Ruxolitinib Treatment in Inclusion Body Myositis

Ki vehet részt

• Age ≥ 45 years
• Effective contraception for the duration of the clinical trial for fertile women of childbearing age
• Defined diagnosis of IBM according to data-derived criteria (Llyod et al, 2014): Patient must fulfill the three following criteria for being diagnosed as IBM: (1) finger flexor or quadriceps weakness; and (2) muscle biopsy showing endomysial inflammation; and (3) muscle biopsy showing invasion of nonnecrotic muscle fibers or rimmed vacuoles
• To be able to walk 6 min without assistance from another person (external assist devices permitted [e.g., canes, walkers, or rollators])
• Patient informed and having signed the consent for participation, possibly assisted by a trusted person

Ki nem vehet részt

• Concomitant use of immunomodulatory drugs including previous treatment with JAK inhibitor, or medications acting on muscle anabolism or catabolism
• Live vaccine within the 4 weeks before starting treatment
• Necessity to use a drug incompatible with ruxolitinib
• Concomitant participation in another clinical trial on medical product for human use, to a clinical investigation on a medical device, to interventional study involving human participants or in the exclusion period at the end of a previous clinical trial on medical product for human use, a clinical investigation on a medical device, or study involving human participants; Participation in non-interventional research is permitted
• Patient with cognitive disorders or unable, according to the investigator, to understand the study and/or to give informed consent
• Comorbidity or active chronic disease which contraindicate ruxolitinib:; Lipid parameters abnormalities/elevations; Severe renal impairment (stage 4) and end-stage renal disease (stage 5); Hepatic impairment; Cytopenia; Recent history (<6 months) of cardiovascular or thromboembolic disease (documented coronaropathy or hospitalization for acute arterial thrombosis or stroke or deep venous thrombosis or pulmonary embolism); Active smoking more than 20 pack-years or history of respiratory or skin cancer or recent history (<6 months) of other neoplastic disease; Very high cardiovascular risk (red color) at SCORE 2 in case of recent history (<6 months) of cardiovascular or thromboembolic disease and non-controlled cardiovascular risk factors; History of Stevens-Johnson's syndrome or Lyell's syndrome
• Active SARS-CoV-2 infection (patient can be included once infection resolved)
• Any medical condition which limits the ability of participant to participate in study
• Hypersensitivity to the IMP's active substance (ruxolitinib) or to any of the excipients
• Pregnancy or breastfeeding
• Patient under guardianship, curatorship, safeguard of justice or deprived of liberty
• Quadriceps weakness (manual muscle testing, MRC) below or equal 1
• Forced vital capacity (FVC) or forced expiratory volume (FEV) < 50% of predicted value
• Non-affiliation to a social security scheme or to another social protection scheme, patient on state medical aid
• Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol