Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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).
Primary outcome measures
- Biomarker analysis of lupus nephritis activity - whole blood cell populations [Time frame: baseline]
- Biomarker analysis of lupus nephritis activity - blood cytokines [Time frame: baseline]
- Biomarker analysis of lupus nephritis activity - urine cytokines [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Cliniques universitaires Saint-Luc — Brussels
Identifiers
NCT: NCT05443516 · 2014/07AVR/170