Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

Lupus Nephritis Clinical Trial

— JD001  

Official title:

Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus. Recherche de Biomarqueurs de l'activité de la Maladie Chez Des Patients Atteints de Lupus érythémateux disséminé.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443516
• Other study ID #: 2014/07AVR/170
• Status: Recruiting
• Start date: June 16, 2014
• Est. completion date: December 31, 2032

Study information

• Verified date: June 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Frédéric Houssiau, Pr
• Phone: +32 02 764 53 90
• Email: frederic.houssiau[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker analysis of lupus nephritis activity - whole blood cell populations	whole blood cell populations - flow cytometry assay	baseline
Primary	Biomarker analysis of lupus nephritis activity - blood cytokines	blood cytokines - flow cytometry assay	baseline
Primary	Biomarker analysis of lupus nephritis activity - urine cytokines	urine cytokines - flow cytometry assay	baseline