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

Qualifiers

≥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

Treatments tested in this trial

  • maraviroc (Selzentry, Celsentri)

Treatment groups

10 Participants
are divided into 1 treatment group