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

NCT07636655 | Not Yet Recruiting

• 2 other identifiers: RC19_04172026-A00620-51
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies

Keywords

ANCA; AAV

Outcome Measures

Primary Outcomes (1)

• Identification of a CD8+ T-cell signature sensitive to B-cell depletion.

  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).

  From diagnosis up to 2 years after the final rituximab infusion

Secondary Outcomes (3)

• 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.

Study Arms (1)

NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab.

This cohort follows adult patients with ANCA-associated vasculitis, a systemic autoimmune disease. The intervention of interest is Rituximab (RTX) therapy, used to induce B-cell depletion. The study involves longitudinal monitoring with the systematic collection of biological samples at key time points: before treatment induction, during the depletion phase, and upon immune reconstitution (2 years after the last injection or at relapse). The objective is to study the pleiotropic effects of B-cell depletion on CD8+ T-cells to identify biomarkers capable of predicting the risk of relapse.

Other: systematic collection of additional biological samples (blood volume); Diagnostic Test: BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)

Interventions

systematic collection of additional biological samples (blood volume) OTHER

systematic collection of additional biological samples (blood volume)

NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab.

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.

NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults treated in Nantes, Saint-Nazaire, or La Roche-sur-Yon for ANCA-associated vasculitis (GPA or MPA). These patients, positive for anti-PR3 or anti-MPO antibodies, are recruited during a flare or relapse and receive Rituximab therapy. Samples are provided by the NALVANCA Biocollection.

You may qualify if:

• 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.

You may not qualify if:

• Patient unable to provide informed consent.
• Patient refusing to participate in the study.
• End-stage renal disease.
• Progressive neoplasia (excluding cutaneous carcinomas)

Sponsors & Collaborators

• Nantes University Hospital: lead
• CR2TI - UMR1064 (INSERM): collaborator

Study Sites (1)

CHU de Nantes

Nantes, Loire-atlantique, 44093, France

Location

MeSH Terms

Interventions

Blood Volume

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemodynamics; Cardiovascular Physiological Phenomena

Study Officials

• Nicolas Degauque, PhD

  CR2TI - UMR1064 (INSERM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Néel, Pr

CONTACT

+33.2.40.08.33.55; antoine.neel@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2051
• Study Completion (Estimated): June 1, 2051
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

FR (1)