Date: 2012-01-26
Type of information: Initiation of the trial
phase: 3b
Announcement: initiation
Company: BiogenIdec (USA) Elan (Ireland)
Product: Tysabri® (natalizumab)
Action mechanism:
Disease: secondary-progressive multiple sclerosis (SPMS)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: 15 countries
Trial
details: 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.
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.
Tysabri® increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML.
Latest
news: Biogen Idec and Elan Corporation, have 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).
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. ASCEND is ongoing and actively enrolling patients.
