This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Search for Related Content PubMed PubMed Citation Social Bookmarking                   What's this?

Double-blind randomized multicenter dose-comparison study of interferon-ß-1a (AVONEX): rationale, design and baseline data

We describe the rationale and design of a double-blind, randomized, multicenter, dose-comparison study of interferon-beta-1a (IFN-ß-1a; Avonex®), in the treatment of relapsing multiple sclerosis (MS). The study is expected to provide quantitative insights on the dose range for optimal clinical benefits in MS. The study involves 802 patients in 10 European countries who have EDSS scores 2.0-5.5, and who have experienced at least two relapses within the 3 years prior to enrolment. Patients are randomized to receive once-weekly intramuscular injections of IFN-ß-1a 30 or 60 mcg for at least 3 years. The primary endpoint of the study is the effect of IFN-ß-1a therapy on the time to sustained progression of disability. For patients with a baseline EDSS 44.5, sustained progression of disability is defined as a 1 point increase in EDSS from baseline, maintained for 6 months. For patients with baseline EDSS 55, sustained progression of disability is defined as reaching an EDSS 56.0, maintained for 6 months. EDSS scores will be determined every 3 months. A series of prospectively defined secondary and tertiary efficacy endpoints will be examined. Safety will be monitored throughout the study. Magnetic resonance imaging (MRI) with and without gadolinium-enhancement has been performed in at least 358 patients at baseline and repeated annually after enrolment. In a subset of these patients, a frequent MRI study is also being performed.

Key Words: interferon-ß-1 • multiple sclerosis • dose-comparison study design • MRI follow-up

Multiple Sclerosis, Vol. 7, No. 3, 179-183 (2001)
DOI: 10.1177/135245850100700308


CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				L. Kappos, M. Clanet, M. Sandberg-Wollheim, E. W. Radue, H. P. Hartung, R. Hohlfeld, J. Xu, D. Bennett, A. Sandrock, S. Goelz, et al. Neutralizing antibodies and efficacy of interferon {beta}-1a: A 4-year controlled study Neurology, July 12, 2005; 65(1): 40 - 47. [Abstract] [Full Text] [PDF]

				M Clanet, L Kappos, H-P Hartung, R Hohlfeld, and The European IFNss-1a Dose-Comparison Study Invest Interferon {beta}-1a in relapsing multiple sclerosis: four-year extension of the European IFN{beta}-1a Dose-C omparison Study Multiple Sclerosis, April 1, 2004; 10(2): 139 - 144. [Abstract] [PDF]

				M. Clanet, E.W. Radue, L. Kappos, H.P. Hartung, R. Hohlfeld, M. Sandberg-Wollheim, M.F. Kooijmans-Coutinho, E.C. Tsao, and A.W. Sandrock A randomized, double-blind, dose-comparison study of weekly interferon {beta}-1a in relapsing MS Neurology, November 26, 2002; 59(10): 1507 - 1517. [Abstract] [Full Text] [PDF]