Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (Tysabri^®) Dosing: NOVA Phase IIIb Extension Study (Part 2).

ABSTRACT:

Introduction

Following NOVA (part 1) and the approval of the subcutaneous (SC) route of administration of natalizumab by the European Medicines Agency, an extension phase of the NOVA phase IIIb study (part 2) was initiated to collect patient preference data for SC versus intravenous (IV) dosing in patients receiving every-6-week (Q6W) dosing of natalizumab. This study was performed to evaluate patient preference for SC versus IV natalizumab administration and explore the efficacy, safety, and pharmacology characteristics of both routes of administration.

Methods

In part 2, participants received natalizumab (Tysabri^®) 300 mg via IV infusion Q6W for 36 weeks and then were randomized to 48 weeks of crossover treatment (24 weeks SC Q6W and 24 weeks IV Q6W, or vice ver

SUBMITTER: Wiendl H 

PROVIDER: S-EPMC11393236 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature