Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies
Status:
Terminated
Trial end date:
2016-05-02
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to determine the efficacy of natalizumab (Tysabri,
BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed
Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the
proportion of participants with no evidence of disease activity (NEDA) at Year 1. The
secondary objectives in this study population are: change in total T1 hypointense and total
T2 hyperintense lesion volume; proportion of participants with NEDA at Year 2; evaluation of
the impact of natalizumab on annualized relapse rate (ARR); and change in Multiple Sclerosis
Impact Scale-29 (MSIS-29) physical impact score.