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Clinical Trial Summary

The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.


Clinical Trial Description

iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period. ;


Study Design


Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing-Remitting Multiple Sclerosis

NCT number NCT01943526
Study type Observational
Source Biogen
Contact
Status Completed
Phase
Start date November 30, 2011
Completion date December 31, 2017

See also
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