NCT03896373

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

March 27, 2019

Last Update Submit

February 23, 2021

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

  • Expression of FcRn in active or newly diagnosed lupus erythematosus compared with inactive lupus erythematosus

    Measurement in flow cytometry of the fluorescence's mean of FcRn in each type of white blood cells

    At baseline

Secondary Outcomes (4)

  • FcRn genotyping (FCGRT)

    At baseline

  • IGHG1 genotyping

    At baseline

  • Expression of FcRn in CD16 monocytes

    At baseline

  • Expression of FcRn in macrophages

    At baseline

Study Arms (1)

Lupus erythematosus

Patients with inactive lupus erythematosus, active lupus erythematosus or newly diagnosed

Other: Blood samples

Interventions

Blood samplesOTHER

Blood samples

Lupus erythematosus

Eligibility Criteria

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

All patient included are hospitalised in the university hospital of Tours in France

You may qualify if:

  • Lupus erythematosus newly diagnosed or active
  • Inactive lupus erythematosus
  • Needing a blood sample for diagnosis or follow up
  • Signed informed consent

You may not qualify if:

  • Other auto immune disease
  • Pregnant or brest feeding
  • Legal protection or protected adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Internal Medicine Service, University Hospital, Tours

Tours, 37044, France

Location

Nephrology Service, University Hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from patients

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

  • Valérie GOUILLEUX, PhD

    University Hospital, Tours

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 1, 2019

Study Start

April 17, 2019

Primary Completion

October 18, 2020

Study Completion

October 18, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

FR(2)