ASCEND Study to Evaluate the Effectiveness of TYSABRI® (natalizumab) as a Treatment for Secondary-Progressive Multiple Sclerosis
Press Release: Elan Corporation, plc – Thu, Jan 26, 2012 8:00 AM EST
WESTON, Mass. & DUBLIN--(BUSINESS WIRE)-- Biogen Idec... and Elan Corporation ... today announced a global Phase 3b study, ASCEND, that is being conducted to evaluate the effectiveness of TYSABRI as a treatment for secondary-progressive multiple sclerosis (SPMS). According to the National Multiple Sclerosis Society, approximately half of all people initially diagnosed with relapsing-remitting multiple sclerosis (RRMS) - the most common form of multiple sclerosis (MS) - will transition to SPMS within 19 years.
Patients with RRMS typically experience unpredictable relapses; the time between relapses is characterized by full or partial recovery and a lack of disease progression. SPMS is characterized by a steady progression of nerve damage, symptoms and disability, but the exact reasons for the progression are unknown. The potential for greater disease burden in SPMS typically includes decreased mobility, impaired activities of daily living, loss of independence and reduced quality of life.
"There are limited treatment options available to people living with SPMS and there is a high unmet need for effective therapies,” said Aaron Miller, M.D., member of the ASCEND advisory board; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis; and Co-Director of the Multiple Sclerosis Care Center at Maimonides Medical Center in Brooklyn, New York. “The ASCEND trial is investigating whether treatment with TYSABRI may prevent worsening in walking, hand movement and daily functioning in these patients.”
"One hypothesis behind the development of SPMS is that disease progression is a result of chronic inflammation in the brain tissue trapped behind the blood-brain-barrier. This causes destruction of the myelin sheath which protects the coating around nerve fibers, as well as the progressive loss of nerve cells, which can lead to disability in MS patients,” said Professor Richard Reynolds, Professor of Cellular Neuroscience, Imperial College, London; and Scientific Director of the UK Multiple Sclerosis Society Tissue Bank. “Preliminary data suggest that TYSABRI may hinder this inflammation in the brain and reduce SPMS-related disease progression; therefore, further investigation of this hypothesis is warranted."
The ASCEND study is part of the ongoing commitment of both Biogen Idec and Elan to find ways to improve the well-being of patients with multiple sclerosis.
About the ASCEND Study
ASCEND (A Study to Characterize the Efficacy of Natalizumab on Disability in SPMS) is a double-blind, placebo-controlled study with SPMS patients being randomized to receive either TYSABRI 300 mg or placebo intravenously every four weeks for 96 weeks. A global study, ASCEND is expected to enroll approximately 850 patients in 15 countries.
Study participants will be between the ages of 18 and 58, inclusive, with a diagnosis of SPMS for at least two years; an Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5, inclusive; MS Severity Score of 4 or higher; documented, confirmed evidence of disease progression, independent of clinical relapses during the one-year prior to enrollment; and naïve to TYSABRI treatment.
The primary endpoint is to investigate whether treatment with TYSABRI slows the accumulation of disability not related to relapses in subjects with SPMS.
Secondary endpoints are:
Press Release: Elan Corporation, plc – Thu, Jan 26, 2012 8:00 AM EST
WESTON, Mass. & DUBLIN--(BUSINESS WIRE)-- Biogen Idec... and Elan Corporation ... today announced a global Phase 3b study, ASCEND, that is being conducted to evaluate the effectiveness of TYSABRI as a treatment for secondary-progressive multiple sclerosis (SPMS). According to the National Multiple Sclerosis Society, approximately half of all people initially diagnosed with relapsing-remitting multiple sclerosis (RRMS) - the most common form of multiple sclerosis (MS) - will transition to SPMS within 19 years.
Patients with RRMS typically experience unpredictable relapses; the time between relapses is characterized by full or partial recovery and a lack of disease progression. SPMS is characterized by a steady progression of nerve damage, symptoms and disability, but the exact reasons for the progression are unknown. The potential for greater disease burden in SPMS typically includes decreased mobility, impaired activities of daily living, loss of independence and reduced quality of life.
"There are limited treatment options available to people living with SPMS and there is a high unmet need for effective therapies,” said Aaron Miller, M.D., member of the ASCEND advisory board; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis; and Co-Director of the Multiple Sclerosis Care Center at Maimonides Medical Center in Brooklyn, New York. “The ASCEND trial is investigating whether treatment with TYSABRI may prevent worsening in walking, hand movement and daily functioning in these patients.”
"One hypothesis behind the development of SPMS is that disease progression is a result of chronic inflammation in the brain tissue trapped behind the blood-brain-barrier. This causes destruction of the myelin sheath which protects the coating around nerve fibers, as well as the progressive loss of nerve cells, which can lead to disability in MS patients,” said Professor Richard Reynolds, Professor of Cellular Neuroscience, Imperial College, London; and Scientific Director of the UK Multiple Sclerosis Society Tissue Bank. “Preliminary data suggest that TYSABRI may hinder this inflammation in the brain and reduce SPMS-related disease progression; therefore, further investigation of this hypothesis is warranted."
The ASCEND study is part of the ongoing commitment of both Biogen Idec and Elan to find ways to improve the well-being of patients with multiple sclerosis.
About the ASCEND Study
ASCEND (A Study to Characterize the Efficacy of Natalizumab on Disability in SPMS) is a double-blind, placebo-controlled study with SPMS patients being randomized to receive either TYSABRI 300 mg or placebo intravenously every four weeks for 96 weeks. A global study, ASCEND is expected to enroll approximately 850 patients in 15 countries.
Study participants will be between the ages of 18 and 58, inclusive, with a diagnosis of SPMS for at least two years; an Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5, inclusive; MS Severity Score of 4 or higher; documented, confirmed evidence of disease progression, independent of clinical relapses during the one-year prior to enrollment; and naïve to TYSABRI treatment.
The primary endpoint is to investigate whether treatment with TYSABRI slows the accumulation of disability not related to relapses in subjects with SPMS.
Secondary endpoints are:
- The proportion of subjects with consistent improvement in Timed 25-foot Walk (T25FW);
- The change in subject-reported ambulatory status as measured by the 12-Item MS Walking Scale (MSWS-12);
- The change in manual ability based on the ABILHAND questionnaire;
- The impact of TYSABRI on subject-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical);
- The change in whole brain volume between the end of study and week 24 using MRI; and
- The proportion of subjects experiencing progression of disability as measured by individual physical EDSS system scores.
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