Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis (NALVANCA)
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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Antoine Néel, Pr
- 電話番号：+33.2.40.08.33.55
- メール：antoine.neel@chu-nantes.fr
研究場所
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Loire-atlantique
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Nantes、Loire-atlantique、フランス、44093
- CHU de NANTES
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コンタクト：
- Antoine Néel, Pr
- 電話番号：+33.2.40.08.33.55
- メール：antoine.neel@chu-nantes.fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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.
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systematic collection of additional biological samples (blood volume)
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Identification of a CD8+ T-cell signature sensitive to B-cell depletion.
時間枠：From diagnosis up to 2 years after the final rituximab infusion
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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).
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From diagnosis up to 2 years after the final rituximab infusion
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Phenotypic and functional characterization of immune responses (B and T).
時間枠：From diagnosis up to 2 years post-treatment.
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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).
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From diagnosis up to 2 years post-treatment.
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協力者と研究者
捜査官
- 主任研究者：Nicolas Degauque, PhD、CR2TI - UMR1064 (INSERM)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RC19_0417
- 2026-A00620-51 (その他の識別子：ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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