Journal article
Results of the Avonex Combination Trial (ACT) in relapsing-remitting MS
Neurology, v 72(6), pp 535-541
10 Feb 2009
PMID: 19204263
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Abstract
Objective: To assess the safety, tolerability, and efficacy of interferon beta-1a (IFN beta-1a) combined with methotrexate (MTX), IV methylprednisolone (IVMP), or both in patients with relapsing-remitting multiple sclerosis (RRMS) with continued disease activity on 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 on IFN beta-1a monotherapy. Participants continued weekly IFN beta-1a 30 mu g IM and were randomized in a 2 x 2 factorial design to adjunctive weekly placebo or MTX 20 mg PO, with or without bimonthly IVMP 1,000 mg/day for 3 days. The primary endpoint was new or enlarged T2 lesion number at month 12 vs baseline. The study was industry-supported, collaboratively designed, and governed by an investigator Steering Committee with independent Advisory and Data Safety Monitoring committees. Study operations, MRI analyses, and aggregated data were managed by an academic coordinating center.
Results: The 313 participants had clinical and MRI characteristics typical of RRMS. Combinations of IFN beta-1a with MTX or IVMP were generally safe and well tolerated. Although trends suggesting modest benefit were seen for some outcomes for IVMP, the results did not demonstrate significant benefit for either adjunctive therapy. The data suggested IVMP reduced anti-IFN beta neutralizing antibody titers.
Conclusions: This trial did not demonstrate benefit of adding low-dose oral methotrexate or every other month IV methylprednisolone to interferon beta-1a in relapsing-remitting multiple sclerosis. Neurology (R) 2009; 72: 535-541
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Details
- Title
- Results of the Avonex Combination Trial (ACT) in relapsing-remitting MS
- Creators
- J. A. Cohen - MedicineP. B. Imrey - Mellen Center for Multiple SclerosisP. A. Calabresi - Johns Hopkins UniversityK. R. Edwards - Southern Vermont CollegeT. Eickenhorst - BiogenW. L. Felton - Virginia Commonwealth UniversityE. Fisher - Cleveland ClinicR. J. Fox - MedicineA. D. Goodman - University of RochesterC. Hara-Cleaver - Cleveland ClinicG. J. Hutton - Baylor College of MedicineB. F. Mandell - Rheumatologic & Immunologic DiseaseT. F. Scott - Drexel UniversityH. Zhang - Biogen (United States)C. Apperson-Hansen - Case Western Reserve UniversityG. J. Beck - Quantitative BioSciencesP. L. Houghtaling - Cleveland ClinicM. T. Karafa - Cleveland ClinicM. Stadtler - Cleveland ClinicACT Investigators
- Publication Details
- Neurology, v 72(6), pp 535-541
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 7
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Neurology
- Web of Science ID
- WOS:000263187000010
- Scopus ID
- 2-s2.0-62149143732
- Other Identifier
- 991019167534404721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Clinical Neurology