The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Novartis Investigative Site
Hradec Králové, Czech Republic, Czechia
Novartis Investigative Site
Ostrava, Czechia
Novartis Investigative Site
Ostrava-Moravska Ostrava, Czechia
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Time frame: 97 weeks
Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)
Description: number of relapses based on neurological assessments and EDSS
Time frame: week 97
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI
Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T1-weighted scans
Time frame: weeks 13,25,37,53,73 and 97
Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI
Measures of absolute number of gadolinium \[Gd\]-enhancing lesions on T2-weighted lesions
Time frame: weeks 13,25,37,53,73 and 97
Change in Brain Volume at End of Study.
Change in volume from start to end of study
Time frame: week 97
Measure of Disability: Expanded Disability Status Scale (EDSS).
The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.
Time frame: Baseline to week 97
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Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Teplice, Czechia
Novartis Investigative Site
Kazan', Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Nizhny Novgorod, Russia
Novartis Investigative Site
Smolensk, Russia
Novartis Investigative Site
Kharkiv, Ukraine
...and 4 more locations