Journal article
Safety and immunogenicity of a new formulation of interferon beta-1a (Rebif (R) New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results
G Giovannoni, O Barbarash, F Casset-Semanaz, J King, L Metz, G Pardo, J Simsarian, PS Sorensen, B Stubinski
MULTIPLE SCLEROSIS JOURNAL | SAGE PUBLICATIONS LTD | Published : 2009
Abstract
BACKGROUND: A new formulation of subcutaneous (s.c.) interferon-beta-1a has been developed (Rebif New Formulation, RNF), produced without fetal bovine serum and without human serum albumin as an excipient, with the aim of improving injection tolerability, and reducing immunogenicity. OBJECTIVES: This article reports 96-week analyses of a Phase IIIb, open-label study of the safety and immunogenicity of RNF compared with historical (EVIDENCE study) and recent (REGARD study) data on the original formulation. METHODS: Patients with relapsing multiple sclerosis (McDonald criteria) and an Expanded Disability Status Scale score or=20 neutralizing units/mL) at week 96 (last observation carried forwa..
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Funding Acknowledgements
This study was sponsored by Merck Serono International S.A., Geneva, Switzerland (an affiliate of Merck KGaA, Darmstadt, Germany). The authors thank the many patients and site personnel and the RNF clinical trial team at Merck Serono International S. A., which included the following individuals: E. Abgrall, S. Brunati, P. Cornelisse, C. Filmer, S. Gerin, B. Granados, D. Issard, M. LopezBresnahan, P. Perrone, and J. Weiner. The authors also thank Matthew Evans, PhD (supported by Merck Serono International S. A., Geneva, Switzerland), for assistance with the preparation of the manuscript.