Ireland Natalizumab (TYSABRI) Observational Program
Ireland Natalizumab (TYSABRI) Observational Program
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.
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.
Key Inclusion Criteria:

 -  Must give written informed consent and assent, as applicable.

 -  Decision to treat with natalizumab must precede enrollment.

 -  Patient characteristics and contraindications to treatment with natalizumab in
 accordance with prescribing information.

 -  Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with
 the natalizumab indication statement.

 -  Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.