Идёт набор NCT06544343

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy

Без фазы С лечением Rheumatoid Arthritis Psoriatic Arthritis Systemic Lupus Erythematosus Systemic Sclerosis

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: Remote Monitoring, On site monitoring.
Кому может быть актуально: Состояния в реестре: Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis. Базовые параметры: Без ограничений · 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 →

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Официальное название

Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy in Patients With Rheumatologic Diseases: Comparison With Standard Management

Обзор

Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged, often lifelong, and is essential to keep the disease under control, thus reducing the risk of complications and allowing the best possible quality of life for patients. The drugs used for treating these diseases are mostly immunosuppressants, which reduce the activity of the immune system, whose alteration is responsible for the disease. Although all available drugs are effective for treating these diseases, for reasons largely unknown, each drug is effective only in a percentage of patients. As a result, it is often necessary to try several different treatments before identifying an effective one for the individual patient. The therapeutic effects are often slow, and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined. The initial period is also when side effects most often appear. The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence, response, and quality of life for the patient.

Вмешательства

Другое Remote Monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
Другое On site monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.

Первичные конечные точки

Treatment persistence [Срок оценки: 6 months]

Вторичные конечные точки (12)

Treatment Persistence [Срок оценки: 3 months]
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP) [Срок оценки: 3 months]
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP) [Срок оценки: 6 months]
Psoriatic Arthritis Disease Activity Score (PASDAS) [Срок оценки: 3 months]
Psoriatic Arthritis Disease Activity Score (PASDAS) [Срок оценки: 6 months]
Body Surface Area (BSA) [Срок оценки: 3 months]
Body Surface Area (BSA) [Срок оценки: 6 months]
Minimal Disease Activity (MDA) [Срок оценки: 3 months]
Minimal Disease Activity (MDA) [Срок оценки: 6 months]
Modified Rodnan's skin score [Срок оценки: 3 months]
Modified Rodnan's skin score [Срок оценки: 6 months]
Medical Research Council (MRC) dyspnoea scale [Срок оценки: 3 months]

Критерии участия

Критерии включения

Any patient with one of the following conditions

Rheumatoid Arthritis
Psoriatic Arthritis
Spondyloarthritis
Ankylosing Spondylitis
Systemic Sclerosis
Systemic Lupus Erythematosus
Sjogren's Disease who are prescribed a new immunosuppressive medication for the treatment of their disease among the following:
Methotrexate
Sulfasalazine
Leflunomide
Mycophenolate Mofetil
Azathioprine
Cyclosporine A
Tacrolimus
TNF inhibitors (etanercept, adalimumab, golimumab, certolizumab pegol)
IL6 inhibitors (tocilizumab)
IL-17 inhibitors (secukinumab, ixekizumab)
IL-23 inhibitors (ustekinumab, guselkumab, risankizumab)
JAK-inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib)
Belimumab
Anifrolumab