Magnetization transfer ratio in the delayed-release dimethyl fumarate DEFINE study

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Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study

OBJECTIVE To evaluate the effects of oral delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on MRI lesion activity and load, atrophy, and magnetization transfer ratio (MTR) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (CONFIRM) study. METHODS CONFIRM was a 2-year, placebo-controlled study of the efficacy and safety of DM...

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Delayed-release dimethyl fumarate and disability assessed by the Multiple Sclerosis Functional Composite: Integrated analysis of DEFINE and CONFIRM

The effect of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the Multiple Sclerosis Functional Composite (MSFC) was assessed using integrated Phase 3 DEFINE and CONFIRM data. Patients treated with DMF (n = 769) demonstrated significant superiority on the MSFC, and each component, compared with placebo (n = 771) over two years: mean change for DMF vs placebo was 0...

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Consensus Management of Gastrointestinal Events Associated with Delayed-Release Dimethyl Fumarate: A Delphi Study.

INTRODUCTION Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF) is indicated for the treatment of patients with relapsing multiple sclerosis. Gastrointestinal (GI) adverse events (AEs) occur with DMF therapy. METHODS We used a Delphi process to reach consensus among North American clinicians on effective real-world management strategies for GI AEs associated with DMF....

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Time course of clinical and neuroradiological effects of delayed-release dimethyl fumarate in multiple sclerosis

BACKGROUND AND PURPOSE Delayed-release dimethyl fumarate (DMF, also known as gastro-resistant DMF), demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the 2-year, randomized, placebo-controlled, phase 3 DEFINE and CONFIRM trials. A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradi...

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BACKGROUND Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favorable benefit-risk profile for patients with relapsing-remitting multiple sclerosis (RRMS) in phase 3 DEFINE/CONFIRM studies. ENDORSE is an ongoing long-term extension of DEFINE/CONFIRM. OBJECTIVE We report efficacy and safety results of a 5-year interim analysis of ENDORSE (2 years DEFINE/CONFIRM; minim...

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ژورنال

عنوان ژورنال: Journal of Neurology

سال: 2014

ISSN: 0340-5354,1432-1459

DOI: 10.1007/s00415-014-7504-7