NCT05859191

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
51mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jul 2023Jul 2030

First Submitted

Initial submission to the registry

May 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

May 3, 2023

Last Update Submit

April 29, 2026

Conditions

PhysiopathologySystemic Lupus Erythematosus

Keywords

lupus

Outcome Measures

Primary Outcomes (6)

  • FcRn Expression analysis in Circulating iNKT lymphocytes

    by flow cytometry (mean fluorescence intensity)

    through study completion, an average of 3 year

  • FcRn Expression analysis in circulating monocytes

    by flow cytometry (mean fluorescence intensity)

    through study completion, an average of 3 year

  • FcgammaRII Expression analysis in Circulating iNKT lymphocytes

    by flow cytometry (mean fluorescence intensity)

    through study completion, an average of 3 year

  • FcgammaRII Expression analysis in circulating monocytes

    by flow cytometry (mean fluorescence intensity)

    through study completion, an average of 3 year

  • FcgammaRIII Expression analysis in Circulating iNKT lymphocytes

    by flow cytometry (mean fluorescence intensity)

    through study completion, an average of 3 year

  • FcgammaRIII Expression analysis in in circulating monocytes

    by flow cytometry (mean fluorescence intensity)

    through study completion, an average of 3 year

Secondary Outcomes (6)

  • corticotherapy

    through study completion, an average of 3 year

  • hydroxychloroquine

    through study completion, an average of 3 year

  • immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil

    through study completion, an average of 3 year

  • biotherapy: belimumab and rituximab

    through study completion, an average of 3 year

  • lupus disease activity

    through study completion, an average of 3 year

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Blood sampleBIOLOGICAL

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.

LUPUS PATIENTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with systemic lupus

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tours, 37044, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Yanis RAMDANI

    CHRU de Tours

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanis RAMDANI

CONTACT

0234378919yanis.ramdani@univ-tours.fr

Valérie GOUILLEUX-GRUART

CONTACT

valerie.gouilleux@univ-tours.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 15, 2023

Study Start

July 21, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2030

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

FR(1)