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Not yet recruiting NCT07251179

Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

— Observational Systemic Lupus Erythematosus Systemic Scleroderma ANCA-associated Vasculitis Antiphospholipid Syndrome

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
The protocol lists: blood draw.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis, Antiphospholipid Syndrome. 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
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results: i) the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive/pathogenic B cells using high-throughput flow cytometry in several clinical situations.

Interventions

  • Biological blood draw
    blood draw

Primary outcome measures

  • Study of the percentage of autoreactive LB / tetrameric LB+ [Time frame: inclusion visit]

Eligibility criteria

Inclusion criteria

  • Patients aged between 18 and 70
  • Patients for whom at least one of the following conditions has been confirmed:
  • Systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria.
  • Systemic scleroderma meeting the 2013 ACR/EULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR/ACR classification criteria.
  • Antiphospholipid syndrome according to the 2023 ACR/EULAR criteria.
  • Primary immunodeficiencies according to IUIS criteria.
  • Patients capable of understanding the objectives of the research.
  • Patients affiliated with a social security health insurance scheme (beneficiary or dependant).
  • Patients who have signed and dated the informed consent form for non-identifying genetic testing.

Exclusion criteria

  • Patient refusing to participate in the study
  • Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)
  • Patient under legal protection
  • Patient under guardianship or conservatorship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT07251179 · 9942

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗