Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus (JD001)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lupus Nephritis

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).

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Frédéric Houssiau, Pr; Phone Number: +32 02 764 53 90; Email: frederic.houssiau@uclouvain.be
• Study Contact Backup: Name: Farah Tamirou, Pr; Phone Number: +32 02 764 53 87; Email: farah.tamirou@uclouvain.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Farah Tamirou, Dr; Phone Number: +32 02 764 53 87; Email: farah.tamirou@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Incident or Flare biopsy-proven proliferative or membranous LN diagnosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Systemic Lupus Erythematosus - Lupus Nephritis Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker analysis of lupus nephritis activity - whole blood cell populations	whole blood cell populations - flow cytometry assay	baseline
Biomarker analysis of lupus nephritis activity - blood cytokines	blood cytokines - flow cytometry assay	baseline
Biomarker analysis of lupus nephritis activity - urine cytokines	urine cytokines - flow cytometry assay	baseline

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Frédéric Houssiau, Pr, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: 2014/07AVR/170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No