Набор скоро начнётся NCT07636655

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

— Наблюдательное Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: systematic collection of additional biological samples (blood volume), BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index).
Кому может быть актуально: Состояния в реестре: Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое systematic collection of additional biological samples (blood volume)
systematic collection of additional biological samples (blood volume)
Диагностический тест 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, the

Первичные конечные точки

Identification of a CD8+ T-cell signature sensitive to B-cell depletion. [Срок оценки: From diagnosis up to 2 years after the final rituximab infusion]

Вторичные конечные точки (3)

To characterize the relationship between B-cell immune responses and CD8 T-cell responses in patients with ANCA-associated vasculitis. [Срок оценки: From diagnosis up to 2 years post-treatment.]
To identify potential immune biomarkers associated with disease phenotype and outcomes, including CD4 T-cell subsets, regulatory T cells (Tregs), innate lymphoid cells, immunoglobulins, and inflammatory markers. [Срок оценки: From diagnosis up to 2 years post-treatment.]
To evaluate the association between lymphocyte-related immune biomarkers and the occurrence of intercurrent clinical events, including infectious and cardiovascular complications. [Срок оценки: From diagnosis up to 2 years post-treatment.]

Критерии участия

Критерии включения

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.