Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Keywords: TYSABRI naive Relapsing-remitting multiple sclerosis (RRMS)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 224
Healthy volunteers: no

Brief summary:
The primary objective of the study is to evaluate the evolution of walking capacity as measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of therapy with natalizumab. The secondary objectives of this study are as follows:

* To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.
* To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all participants and in the subgroups of participants stratified by baseline EDSS.

Detailed description:

Arms:
arm 1: natalizumab 300 mg IV every 4 weeks for 48 weeks

Interventions: intervention 1: BG00002 (natalizumab)
Intervention descriptions: intervention 1: None

Protocol document: