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

NCT07636655 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-07-07

No results posted yet for this study

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

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, these instruments allow comprehensive evaluation of both disease activity and long-term patient outcomes in clinical trials.

Sponsors & Collaborators

  • CR2TI - UMR1064 (INSERM)

    collaborator UNKNOWN

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Nicolas Degauque, PhD · CR2TI - UMR1064 (INSERM)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2051-09-01
Completion
2051-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636655 on ClinicalTrials.gov