Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
730
Trial Sponsor
Clinical Trial Start Date
2012
0Primary Completion Date
2017
0Study Completion Date
2018
0Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Official Name
Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients0
Last Updated
January 12, 2016
0Study summary
The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.
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