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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

ConditionsSystemic Lupus ErythematosusPhysiopathology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Main autoimmune disease other than lupus

Patient under legal protection, guardianship or curators

Opposition to data processing

Trial population

Adult patients with systemic lupus

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Biological/Vaccine

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: LUPUS PATIENTS1 intervention

Trial outcomes

Primary outcomes

1

FcRn Expression analysis in Circulating iNKT lymphocytes

by flow cytometry (mean fluorescence intensity)

Time frame
through study completion, an average of 3 year
2

FcRn Expression analysis in circulating monocytes

by flow cytometry (mean fluorescence intensity)

Time frame
through study completion, an average of 3 year
3

FcgammaRII Expression analysis in Circulating iNKT lymphocytes

by flow cytometry (mean fluorescence intensity)

Time frame
through study completion, an average of 3 year
4

FcgammaRII Expression analysis in circulating monocytes

by flow cytometry (mean fluorescence intensity)

Time frame
through study completion, an average of 3 year

Secondary outcomes

1

corticotherapy

data collected from patient medical file

Time frame
through study completion, an average of 3 year
2

hydroxychloroquine

data collected from patient medical file

Time frame
through study completion, an average of 3 year
3

immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil

data collected from patient medical file

Time frame
through study completion, an average of 3 year
4

biotherapy: belimumab and rituximab

data collected from patient medical file

Time frame
through study completion, an average of 3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

Research Center for Respiratory Diseases, Inserm U1100

Collaborator

Source ClinicalTrials.gov
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