Идёт набор NCT07571993

Rheumatoid Arthritis Remission Screening and Prospective Surveillance

— Наблюдательное Rheumatoid Arthritis

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Rheumatoid Arthritis. 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: Италия
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

Rheumatoid Arthritis Remission Screening and Prospective Surveillance (HARMONICS)

Обзор

HARMONICS is a prospective registry embedded in the routine clinical practice of the Early Arthritis Clinic and the Prospective Remission Clinic at Fondazione IRCCS Policlinico San Matteo, with an associated research biorepository of voluntarily donated biological samples. It is designed to collect and generate long-term longitudinal data from patients with early-treated rheumatoid arthritis (RA) who have achieved stable clinical remission with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and undergo treatment tapering or discontinuation according to local care pathways, following shared decision-making between the patient and the treating rheumatologist. Following enrollment in stable clinical remission, patients are monitored as part of standard of care at regular intervals using clinical, ultrasound, and radiographic assessments to evaluate disease activity and outcomes. Treatment modifications, including tapering, discontinuation, and re-treatment, are recorded longitudinally. Participants are followed in the registry from enrollment for up to 60 months, unless a disease flare occurs earlier. Patients experiencing a disease flare within the initial 60-month follow-up period undergo an additional 12 months of follow-up after flare. The registry aims to provide a comprehensive longitudinal framework of multimodal data to advance the clinical and pathophysiological understanding of remission phenotypes and natural disease trajectories, with the ultimate goals of: * optimizing risk stratification and therapeutic decision-making in patients with RA in remission; and * identifying and exploring novel targets for potential transformative therapies.

Первичные конечные точки

Longitudinal disease control [Срок оценки: From enrollment to 24 months of follow-up]

Вторичные конечные точки (4)

Time-to-flare of rheumatoid arthritis activity [Срок оценки: From enrollment up to 60 months of follow-up.]
Longitudinal changes in clinical, ultrasound-derived, and biological variables [Срок оценки: From enrollment up to 24 months of follow-up]
Clinical and ultrasound response following treatment escalation or re-treatment due to arthritis flare [Срок оценки: At 6 and 12 months after treatment escalation or re-treatment]
Comorbidity burden during follow-up [Срок оценки: From enrollment up to 60 months of follow-up.]

Критерии участия

Критерии включения

Age ≥18 years
Diagnosis of RA fulfilling the ACR/EULAR 2010 or ACR 1987 classification criteria within 12 months of first evaluation at the Early Arthritis Clinic
Initiation of csDMARD therapy within 12 months of symptom onset
Continuous treatment with csDMARDs for ≥24 months
No prior or current treatment with biologic or targeted synthetic DMARDs
DAS28-ESR <2.6 for ≥6 months in the absence of glucocorticoid therapy
Management with a treatment tapering or discontinuation strategy with planned monitoring as part of routine clinical care, following shared decision-making with the treating rheumatologist
Ability to provide written informed consent for participation in the registry