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Avonex Combination Trial in relapsing-remitting MS: rationale, design and baseline data
Journal article   Peer reviewed

Avonex Combination Trial in relapsing-remitting MS: rationale, design and baseline data

J. A. Cohen, P. A. Calabresi, S. Chakraborty, K. R. Edwards, T. Eickenhorst, W. L. Felton, E. Fisher, R. J. Fox, A. D. Goodman, C. Hara-Cleaver, …
Multiple sclerosis, v 14(3), pp 370-382
01 Apr 2008
DOI: https://doi.org/10.1177/1352458507083189
PMID: 18208877
Featured in Collection :   UN Sustainable Development Goals @ Drexel

Abstract

Clinical Neurology Life Sciences & Biomedicine Neurosciences Neurosciences & Neurology Science & Technology
Objective To review the rationale, design and baseline data of the Avonex Combination Trial (ACT), an investigator-run study of intramuscular interferon beta-1a (IM IFN beta-1a) combined with methotrexate (MTX) and/or IV methylprednisolone (IVMP) in relapsing-remitting multiple sclerosis (RRMS) patients with continued disease activity on IM IFN beta-1a monotherapy. Methods Eligibility criteria included RRMS, Expanded Disability Status Scale score 0-5.5, and >= 1 relapse or gadolinium-enhancing MRI lesion in the prior year while on IM IFN beta-1a monotherapy. Subjects continued IFN beta-1a 30 mcg IM weekly and were randomized in a 2 x 2 factorial design to adjunctive weekly placebo or MTX 20 mg PO, with or without IVMP 1000 mg/day for three days every other month. ACT was industry-supported, and collaboratively designed and governed by an Investigator Steering Committee with independent Advisory and Data Safety Monitoring Committees. Study operations, MRI analysis and aggregated data were managed by the Cleveland Clinic MS Academic Coordinating Center. Results In total 313 subjects were enrolled with clinical and MRI characteristics typical of RRMS. Most subjects (86.9%) qualified with a clinical relapse, with or without an enhancing MRI lesion, in the preceding year. At baseline, 21.4% had enhancing lesions, and 5.1% had anti-IFN beta neutralizing antibodies. ACT's management and operational structures functioned well. Conclusion This study provides an innovative model for academic-industry collaborative MS research and will enhance understanding of the utility of combination therapy for RRMS patients with continued disease activity on an established first-line treatment.

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Collaboration types
Industry collaboration
Domestic collaboration
Web of Science research areas
Clinical Neurology
Neurosciences
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