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Statements

Subject Item
n2:RIV%2F00843989%3A_____%2F08%3A00103085%21RIV13-MZ0-00843989
rdf:type
n6:Vysledek skos:Concept
dcterms:description
Background A 24-week phase II trial has shown that 0 . 3 mg of laquinimod given daily to patients with relapsing-remitting multiple sclerosis was well tolerated and reduced the formation of active lesions. We assessed the effect of oral daily 0 . 3 and 0 . 6 mg laquinimod on MRI-monitored disease activity in a 36-week double-blind, placebo-controlled phase IIb study. Methods The study was done in 51 centres in nine countries. Inclusion criteria were one or more relapses in the year before entry and at least one gadolinium enhancing (GdE) lesion on screening MRI. Of 720 patients screened, 306 eligible patients were enrolled. Patients, aged 18-50 years, were randomly assigned to placebo (n=102), laquinimod 0 . 3 mg a day (n=98), or 0 . 6 mg a day (n=106). Brain MRI scans and clinical assessments were done at week -4, baseline, and monthly from week 12 to week 36. The primary outcome was the cumulative number of GdE lesions at weeks 24, 28, 32, and 36. The principal analysis of the primary endpoint was done on the intention-to-treat cohort. This study is registered with ClinicalTrials.gov, number NCT00349193. Findings Compared with placebo, treatment with laquinimod 0 . 6 mg per day showed a 40.4% reduction of the baseline adjusted mean cumulative number of GdE lesions per scan on the last four scans (simple means 4 - 2 [SD 9.2] vs 2.6 [5-3], p=0 . 0048); treatment with 0 . 3 mg per day showed no significant effects (3-9 [5.5] vs placebo, p=0.6740). Both doses of laquinimod were well tolerated, with some transient and dose-dependent increases in liver enzymes. A case of Budd-Chiari syndrome-ie, a thrombotic venous outflow obstruction of the liver-occurred after 1 month of exposure in a patient with underlying hypercoagulability who received 0.6 mg laquinimod. Anticoagulant treatment resulted in a decline of liver enzymes to normal without any clinical signs of hepatic decompensation. Interpretation In patients with relapsing-remitting multiple sclerosis, 0.6 mg per ... Background A 24-week phase II trial has shown that 0 . 3 mg of laquinimod given daily to patients with relapsing-remitting multiple sclerosis was well tolerated and reduced the formation of active lesions. We assessed the effect of oral daily 0 . 3 and 0 . 6 mg laquinimod on MRI-monitored disease activity in a 36-week double-blind, placebo-controlled phase IIb study. Methods The study was done in 51 centres in nine countries. Inclusion criteria were one or more relapses in the year before entry and at least one gadolinium enhancing (GdE) lesion on screening MRI. Of 720 patients screened, 306 eligible patients were enrolled. Patients, aged 18-50 years, were randomly assigned to placebo (n=102), laquinimod 0 . 3 mg a day (n=98), or 0 . 6 mg a day (n=106). Brain MRI scans and clinical assessments were done at week -4, baseline, and monthly from week 12 to week 36. The primary outcome was the cumulative number of GdE lesions at weeks 24, 28, 32, and 36. The principal analysis of the primary endpoint was done on the intention-to-treat cohort. This study is registered with ClinicalTrials.gov, number NCT00349193. Findings Compared with placebo, treatment with laquinimod 0 . 6 mg per day showed a 40.4% reduction of the baseline adjusted mean cumulative number of GdE lesions per scan on the last four scans (simple means 4 - 2 [SD 9.2] vs 2.6 [5-3], p=0 . 0048); treatment with 0 . 3 mg per day showed no significant effects (3-9 [5.5] vs placebo, p=0.6740). Both doses of laquinimod were well tolerated, with some transient and dose-dependent increases in liver enzymes. A case of Budd-Chiari syndrome-ie, a thrombotic venous outflow obstruction of the liver-occurred after 1 month of exposure in a patient with underlying hypercoagulability who received 0.6 mg laquinimod. Anticoagulant treatment resulted in a decline of liver enzymes to normal without any clinical signs of hepatic decompensation. Interpretation In patients with relapsing-remitting multiple sclerosis, 0.6 mg per ...
dcterms:title
Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study
skos:prefLabel
Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study
skos:notation
RIV/00843989:_____/08:00103085!RIV13-MZ0-00843989
n3:aktivita
n9:V n9:I n9:N
n3:aktivity
I, N, V
n3:cisloPeriodika
9630
n3:dodaniDat
n13:2013
n3:domaciTvurceVysledku
n8:8004420
n3:druhVysledku
n17:J
n3:duvernostUdaju
n7:S
n3:entitaPredkladatele
n14:predkladatel
n3:idSjednocenehoVysledku
365131
n3:idVysledku
RIV/00843989:_____/08:00103085
n3:jazykVysledku
n15:eng
n3:klicovaSlova
secondary progressive MS; Budd-Chiari syndrome; controlled trial; glatiramer acetate; hypointense lesions; interferon beta-1B; clinical trials; spin-echo; linomide; methylprednisolone
n3:klicoveSlovo
n4:secondary%20progressive%20MS n4:spin-echo n4:clinical%20trials n4:methylprednisolone n4:interferon%20beta-1B n4:hypointense%20lesions n4:glatiramer%20acetate n4:Budd-Chiari%20syndrome n4:controlled%20trial n4:linomide
n3:kodStatuVydavatele
GB - Spojené království Velké Británie a Severního Irska
n3:kontrolniKodProRIV
[79ACC60DFBE3]
n3:nazevZdroje
The lancet
n3:obor
n5:FH
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
95
n3:rokUplatneniVysledku
n13:2008
n3:svazekPeriodika
371
n3:tvurceVysledku
Sharrack, B. Zapletalová, Olga Pulizzi, A. Selmaj, K. W. Arbizu, T. Havrdová, E. Comi, G. Komoly, S. Gold, R. Abramsky, O. Boiko, A. Filippi, M. Rovaris, M.
n3:wos
000256932200028
s:issn
0140-6736
s:numberOfPages
8
n16:doi
10.1016/S0140-6736(08)60918-6