Набор скоро начнётся NCT07668505

Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies

Фаза IV С лечением Myositis

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: maraviroc (Selzentry, Celsentri).
Кому может быть актуально: Состояния в реестре: Myositis. Базовые параметры: 18 лет — 80 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: Гонконг
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

A Novel Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies

Обзор

The goal of this clinical trial is to learn if the drug Maraviroc works to treat refractory idiopathic inflammatory myopathy (myositis) in patients who have not responded well to traditional therapies. It will also learn about how the drug affects muscle inflammation and function. The main questions it aims to answer are: Does Maraviroc reduce inflammation in the muscles? Does Maraviroc improve patients' muscle function and overall clinical symptoms? This is an open-label study, meaning researchers will give Maraviroc to all participants (there is no placebo) to see if the drug works to treat refractory myositis. Participants will: Take a 300mg Maraviroc tablet every day for 12 weeks. Undergo exams and tests with their doctors to check their muscle function, symptom improvement, and specific health markers (like enzyme levels).

Подробное описание

Objective:

This is an open-label clinical trial using Maraviroc for the treatment of refractory idiopathic inflammatory myopathy (myositis).

The hypothesis to be tested:

Findings from our pilot study demonstrate that Maraviroc has an anti-inflammatory effect in both dystrophic and aging muscle. We thus hypothesize that Maraviroc can be used for treating patients with refractory myositis by repressing the inflammation in muscles.

Design and subjects:

10 patients with refractory myositis who do not respond well to traditional therapy will be recruited for the clinical trial. The patients will receive Maraviroc tablets 300mg daily for 12 weeks of treatment, and their myositis-related manifestations will be examined to evaluate the treatment effect.

Main outcome measures:

The primary outcome for the trial will be the IMACS definition of minimal clinical improvement (DOI). IMACS defined the 2016 ACR/EULAR criteria for clinical response based on 6 core set measurements (CSMs), including physician global activity, patient global activity, MMT-8, health assessment questionnaire, enzymes, and extramuscular activity score. The total improvement score is the sum of all 6 improvement scores of each core set measure.

Expected results:

The Maraviroc treatment is expected to reduce inflammation in muscles and improve muscle function in patients.

Вмешательства

Препарат maraviroc (Selzentry, Celsentri)
The first study of repurposing Maraviroc for the treatment of myositis

Первичные конечные точки

IMACS definition of minimal clinical improvement (DOI) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (3)

Muscle histological features [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Muscle oedema (inflammation) and fatty infiltration (damage) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Levels of CCR5 and CCL5 expressions [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

≥18 to <80 years of age
Myositis disease onset >18 years
Fulfillment of 2017 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) IIM classification criteria
Active myositis defined as Manual Muscle Testing 8 (MMT8) score <142 with at least two other abnormal International Myositis Assessment \& Clinical Studies Group (IMACS) core set measures (Visual Analogue Scale (VAS) of patient global activity ≥2 cm, physician's global disease activity ≥2 cm, at least one muscle enzyme >1.5 times upper limit of normal, Health ssessment Questionnaire(HAQ) ≥0.25), despite 2 additional immunosuppressive treatments on top of glucocorticoids.