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Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies — ESCALATE  

Relapsing Multiple Sclerosis Clinical Trial

Official title:
A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02241785
Study type Interventional
Source Biogen
Contact
Status Terminated
Phase Phase 4
Start date September 2014
Completion date May 2016
View Details
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