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

June 4, 2026 updated by: Nantes University Hospital

NALVANCA: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Loire-atlantique
      • Nantes, Loire-atlantique, France, 44093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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, these instruments allow comprehensive evaluation of both disease activity and long-term patient outcomes in clinical trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From diagnosis up to 2 years after the final rituximab infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phenotypic and functional characterization of immune responses (B and T).
Time Frame: From diagnosis up to 2 years post-treatment.
Analysis of relationships between B-cell and CD8+ responses, identification of biomarkers (CD4+ T-cells, Treg, ILC, immunoglobulins), and correlations with clinical events (infections, cardiovascular complications).
From diagnosis up to 2 years post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

CR2TI - UMR1064 (INSERM)

Investigators

  • Principal Investigator: Nicolas Degauque, PhD, CR2TI - UMR1064 (INSERM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2051

Study Completion (Estimated)

June 1, 2051

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_0417
  • 2026-A00620-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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