MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study.

ABSTRACT:

Objective

RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab.

Methods

Eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI. Patients were randomized 1:1:2 to continue natalizumab, to switch to placebo, or to receive alternative immunomodulatory therapy (other therapies: IM interferon β-1a [IM IFN-β-1a], glatiramer acetate [GA], or methylprednisolone [MP]). During the 24-week randomized treatment period, patients underwent clinical and MRI assessments every 4 weeks.

Results

Patients (n = 175) were randomized to natalizumab (n = 45), placebo (n = 42), or other therapies

SUBMITTER: Fox RJ 

PROVIDER: S-EPMC4011468 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature