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Avonex Combination Trial in relapsing—remitting MS: rationale, design and baseline dataMellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA, cohenj{at}ccf.org
Department of Neurology, Johns Hopkins, Baltimore, MD 21287, USA
Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
MS Center of Southern Vermont, Bennington, VT 05201, USA
Medical Affairs, Biogen Idec, Inc., Cambridge, MA 02142, USA
Department of Neurology, Virginia Commonwealth University Medical Center, Richmond, VA 23298, USA
Biomedical Engineering, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Mellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Department of Neurology, University of Rochester, Rochester, NY 14642, USA
Mellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Department of Neurology, Baylor College of Medicine, Houston, TX 77030, USA
Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Mellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Department of Rheumatic and Immunologic Disease, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Mellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Drexel College of Medicine, Pittsburgh, PA 15212, USA
Mellen Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
Medical Affairs, Biogen Idec, Inc., Cambridge, MA 02142, USA 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 IFNβ-1a) combined with methotrexate (MTX) and/or IV methylprednisolone (IVMP) in relapsing—remitting multiple sclerosis (RRMS) patients with continued disease activity on IM IFNβ-1a monotherapy.
Methods Eligibility criteria included RRMS, Expanded Disability Status Scale score 0—5.5, and 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-IFNβ 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. Multiple Sclerosis 2008; 14: 370—382. http://msj.sagepub.com
Key Words: clinical trial • interferon beta-1a • methotrexate • methylprednisolone • multiple sclerosis
This version was published on April
1, 2008 Multiple Sclerosis, Vol. 14, No. 3,
370-382 (2008) This article has been cited by other articles:
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1 relapse or gadolinium-enhancing MRI lesion in the prior year while on IM IFNβ-1a monotherapy. Subjects continued IFNβ-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. 
