Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F12%3A11797" target="_blank" >RIV/00216208:11110/12:11797 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/12:11797 RIV/00064173:_____/12:N0000019
Result on the web
<a href="http://dx.doi.org/10.1056/NEJMoa1206328" target="_blank" >http://dx.doi.org/10.1056/NEJMoa1206328</a>
DOI - Digital Object Identifier
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Alternative languages
Result language
angličtina
Original language name
Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis
Original language description
In this phase 3, randomized study, we investigated the efficacy and safety of oral BG-12, at a dose of 240 mg two or three times daily, as compared with placebo in patients with relapsing-remitting multiple sclerosis. An active agent, glatiramer acetate,was also included as a reference comparator. The primary end point was the annualized relapse rate over a period of 2 years. The study was not designed to test the superiority or noninferiority of BG-12 versus glatiramer acetate. RESULTS At 2 years, theannualized relapse rate was significantly lower with twice-daily BG-12 (0.22), thrice-daily BG-12 (0.20), and glatiramer acetate (0.29) than with placebo (0.40) (relative reductions: twice-daily BG-12, 44%, P<0.001; thrice-daily BG-12, 51%, P<0.001; glatiramer acetate, 29%, P = 0.01). Reductions in disability progression with twice-daily BG-12, thrice-daily BG-12, and glatiramer acetate versus placebo (21%, 24%, and 7%, respectively) were not significant. As compared with placebo, twice
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FH - Neurology, neuro-surgery, nuero-sciences
OECD FORD branch
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Result continuities
Project
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Continuities
Z - Vyzkumny zamer (s odkazem do CEZ)
Others
Publication year
2012
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
New England Journal of Medicine
ISSN
0028-4793
e-ISSN
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Volume of the periodical
367
Issue of the periodical within the volume
12
Country of publishing house
US - UNITED STATES
Number of pages
11
Pages from-to
1087-1097
UT code for WoS article
000308861800004
EID of the result in the Scopus database
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