Low frequency glatiramer acetate therapy
A technology of glatiramer acetate and medicine, applied in the field of low-frequency glatiramer acetate therapy
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[0097] A multinational, multicenter, randomized, phase III parallel-group study in individuals with relapsing-remitting multiple sclerosis (RRMS) to evaluate 40 mg / ml administered by subcutaneous injection three times per week in a double-blind design Efficacy, safety and tolerability of glatiramer acetate (GA) injection versus placebo.
[0098] method:
[0099] The study was designed to select injections on 3 days a week. Three injections are given every 7 days, and there must be at least one day between each injection.
[0100] Study Duration:
[0101] ●Screening period: 1 month
[0102] ●Placebo Controlled (PC) period: for 12 months, 40mg / ml or matching placebo was administered by subcutaneous injection three times a week.
[0103] Open Label (OL) extension study: All subjects will continue treatment with 40 mg / ml GA administered three times a week until this dose is marketed for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) or until Deve...
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