Идёт набор NCT05364892

Biocollection of Patients With ANCA Associated Vasculitis

Без фазы С лечением ANCA-associated Vasculitis

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: Blood samples (80 mL), Fecal samples, Urinary sample (20-40 mL), Questionnaires.
Кому может быть актуально: Состояния в реестре: ANCA-associated Vasculitis. Базовые параметры: 18 лет — 99 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Biocollection of Patients With ANCA Associated Vasculitis Diagnosed Within the CERAINO Autoimmune Disease Reference Center, Part of the Global BRAISE Project (B-dependent Rare AutoImmune DiseaSES

Обзор

As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.

Подробное описание

Vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA) is a group of rare and severe autoimmune diseases, encompassing several entities: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (PMA), and eosinophilic granulomatosis with polyangiitis (GEPA). When untreated, these diseases are fatal in a matter of months. Currently, thanks to the use of corticosteroids and immunosuppressants, this high mortality has greatly decreased and these are now chronic diseases. On the other hand, these patients are at high risk of morbidity, linked to both relapses (occurring in at least 50% of patients) and side effects of treatments. It is therefore essential to be able to define which patients are at risk of relapse and justify long-term immunosuppressive treatment to avoid recurrence of the disease, and conversely which patients have a low risk of relapse and in whom immunosuppressive treatments can be discontinued to limit the risk of side effects. However, so far no predictor or biomarker can accurately assess this risk of relapse.

Вмешательства

Другое Blood samples (80 mL)
Blood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment
Другое Fecal samples
Fecal samples at inclusion
Другое Urinary sample (20-40 mL)
Urinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment
Другое Questionnaires
Questionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment

Первичные конечные точки

Relapse-free survival of the disease [Срок оценки: Five years after diagnosis]

Вторичные конечные точки (10)

death [Срок оценки: Five years after diagnosis]
Age [Срок оценки: Five years after diagnosis]
Sex [Срок оценки: Five years after diagnosis]
Physician assessment of disease activity [Срок оценки: Five years after diagnosis]
Patient assessment of disease activity [Срок оценки: Five years after diagnosis]
BVAS score - Birmingham Vasculitis Activity Score [Срок оценки: Five years after diagnosis]
VDI score - Vasculitis Damage Index [Срок оценки: Five years after diagnosis]
Number of patients with refractory character of the Vasculitis [Срок оценки: Five years after diagnosis]
HAQ-DI - Health Assessment Questionnaire - Disability Index. [Срок оценки: Five years after diagnosis]
Glucocorticoid toxicity index - Glucocorticoid toxicity index during follow-up Glucocorticoid toxicity index [Срок оценки: Five years after diagnosis]

Критерии участия

Критерии включения

Major patients with no upper age limit.
Patients assessed as part of the reference centre for rare autoimmune diseases at the CHRU in Brest.
Patients for whom a diagnosis of ANCA-associated vasculitis is made by the physician in charge of the patient, according to the definitions of the Chapel-Hill Consensus Conference.
Patient affiliated with Social Security
Patient who has signed written informed consent