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NCT Number: NCT05443516

Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

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.

Recruiting

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Biomarker analysis of lupus nephritis activity - whole blood cell populations

    Time frame: baseline

    whole blood cell populations - flow cytometry assay

  2. Biomarker analysis of lupus nephritis activity - blood cytokines

    Time frame: baseline

    blood cytokines - flow cytometry assay

  3. Biomarker analysis of lupus nephritis activity - urine cytokines

    Time frame: baseline

    urine cytokines - flow cytometry assay

Study contacts

Contact information is provided by the study sponsor or research team.

Farah Tamirou, Pr

CONTACT

[email protected]

+32 02 764 53 87

Frédéric Houssiau, Pr

CONTACT

[email protected]

+32 02 764 53 90

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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.

Acronym: JD001

Important dates

Study start
2014
Primary completion
2022
Study completion
2032
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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