans, this role in the metabolism of autoantibodies has recently led to the development of therapeutic antibodies for autoimmune diseases such as autoimmune thrombocytopenia and myasthenia. 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, one of them being iNKT cells. Studies in patients or in lupus mouse models have shown a decrease in iNKT cells correlated with disease activity as well as tissue infiltration in relation to clinical manifestations. Their actual role in this pathology remains to be clarified between regulatory or pro-inflammatory effect. The possible role of iNKT as a regulatory cell in lupus pathology and the possible involvement of FcRn in their development reinforces the interest of their simultaneous study in humans. The aim of this study will be to evaluate the impact of the expression of FcRn and other Fc gamma receptors cooperating with FcRn (Fc gamma RII and RIII) in iNKT cells in lupus patients in relation to disease activity and therapy. This study will be conducted in parallel on monocytes, cells involved in the metabolism of immune complexes and likely to be activated by iNKT cells. These results will be compared to healthy controls and integrated into mechanistic studies in a mouse model.

Interventions

BIOLOGICALBlood sample

Three extra tubes of blood will be taken at each consultation or inpatient visit when routine blood samples are taken as part of lupus monitoring.

Sponsors

University Hospital, Tours
Lead SponsorOTHER
Research Center for Respiratory Diseases, Inserm U1100
CollaboratorUNKNOWN

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Age ≥ 18 years * Diagnosis of definite systemic lupus which may be associated with secondary antiphospholipid syndrome and/or secondary Gougerot-Sjögren's * Lupus patient, newly diagnosed or known, untreated or in relapse * Lupus patient considered stable by the treating practitioner * Requiring blood sampling for follow-up

Exclusion criteria

* Main autoimmune disease other than lupus * Patient under legal protection, guardianship or curators * Opposition to data processing

Design outcomes

Primary

MeasureTime frameDescription
FcRn Expression analysis in Circulating iNKT lymphocytesthrough study completion, an average of 3 yearby flow cytometry (mean fluorescence intensity)
FcRn Expression analysis in circulating monocytesthrough study completion, an average of 3 yearby flow cytometry (mean fluorescence intensity)
FcgammaRII Expression analysis in Circulating iNKT lymphocytesthrough study completion, an average of 3 yearby flow cytometry (mean fluorescence intensity)
FcgammaRII Expression analysis in circulating monocytesthrough study completion, an average of 3 yearby flow cytometry (mean fluorescence intensity)
FcgammaRIII Expression analysis in Circulating iNKT lymphocytesthrough study completion, an average of 3 yearby flow cytometry (mean fluorescence intensity)
FcgammaRIII Expression analysis in in circulating monocytesthrough study completion, an average of 3 yearby flow cytometry (mean fluorescence intensity)

Secondary

MeasureTime frameDescription
corticotherapythrough study completion, an average of 3 yeardata collected from patient medical file
hydroxychloroquinethrough study completion, an average of 3 yeardata collected from patient medical file
immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetilthrough study completion, an average of 3 yeardata collected from patient medical file
biotherapy: belimumab and rituximabthrough study completion, an average of 3 yeardata collected from patient medical file
lupus disease activitythrough study completion, an average of 3 yearassessed with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). The score ranging from 0 (no activity) to 105
albumin and IgG levelsthrough study completion, an average of 3 yearby immunonephelometry

Countries

France

Contacts

CONTACTYanis RAMDANI
yanis.ramdani@univ-tours.fr0234378919
CONTACTValérie GOUILLEUX-GRUART
valerie.gouilleux@univ-tours.fr
PRINCIPAL_INVESTIGATORYanis RAMDANI

CHRU de Tours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026