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NCT Number: NCT07636655

Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis

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.

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Key information

Conditions

Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

systematic collection of additional biological samples (blood volume)

Other

systematic collection of additional biological samples (blood volume)

BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)

Diagnostic Test

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.

Primary outcomes

  1. 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

    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 outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

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

Antoine Néel, Pr

CONTACT

[email protected]

+33.2.40.08.33.55

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • CR2TI - UMR1064 (INSERM)

Registry information

Official study title

NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis

Acronym: NALVANCA

Important dates

Study start
2026
Primary completion
2051
Study completion
2051
First posted
Jun 9, 2026
Registry last updated
Jul 7, 2026

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.