AIN457
Drug(10mg/kg i.v.).
Other names: AIN457 core/ AIN extension
NCT Number: NCT01433250
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 2
Novartis Investigative Site, Hradec Králové, Czech Republic, Czechia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
(10mg/kg i.v.).
Other names: AIN457 core/ AIN extension
Time frame: 97 weeks
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
Time frame: week 97
Description: number of relapses based on neurological assessments and EDSS
Time frame: weeks 13,25,37,53,73 and 97
Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans
Time frame: weeks 13,25,37,53,73 and 97
Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions
Time frame: week 97
Change in volume from start to end of study
Time frame: Baseline to week 97
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.
Novartis Pharmaceuticals
Industry
An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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