NCT02241785

Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies

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)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	natalizumab	Administered as specified in the treatment arm

Timeline

• Start date: 2014-09-30
• Primary completion: 2016-05-02
• Completion: 2016-05-02
• First posted: 2014-09-16
• Last updated: 2017-06-05
• Results posted: 2017-06-05

Locations

11 sites across 1 country: United States