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

August 25, 2023 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients with systemic lupus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LUPUS PATIENTS
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.
Biological: Blood 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FcRn Expression analysis in Circulating iNKT lymphocytes
Time Frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
through study completion, an average of 3 year
FcRn Expression analysis in circulating monocytes
Time Frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
through study completion, an average of 3 year
FcgammaRII Expression analysis in Circulating iNKT lymphocytes
Time Frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
through study completion, an average of 3 year
FcgammaRII Expression analysis in circulating monocytes
Time Frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
through study completion, an average of 3 year
FcgammaRIII Expression analysis in Circulating iNKT lymphocytes
Time Frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
through study completion, an average of 3 year
FcgammaRIII Expression analysis in in circulating monocytes
Time Frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corticotherapy
Time Frame: through study completion, an average of 3 year
data collected from patient medical file
through study completion, an average of 3 year
hydroxychloroquine
Time Frame: through study completion, an average of 3 year
data collected from patient medical file
through study completion, an average of 3 year
immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil
Time Frame: through study completion, an average of 3 year
data collected from patient medical file
through study completion, an average of 3 year
biotherapy: belimumab and rituximab
Time Frame: through study completion, an average of 3 year
data collected from patient medical file
through study completion, an average of 3 year
albumin and IgG levels
Time Frame: through study completion, an average of 3 year
by immunonephelometry
through study completion, an average of 3 year
lupus disease activity
Time Frame: through study completion, an average of 3 year
assessed with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). The score ranging from 0 (no activity) to 105
through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Research Center for Respiratory Diseases, Inserm U1100

Investigators

  • Principal Investigator: Yanis RAMDANI, CHRU De Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR230103-FiNK LUPUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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