Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies
Conditions
Keywords
ANCA, AAV
Brief summary
ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation. However, identifying patients at high risk of relapse remains a challenge, often leading to unnecessarily long treatments and side effects. Recent research suggests that RTX also impacts CD8+ T-cells, which could serve as valuable markers for better disease monitoring. The main goal of the NALVANCA cohort is to identify biomarkers within these CD8+ T-cells. Researchers aim to find biological signals that respond to treatment and can predict a relapse. By studying these markers at the start of therapy and during the immune recovery phase, the study hopes to personalize treatment duration and management for each patient. Recruitment targets adult patients diagnosed with ANCA-associated vasculitis. Participants must provide written informed consent for the use and storage of their blood samples in a biocollection. The protocol involves long-term monitoring with regular sampling to track changes in immune cells alongside the patient's clinical health.
Interventions
OTHERsystematic collection of additional biological samples (blood volume)
systematic collection of additional biological samples (blood volume)
DIAGNOSTIC_TESTBVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)
BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index) are standardized clinical assessment tools used in vasculitis studies. BVAS is a physician-reported score that evaluates current disease activity across organ systems, capturing the presence and severity of active vasculitic manifestations. In contrast, VDI measures accumulated and irreversible organ damage resulting from vasculitis and/or its treatment over time, irrespective of current disease activity. Together, these instruments allow comprehensive evaluation of both disease activity and long-term patient outcomes in clinical trials.
Sponsors
Nantes University Hospital
CR2TI - UMR1064 (INSERM)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Adult patient (age ≥ 18 years). * Patient affiliated with the French social security system. * Seropositive ANCA-associated vasculitis (AAV) (positive for anti-PR3 or anti-MPO) meeting the Chapel-Hill classification criteria. * Patient scheduled to receive rituximab (RTX) maintenance therapy (500 mg every 6 months) following an initial flare or a relapse of the disease.
Exclusion criteria
* Patient unable to provide informed consent. * Patient refusing to participate in the study. * End-stage renal disease. * Progressive neoplasia (excluding cutaneous carcinomas)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of a CD8+ T-cell signature sensitive to B-cell depletion. | From diagnosis up to 2 years after the final rituximab infusion | Identification of a CD8+ T-cell biomarker demonstrating dual sensitivity: during rituximab-induced depletion (pre- vs. post-RTX comparison) and during immune reconstitution (comparison of samples under treatment vs. 2 years post-treatment or at relapse). |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the relationship between B-cell immune responses and CD8 T-cell responses in patients with ANCA-associated vasculitis. | From diagnosis up to 2 years post-treatment. |
| To identify potential immune biomarkers associated with disease phenotype and outcomes, including CD4 T-cell subsets, regulatory T cells (Tregs), innate lymphoid cells, immunoglobulins, and inflammatory markers. | From diagnosis up to 2 years post-treatment. |
| To evaluate the association between lymphocyte-related immune biomarkers and the occurrence of intercurrent clinical events, including infectious and cardiovascular complications. | From diagnosis up to 2 years post-treatment. |
Countries
France
Contacts
CONTACTAntoine Néel, Pr
PRINCIPAL_INVESTIGATORNicolas Degauque, PhD
CR2TI - UMR1064 (INSERM)
Outcome results
None listed