Идёт набор NCT06609668

Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)

— Наблюдательное Giant Cell Arteritis (GCA) Polymyalgia Rheumatica (PMR)

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: Additional blood samples.
Кому может быть актуально: Состояния в реестре: Giant Cell Arteritis (GCA), Polymyalgia Rheumatica (PMR). Базовые параметры: от 50 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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Обзор

Polymyalgia rheumatica (PMR) is a rheumatologic condition occurring in patients \> 50 years old, characterized by inflammatory pain of the scapular (shoulder) and pelvic (hip) girdles. PMR is most often isolated but can be associated with giant cell arteritis (GCA), a large vessels vasculitis, in 16 to 21% of case. The main features of GCA are headaches, jaw claudication, visual disturbances, abnormal temporal artery, scalp tenderness associated to elevated CRP and/or ESR. However, GCA could be asymptomatic in particular in case of isolated involvement of large vessels (subclinical GCA). GCA requires high doses of glucocorticoids, compared to isolated PMR, to avoid complications resulting from vascular remodeling (stroke, blindness). Ruling out GCA in PMR patients relies on the performance of some complementary exams that explore cranial vessels as color doppler ultrasound and/or temporal artery biopsy and large vessels that relies on PET/FDG or angio CT scan. The aim of this study is to identifie serum biomarkers that could rule out or identifies GCA in patients with PMR features. Ultimately, if biomarkers are identified, this could allow to select PMR patients in whom complementary exams are needed or not. For this study, investigators chose to explore thrombomodulin. Thrombomodulin is a protein that is increased in the circulating blood during vascular inflammation, and therefore seems to be a good candidate for distinguish isolated PMR from PMR associated with GCA.

Вмешательства

Биопрепарат Additional blood samples
* 1 dry tube (5 mL) * 1 EDTA tube (6 mL) Performed at inclusion (before any glucocorticoid and/or immunosuppressive treatment) and at follow-up visit (3 months after inclusion)

Первичные конечные точки

Measurement of serum thrombomodulin concentrations by Luminex at diagnosis (prior to any glucocorticoid treatment) [Срок оценки: At baseline]

Критерии участия

Критерии включения

Patient who has given oral consent
Patient > 50 years of age

Patients with PPR, meeting ACR/EULAR 2012 criteria:

age > 50 years at onset of symptoms
inflammatory limb-girdle pain
elevated ESR (>20 mm/hr) and/or CRP (> 10 mg/l)
AND Score ≥ 4 points among

Morning stiffness > 45 minutes (2 pts)
Hip pain or limitation of amplitude (1 pt)
Rheumatoid factor or anti-CCP antibodies negative (2 pts)
Absence of other joint pain (1 pt)

Критерии исключения

Patient not affiliated to national health insurance
Patient under legal protection (curatorship, guardianship)
Patient subject to a measure of legal safeguard
Pregnant or breast-feeding women
Adult patient unable to provide consent
Patient having received corticosteroid or immunosuppressive treatment in the month prior to inclusion
Patient with a contraindication to corticosteroid therapy
Patients with an active infection, neoplasia or other inflammatory/autoimmune condition
Patients with late onset rheumatoid arthritis.
Conditions rendering vascular imaging unfeasible or uninterpretable:
For angio-CT: allergy to iodine, renal failure (CKD <30 mL/min)
For PET scan: unbalanced diabetes NB: only one of the two vascular imaging techniques will be performed, depending on the patient\'s condition and the technical resources available.

Secondary exclusion criteria: