Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
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Conditions studied: Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies
In brief
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.
Key facts
- Study ID
- NCT07636655
- Run by
- Nantes University Hospital
- People needed
- 120
- Starts
- 2026-09-01
- Expected to finish
- 2051-09-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- CHU de Nantes — Nantes, Loire-atlantique, France
Full record on ClinicalTrials.gov
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