NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient unable to provide informed consent.
- •Patient refusing to participate in the study.
- •End-stage renal disease.
- •Progressive neoplasia (excluding cutaneous carcinomas)
研究组 & 干预措施
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.
干预措施: BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index) (Diagnostic Test)
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.
干预措施: systematic collection of additional biological samples (blood volume) (Other)