The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy

Exclusion Criteria

• •Oral glucocorticoid (GC) daily dose \> 15mg at screening
• •Change in oral GC dose \< 2 weeks prior to screening
• •Prior IVIG treatment for anti-HMGCR IMNM
• •-\>1 oral conventional synthetic DMARD (e.g. methotrexate, mycophenolate mofetil, azathioprine) use at screening
• •Change in concomitant DMARD dose \< 4 weeks prior to screening
• •Rituximab \< 6 months prior to screening
• •Plasma exchange, cyclophosphamide, or biologic immunosuppressive medication \< 3 months prior to screening
• •Use of statin medication at screening
• •History of anaphylactic reaction to IVIG
• •History of angina pectoris, myocardial infarction, transient ischemic attack, or stroke \< 12 months prior to screening
• •Females of child-bearing potential who are pregnant, breastfeeding, or are unwilling to practice a highly effective method of contraception during the study
• •Wells Criteria for DVT score of 2 or more at screening
• •Wells Criteria for PE score of 4 or more at screening
• •Weight \>120kg
• •History of cancer (excluding non-melanomatous skin cancer) \< 5 years prior to screening
• •History of pulmonary embolism or deep venous thromboembolism \< 3 years prior to screening
• •History of hyperviscosity or hypercoagulable state
• •Currently receiving anti-coagulation therapy (vitamin K antagonists, non-vitamin K oral anticoagulants \[e.g. dabigatran, rivaroxaban, apixaban\], parenteral anticoagulants \[e.g. fondaparinux\]. Note that oral anti-platelet agents are allowed (e.g. aspirin, clopidogrel, ticlopidine).
• •Glomerular filtration rate (GFR) \<60mL/min at the time of screening
• •Any medical condition which, in the investigator's judgment, makes participation in the clinical trial unadvisable or which would interfere with evaluation of the study treatment.