This is a phase 2, pilot, randomized, placebo-controlled trial of Gamunex-C IVIG as
mono-therapy for HMGCoA reductase auto-antibody positive (HMGCR) necrotizing myopathy. The
trial will test the feasibility and initial efficacy of Gamunex-C IVIG mono-therapy in HMGCR
This is a phase 2, double-blinded, randomized, placebo-controlled, multi-center trial of
Gamunex-C IVIG as mono-therapy for HMGCR necrotizing myopathy. Up to 10 treatment-naïve
patients will be enrolled and randomized to receive either Gamunex-C IVIG dosed at 2g/kg or
placebo at week 0 and week 4. The primary efficacy outcome is the percentage of patients at
week 8 with at least minimal improvement per the 2016 ACR/EULAR myositis clinical response
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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