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Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

Recruiting
Conditions
Lupus Nephritis
Registration Number
NCT05443516
Lead Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brief Summary

The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.

Detailed Description

The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease.

In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
250
Inclusion Criteria
  • Fulfilment of the EULAR/ACR classification criteria of SLE.
  • 18 years of age or above.
  • Incident or Flare biopsy-proven proliferative or membranous LN
Exclusion Criteria
  • Antiphospholipid syndrome nephropathy (APSN).
  • Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
  • Anticipated non-adherence to therapy.
  • Medical conditions interfering with outcome evaluations.
  • Inability to read and/or sign the informed consent form.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Biomarker analysis of lupus nephritis activity - whole blood cell populationsbaseline

whole blood cell populations - flow cytometry assay

Biomarker analysis of lupus nephritis activity - blood cytokinesbaseline

blood cytokines - flow cytometry assay

Biomarker analysis of lupus nephritis activity - urine cytokinesbaseline

urine cytokines - flow cytometry assay

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc

🇧🇪

Bruxelles, Belgium

Cliniques universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Farah Tamirou, Dr
Contact
+32 02 764 53 87
farah.tamirou@uclouvain.be

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