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The CombiRx trial of combined therapy with interferon and glatiramer acetate in relapsing remitting MS: Design and baseline characteristics
Journal article   Open access

The CombiRx trial of combined therapy with interferon and glatiramer acetate in relapsing remitting MS: Design and baseline characteristics

J.W. Lindsey, T.F. Scott, S.G. Lynch, S.S. Cofield, F. Nelson, R. Conwit, T. Gustafson, G.R. Cutter, J.S. Wolinsky, F.D. Lublin, …
Multiple sclerosis and related disorders, v 1(2), pp 81-86
Apr 2012
PMID: 25876935
url
https://europepmc.org/articles/pmc3384544View
Accepted (AM)Open Access (License Unspecified) Open

Abstract

Clinical trial Combination therapy Glatiramer acetate Interferon beta-1a Multiple sclerosis Randomized
Interferon-β1a (IFNB) and glatiramer acetate (GA) are distinct therapies which are both partially effective for relapsing MS. It is not known if combining the two treatments would be more effective. To review the rationale, design, and baseline characteristics of the CombiRx study of combined treatment with IFNB and GA. The key inclusion criteria included a diagnosis of relapsing MS, at least 2 episodes of MS activity in the previous 3 years, expanded disability status scale of 0–5.5, and no prior treatment with either IFNB or GA. Subjects were randomized to IFNB+GA, IFNB monotherapy, or GA monotherapy in a 2:1:1 ratio. From 2005 to 2009, we enrolled 1008 subjects. The participants were 72.4% female and 87.6% Caucasian with a mean age of 37.7 years. The median duration of symptoms was 2 years at entry into the study, and the mean EDSS was 2.1. On the baseline MRI, the mean total lesion load was 12.2ml, and 40% of the participants had enhancing lesions. We have recruited a population of patients with clinical and MRI characteristics typical for early MS. The study results will aid in deciding on the optimum early treatment. This trial should serve as a model for future studies of combination therapy. ► Available therapies for MS are only partially effective. ► Combining therapies might be more effective. ► We compared the combination of interferon and glatiramer to either agent alone. ► We present the baseline characteristics of our study population.

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Collaboration types
Domestic collaboration
Web of Science research areas
Clinical Neurology
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