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| Description
| - METHODS We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. The primary end point was the proportion of patients who had a relapse by 2 years. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI. RESULTS The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. 46% with placebo, P<0.001 for both comparisons). The annualized relapse rate at 2 years was 0.17 in the twice-daily BG-12 group and 0.19 in the thrice-daily BG-12 group, as compared with 0.36 in the placebo group, representing relative reductions of 53% and 48% with the two BG-12 regimens, respectively (P<0.001 for the comparison of each BG-12 regimen with placebo). The estimated proportion of patients with confirmed progression of disability was 16% in the twice-daily BG-12 group, 18% in the thrice-daily BG-12 group, and 27% in the placebo group, with significant relative risk reductions of 38% with BG-12 twice daily (P = 0.005) and 34% with BG-12 thrice daily (P = 0.01). BG-12 also significantly reduced the number of gadolinium-enhancing lesions and of new or enlarging T-2-weighted hyperintense lesions (P<0.001 for the comparison of each BG-12 regimen with placebo). Adverse events associated with BG-12 included flushing and gastrointestinal events, such as diarrhea, nausea, and upper abdominal pain, as well as decreased lymphocyte counts and elevated liver aminotransferase levels.
- METHODS We conducted a randomized, double-blind, placebo-controlled phase 3 study involving patients with relapsing-remitting multiple sclerosis. Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. The primary end point was the proportion of patients who had a relapse by 2 years. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI. RESULTS The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. 46% with placebo, P<0.001 for both comparisons). The annualized relapse rate at 2 years was 0.17 in the twice-daily BG-12 group and 0.19 in the thrice-daily BG-12 group, as compared with 0.36 in the placebo group, representing relative reductions of 53% and 48% with the two BG-12 regimens, respectively (P<0.001 for the comparison of each BG-12 regimen with placebo). The estimated proportion of patients with confirmed progression of disability was 16% in the twice-daily BG-12 group, 18% in the thrice-daily BG-12 group, and 27% in the placebo group, with significant relative risk reductions of 38% with BG-12 twice daily (P = 0.005) and 34% with BG-12 thrice daily (P = 0.01). BG-12 also significantly reduced the number of gadolinium-enhancing lesions and of new or enlarging T-2-weighted hyperintense lesions (P<0.001 for the comparison of each BG-12 regimen with placebo). Adverse events associated with BG-12 included flushing and gastrointestinal events, such as diarrhea, nausea, and upper abdominal pain, as well as decreased lymphocyte counts and elevated liver aminotransferase levels. (en)
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| Title
| - Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis
- Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis (en)
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| skos:prefLabel
| - Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis
- Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis (en)
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| skos:notation
| - RIV/00064203:_____/12:8454!RIV13-MZ0-00064203
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| http://linked.open...avai/predkladatel
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| http://linked.open...avai/riv/aktivita
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| http://linked.open...avai/riv/aktivity
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| http://linked.open...iv/cisloPeriodika
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| http://linked.open...vai/riv/dodaniDat
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| http://linked.open...aciTvurceVysledku
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| http://linked.open.../riv/druhVysledku
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| http://linked.open...iv/duvernostUdaju
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| http://linked.open...titaPredkladatele
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| http://linked.open...dnocenehoVysledku
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| http://linked.open...ai/riv/idVysledku
| - RIV/00064203:_____/12:8454
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| http://linked.open...riv/jazykVysledku
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| http://linked.open.../riv/klicovaSlova
| - controlled trial; oxidative stress; cells; fingolimod; disability; pathway (en)
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| http://linked.open.../riv/klicoveSlovo
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| http://linked.open...odStatuVydavatele
| - US - Spojené státy americké
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| http://linked.open...ontrolniKodProRIV
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| http://linked.open...i/riv/nazevZdroje
| - New England Journal of Medicine
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| http://linked.open...in/vavai/riv/obor
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| http://linked.open...ichTvurcuVysledku
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| http://linked.open...cetTvurcuVysledku
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| http://linked.open...UplatneniVysledku
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| http://linked.open...v/svazekPeriodika
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| http://linked.open...iv/tvurceVysledku
| - Ambler, Z.
- Gold, R.
- Kappos, L.
- Novák, J.
- Yang, M.
- …
- Goldman, M.
- Rektor, I.
- Ware, J.
- Meluzínová, Eva
- Confavreux, C.
- Giovannoni, G.
- Polman, C.
- Barnett, M.
- Grammond, P.
- Lechner-Scott, J.
- Havrdova, E.
- Arnold, D.
- Vachová, M.
- Antel, J.
- Bakris, G.
- Bar-Or, A.
- Belachew, S.
- Beran, R.
- Berger, T.
- Bhan, V.
- Bouchart, J. P.
- Brandes, D.
- Brassat, D.
- Brinar, V.
- Butzkueven, H.
- Camu, W.
- Casse, R.
- Chapman, C.
- Christie, S.
- Chung, R.
- Clavelou, P.
- Cohen, B.
- Coman, AI
- Dawson, KT
- Decoo, D.
- Demarin, V.
- Deyn, PP
- Diem, R.
- Doležil, D.
- Dubois, B.
- Fazekas, F.
- Gallacher, P.
- Grgic, S.
- Herndon, R.
- Jacques, F.
- Kanovsky, P.
- Kowey, PR
- Macdonell, R.
- Medaer, R.
- Milla, C.
- Miller, A.
- Paine, M.
- Ransmayr, G.
- Richert, J.
- Rudež, J.
- Schwartz, R.
- Seeldrayers, P.
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