Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05443516

Acronym

JD001

Enrollment

250

Registered

2022-07-05

Start date

2014-06-16

Completion date

2032-12-31

Last updated

2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Countries

Belgium

Contacts

Primary ContactFrédéric Houssiau, Pr

frederic.houssiau@uclouvain.be+32 02 764 53 90

Backup ContactFarah Tamirou, Pr

farah.tamirou@uclouvain.be+32 02 764 53 87

Outcome results