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Statements

Subject Item
n2:RIV%2F00843989%3A_____%2F08%3A00103127%21RIV13-MZ0-00843989
rdf:type
n11:Vysledek skos:Concept
dcterms:description
To evaluate the efficacy and safety of BHT-3009 in relapsing-remitting multiple sclerosis (MS) and to confirm that BHT-3009 causes immune tolerance. BHT-3009 is a tolerizing DNA vaccine for MS, encoding full-length human myelin basic protein. Relapsing-remitting MS patients were randomized 1:1:1 into three groups: placebo, 0.5 mg BHT-3009, or 1.5 mg BHT-3009, given intramuscularly at weeks 0, 2, 4, and every 4 weeks thereafter until week 44. The primary end point was the 4-week rate of occurrence of new gadolinium-enhancing lesions on brain magnetic resonance images from weeks 28 to 48. Protein microarrays were used to measure levels of anti-myelin autoantibodies. RESULTS: Compared with placebo, in the 267 patient analysis population the median 4-week rate of new enhancing lesions during weeks 28 to 48 was 50% lower with 0.5 mg BHT-3009 (p = 0.07) and during weeks 8 to 48 was 61% lower with 0.5 mg BHT-3009 (p = 0.05). The mean volume of enhancing lesions at week 48 was 51% lower on 0.5 mg BHT-3009 compared with placebo (p = 0.02). No significant improvement in magnetic resonance imaging lesion parameters was observed with 1.5 mg BHT-3009. Dramatic reductions in 23 myelin-specific autoantibodies in the 0.5 mg BHT-3009 arm were observed, but not with placebo or 1.5 mg BHT-3009. CONCLUSIONS: In relapsing-remitting MS patients, treatment with the lower dose (0.5 mg) of BHT-3009 for 44 weeks nearly attained the primary end point for reduction of the rate of new enhancing magnetic resonance imaging lesions (p = 0.07) and achieved several secondary end points including a reduction of the rate of enhancing magnetic resonance imaging lesions from weeks 8 to 48 (p = 0.05). Immunological data in a preselected subgroup of patients also indicated that treatment with 0.5 mg induced antigen-specific immune tolerance. The greater dose was ineffective. To evaluate the efficacy and safety of BHT-3009 in relapsing-remitting multiple sclerosis (MS) and to confirm that BHT-3009 causes immune tolerance. BHT-3009 is a tolerizing DNA vaccine for MS, encoding full-length human myelin basic protein. Relapsing-remitting MS patients were randomized 1:1:1 into three groups: placebo, 0.5 mg BHT-3009, or 1.5 mg BHT-3009, given intramuscularly at weeks 0, 2, 4, and every 4 weeks thereafter until week 44. The primary end point was the 4-week rate of occurrence of new gadolinium-enhancing lesions on brain magnetic resonance images from weeks 28 to 48. Protein microarrays were used to measure levels of anti-myelin autoantibodies. RESULTS: Compared with placebo, in the 267 patient analysis population the median 4-week rate of new enhancing lesions during weeks 28 to 48 was 50% lower with 0.5 mg BHT-3009 (p = 0.07) and during weeks 8 to 48 was 61% lower with 0.5 mg BHT-3009 (p = 0.05). The mean volume of enhancing lesions at week 48 was 51% lower on 0.5 mg BHT-3009 compared with placebo (p = 0.02). No significant improvement in magnetic resonance imaging lesion parameters was observed with 1.5 mg BHT-3009. Dramatic reductions in 23 myelin-specific autoantibodies in the 0.5 mg BHT-3009 arm were observed, but not with placebo or 1.5 mg BHT-3009. CONCLUSIONS: In relapsing-remitting MS patients, treatment with the lower dose (0.5 mg) of BHT-3009 for 44 weeks nearly attained the primary end point for reduction of the rate of new enhancing magnetic resonance imaging lesions (p = 0.07) and achieved several secondary end points including a reduction of the rate of enhancing magnetic resonance imaging lesions from weeks 8 to 48 (p = 0.05). Immunological data in a preselected subgroup of patients also indicated that treatment with 0.5 mg induced antigen-specific immune tolerance. The greater dose was ineffective.
dcterms:title
Phase 2 trial of a DNA vaccine encoding myelin basic protein for multiple sclerosis. Phase 2 trial of a DNA vaccine encoding myelin basic protein for multiple sclerosis.
skos:prefLabel
Phase 2 trial of a DNA vaccine encoding myelin basic protein for multiple sclerosis. Phase 2 trial of a DNA vaccine encoding myelin basic protein for multiple sclerosis.
skos:notation
RIV/00843989:_____/08:00103127!RIV13-MZ0-00843989
n3:aktivita
n12:V n12:N
n3:aktivity
N, V
n3:cisloPeriodika
5
n3:dodaniDat
n6:2013
n3:domaciTvurceVysledku
n14:7634536
n3:druhVysledku
n15:J
n3:duvernostUdaju
n9:S
n3:entitaPredkladatele
n8:predkladatel
n3:idSjednocenehoVysledku
386476
n3:idVysledku
RIV/00843989:_____/08:00103127
n3:jazykVysledku
n17:eng
n3:klicovaSlova
altered peptide ligand; autoimmune encephalomyelitis; diagnostic criteria; induction; tolerance; immunity
n3:klicoveSlovo
n5:autoimmune%20encephalomyelitis n5:diagnostic%20criteria n5:immunity n5:altered%20peptide%20ligand n5:tolerance n5:induction
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[FEAA62F4BA6A]
n3:nazevZdroje
Annals of neurology
n3:obor
n16:FH
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
54
n3:rokUplatneniVysledku
n6:2008
n3:svazekPeriodika
63
n3:tvurceVysledku
Utz, P. J. Garren, H. Doležil, David Nadj, C. Valone, F. Kidd, B. A. Robinson, W. H. Nadj, I. Losy, J. Gianettoni, J. Selmaj, K. W. Havrdová, E. Krasulová, E. Steinman, L. Radue, E. W. Tersini, K.
n3:wos
000255960600010
s:issn
0364-5134
s:numberOfPages
10
n13:doi
10.1002/ana.21370