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Lillian Pardo - One of the best experts on this subject based on the ideXlab platform.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:OBJECTIVE: To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. METHODS: A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0-5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5-6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. RESULTS: There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71-1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53-0.95]; p = 0.0193). INTERPRETATION: The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:Objective To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. Methods A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0–5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5–6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. Results There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71–1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53–0.95]; p = 0.0193). Interpretation The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated. Ann Neurol 2007;61:14–24
Kenneth P Johnson - One of the best experts on this subject based on the ideXlab platform.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:OBJECTIVE: To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. METHODS: A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0-5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5-6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. RESULTS: There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71-1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53-0.95]; p = 0.0193). INTERPRETATION: The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:Objective To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. Methods A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0–5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5–6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. Results There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71–1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53–0.95]; p = 0.0193). Interpretation The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated. Ann Neurol 2007;61:14–24
Aaron Miller - One of the best experts on this subject based on the ideXlab platform.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:OBJECTIVE: To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. METHODS: A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0-5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5-6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. RESULTS: There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71-1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53-0.95]; p = 0.0193). INTERPRETATION: The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:Objective To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. Methods A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0–5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5–6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. Results There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71–1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53–0.95]; p = 0.0193). Interpretation The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated. Ann Neurol 2007;61:14–24
Jerry S Wolinsky - One of the best experts on this subject based on the ideXlab platform.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:OBJECTIVE: To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. METHODS: A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0-5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5-6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. RESULTS: There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71-1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53-0.95]; p = 0.0193). INTERPRETATION: The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated.
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glatiramer acetate in primary progressive multiple sclerosis results of a multinational multicenter double blind placebo controlled trial
Annals of Neurology, 2007Co-Authors: Jerry S Wolinsky, Ponnada A Narayana, Paul Oconnor, P K Coyle, Corey C Ford, Kenneth P Johnson, Aaron Miller, Lillian PardoAbstract:Objective To determine whether glatiramer acetate (GA) slows accumulation of Disability in primary progressive multiple sclerosis. Methods A total of 943 patients with primary progressive multiple sclerosis were randomized to GA or placebo (PBO) in this 3-year, double-blind trial. The primary end point was an intention-to-treat analysis of time to 1- (entry expanded Disability Status scale, 3.0–5.0) or 0.5-point expanded Disability Status scale change (entry expanded Disability Status scale, 5.5–6.5) sustained for 3 months. The trial was stopped after an interim analysis by an independent data safety monitoring board indicated no discernible treatment effect on the primary outcome. Intention-to-treat analyses of Disability and magnetic resonance imaging end points were performed. Results There was a nonsignificant delay in time to sustained accumulated Disability in GA- versus PBO-treated patients (hazard ratio, 0.87 [95% confidence interval, 0.71–1.07]; p = 0.1753), with significant decreases in enhancing lesions in year 1 and smaller increases in T2 lesion volumes in years 2 and 3 versus PBO. Post hoc analysis showed that survival curves for GA-treated male patients diverged early from PBO-treated male subjects (hazard ratio, 0.71 [95% confidence interval, 0.53–0.95]; p = 0.0193). Interpretation The trial failed to demonstrate a treatment effect of GA on primary progressive multiple sclerosis. Both the unanticipated low event rate and premature discontinuation of study medication decreased the power to detect a treatment effect. Post hoc analysis suggests GA may have slowed clinical progression in male patients who showed more rapid progression when untreated. Ann Neurol 2007;61:14–24
Tom Broekmans - One of the best experts on this subject based on the ideXlab platform.
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the relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis
Multiple Sclerosis Journal, 2013Co-Authors: Tom Broekmans, Geert Alders, Domien Gijbels, Ilse Lamers, Bert O. Eijnde, Machteld RoelantsAbstract:Background:In persons with multiple sclerosis (PwMS) resistance training improves muscle strength but effects on walking capacity are inconsistent.Objective:The objective was to determine the relation between different types of upper leg muscle strength measurements and walking capacity in PwMS.Methods:An observational cross-sectional study design was applied. Upper leg muscle strength of 52 PwMS (Expanded Disability Status Scale, EDSS range 1.5–6.5) was measured using isometric (knee extensors and flexors) and isokinetic (knee extensors) dynamometry. Walking capacity was assessed using the Timed 25-Foot Walk, Timed Up and Go and Two Minute Walk Test. Subgroups with mild (EDSS 1.5–4.0, n=31) and moderate (EDSS 4.5–6.5, n=21) ambulatory dysfunction were distinguished, and results were hypothesized to differ depending on multiple sclerosis (MS)-related Disability Status. Correlation and regression analyses were performed on the data of the most affected leg.Results:Greatest (r: 0.2–0.7) and significant Pear...
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the relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis
Multiple Sclerosis Journal, 2013Co-Authors: Tom Broekmans, Geert Alders, Domien Gijbels, Ilse Lamers, Bert O. Eijnde, Machteld RoelantsAbstract:Background:In persons with multiple sclerosis (PwMS) resistance training improves muscle strength but effects on walking capacity are inconsistent.Objective:The objective was to determine the relation between different types of upper leg muscle strength measurements and walking capacity in PwMS.Methods:An observational cross-sectional study design was applied. Upper leg muscle strength of 52 PwMS (Expanded Disability Status Scale, EDSS range 1.5–6.5) was measured using isometric (knee extensors and flexors) and isokinetic (knee extensors) dynamometry. Walking capacity was assessed using the Timed 25-Foot Walk, Timed Up and Go and Two Minute Walk Test. Subgroups with mild (EDSS 1.5–4.0, n=31) and moderate (EDSS 4.5–6.5, n=21) ambulatory dysfunction were distinguished, and results were hypothesized to differ depending on multiple sclerosis (MS)-related Disability Status. Correlation and regression analyses were performed on the data of the most affected leg.Results:Greatest (r: 0.2–0.7) and significant Pear...