Biogen Trial Transparency
Study Detail Header
/ / RUS-TYS-11-10158
Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
Study IdentifierRUS-TYS-11-10158
Clinicaltrials.gov
#NCT02142205
Details
Development Status
Approved
Study Type
Interventional
Results Available
Yes
Study Dates
05/2012 - 12/2013
Enrollment
100
Commercial Product
TYSABRI®
Study Drug
BG00002 (natalizumab)
Summary
The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002, Tysabri®) in the study population (Russian participants with relapsing remitting multiple sclerosis). The secondary objectives are to look at evaluation of severity of relapse, hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS), functional tests, quality of life self-assessment questionnaires including the short form health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29 (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.
Study Results
View and download the Results Summaries with the results of this completed study.
PDF
CSR Synopsis
PDF Document