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NOT YET RECRUITING
NCT07636655

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2026-06-01

Completion Date

2051-06-01

Last Updated

2026-06-11

Healthy Volunteers

No

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.

Locations (1)

CHU de Nantes

Nantes, Loire-atlantique, France