Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
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: systematic collection of additional biological samples (blood volume), BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index).
- Who it may be relevant to
- Registry conditions: Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies. Basic parameters: from 18 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 →
Official title
NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
Overview
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
- Other systematic collection of additional biological samples (blood volume)
systematic collection of additional biological samples (blood volume) - Diagnostic test BVAS (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, the
Primary outcome measures
- Identification of a CD8+ T-cell signature sensitive to B-cell depletion. [Time frame: From diagnosis up to 2 years after the final rituximab infusion]
Secondary outcome measures (3)
- To characterize the relationship between B-cell immune responses and CD8 T-cell responses in patients with ANCA-associated vasculitis. [Time frame: 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. [Time frame: 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. [Time frame: From diagnosis up to 2 years post-treatment.]
Eligibility criteria
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)
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
- Cohort
Study locations
France · 1 center
- CHU de Nantes — Nantes
Identifiers
NCT: NCT07636655 · RC19_0417 · 2026-A00620-51