Genmab — Oktober 2014
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Time to sustained remission on minimal steroid therapy [ Time Frame: Up to 60 weeks ] [ Designated as safety issue: No ]
Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintained a dose <=10 mg/day with no new or nonhealing (established) lesions for >=8 weeks and maintained the status until Week 60 will be assessed -
MIRROR: Threshold Identified for Ofatumumab Therapy in MS
Results of the phase 2 study suggest that an optimal dose can be found that will give maximal suppression of MS lesions without completely eradicating all B cells.
Medscape (www.medscape.com)
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Presenting the new analysis at the American Academy of Neurology (AAN) 66th Annual Meeting, Daren Austin, PhD, from GSK UK, explained that the study included a large range of doses in an attempt to pinpoint the lowest dose for significantly reducing MRI lesion activity.
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For the MIRROR study, 231 patients with relapsing-remitting MS were randomly assigned to 1 of 4 doses of ofatumumab or placebo. The 4 doses were 3 mg every 12 weeks, 30 mg every 12 weeks, 60 mg every 12 weeks, and 60 mg every 4 weeks. After 12 weeks, the placebo group received 3 mg of ofatumumab. The study treatments were given for 24 weeks. The primary endpoint was suppression of MRI lesion activity during the first 12 weeks.
Results suggested a 90% or greater reduction in the cumulative numbe
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Safety fra MIRROR...There were no unexpected safety findings in the study, the company reports. Between weeks 0 and 12, injection-related reactions were the most common adverse reaction, seen in 52% of patients receiving ofatumumab vs 15% of those receiving placebo. Five serious adverse events were reported, all in patients receiving the 60-mg dose, but none of these patients withdrew from the study.
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