Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies
ConditionMyositis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese University of Hong Kong
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
Pregnancy or lactation,
Malignancy
Functional class 4
Contraindication to Maraviroc.
Trial design
Design model
Single group
Treatments tested in this trial
maraviroc (Selzentry, Celsentri)
DrugThe first study of repurposing Maraviroc for the treatment of myositis
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Maraviroc groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeksSponsors and contacts
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Source ClinicalTrials.gov
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