Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies

Phase 4Not Yet RecruitingNCT07668505

Chinese University of Hong Kong10 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥18 to \<80 years of age 2. Myositis disease onset \>18 years 3. Fulfillment of 2017 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) IIM classification criteria 4. 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. Exclusion Criteria: 1. Pregnancy or lactation, 2. Malignancy 3. Functional class 4 4. Contraindication to Maraviroc.

Outcomes

Primary Outcomes

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, extramuscular activity score. Minimal clinical improvement is defined by 3 of any of the 6 CSMs improved by ≥ 20%, with no more than 2 CSMs worsening by ≥ 25% (worsening measure cannot include the MMT-8). The response rate will be calculated by the Total Improvement Score (TIS) using the 2016 ACR/EULAR myositis response criteria.

Time frame: From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

Muscle histological features

Changes in muscle histological features analyzed on conchotome muscle biopsies, which will be performed at baseline and 12 weeks. Biopsies will be sectioned to examine the levels of perifascicular atrophy, inflammation, distribution and types of inflammatory cells (e.g., CD163, CD68 for monocytes/macrophages; CD4, CD8 for T cells; CD20 for B cells), degenerating/regenerating fibers, and fibrosis. We expect to observe a decreased level of inflammation, fibrosis, and fiber degeneration.

Time frame: From enrollment to the end of treatment at 12 weeks

Muscle oedema (inflammation) and fatty infiltration (damage)

Changes in muscle oedema (inflammation) and fatty infiltration (damage) detected by MRI of muscles will be obtained at baseline and 12 weeks. MRI images will be reviewed by a radiologist blinded to the clinical information of the patient.

Time frame: From enrollment to the end of treatment at 12 weeks

Levels of CCR5 and CCL5 expressions

Changes in the expression levels of CCR5 and CCL5 will be examined

Time frame: From enrollment to the end of treatment at 12 weeks

Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts