Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.

@article{Gold2012PlacebocontrolledP3,
  title={Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.},
  author={R. Gold and L. Kappos and D. Arnold and A. Bar-Or and G. Giovannoni and K. Selmaj and C. Tornatore and M. Sweetser and Minhua Yang and S. Sheikh and K. Dawson},
  journal={The New England journal of medicine},
  year={2012},
  volume={367 12},
  pages={
          1098-107
        }
}
BACKGROUND BG-12 (dimethyl fumarate) was shown to have antiinflammatory and cytoprotective properties in preclinical experiments and to result in significant reductions in disease activity on magnetic resonance imaging (MRI) in a phase 2, placebo-controlled study involving patients with relapsing-remitting multiple sclerosis. METHODS We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly… Expand
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
TLDR
In patients with relapsing-remitting multiple sclerosis, BG-12 (at both doses) and glatiramer acetate significantly reduced relapse rates and improved neuroradiologic outcomes relative to placebo. Expand
Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing–remitting multiple sclerosis: subgroup analyses of the DEFINE study
TLDR
Oral BG-12 significantly reduced the proportion of patients relapsed, the annualized relapse rate (ARR), and confirmed disability progression at two years compared with placebo in patients with relapsing–remitting multiple sclerosis and in all patient subgroups. Expand
Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing–remitting multiple sclerosis: subgroup analyses of the CONFIRM study
TLDR
The results of these analyses indicate that treatment with BG-12 is effective on relapses across a broad range of patients with relapsing–remitting multiple sclerosis with varied demographic and disease characteristics. Expand
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TLDR
Dimethyl fumarate treatment was associated with a reduction in magnetic resonance imaging activity in pediatric patients; pharmacokinetic and safety profiles were consistent with those in adults. Expand
Oral BG-12 (dimethyl fumarate) for relapsing–remitting multiple sclerosis: a review of DEFINE and CONFIRM
TLDR
Findings from the pivotal Phase III studies support BG-12 as a potential initial oral treatment for patients with RRMS or as an alternative to other currently available therapies. Expand
Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial
TLDR
The safety and efficacy of ozanimod versus interferon beta-1a in individuals with relapsing multiple sclerosis was confirmed and incidents of infections and serious treatment-emergent adverse events were similar across treatment groups. Expand
A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries
TLDR
The strong efficacy and favorable benefit-risk profile of DMF extends to Japanese, and more broadly, East Asian patients with RRMS. Expand
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Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
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In patients with relapsing-remitting multiple sclerosis, BG-12 (at both doses) and glatiramer acetate significantly reduced relapse rates and improved neuroradiologic outcomes relative to placebo. Expand
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Both doses of oral fingolimod improved the relapse rate, the risk of disability progression, and end points on MRI and were superior to placebo with regard to MRI-related measures. Expand
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This trial showed the superior efficacy of oral fingolimod with respect to relapse rates and MRI outcomes in patients with multiple sclerosis, as compared with intramuscular interferon beta-1a. Expand
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Natalizumab reduced the risk of the sustained progression of disability and the rate of clinical relapse in patients with relapsing multiple sclerosis and hold promise as an effective treatment for relapsed multiple sclerosis. Expand
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The magnitude of ABT-874 efficacy was less than that observed with other agents currently in development for MS treatment, and anti-IL-12/23 monotherapy does not appear to warrant further testing as monotherapy treatment for MS. Expand
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