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Prof Robert Zivadinov: Interferon Beta Study PROTRACT
PROTRACT is a multicentre retrospective real-world-evidence study ongoing in the United States and Canada. It is designed to show safety, efficacy and tolerability of FDA-approved modifying therapies on MS patients. Prof Zivadinov stated that this is the first real-world-evidence study to evaluate MRI data collected in 40 centers at one assessment center. The primary study objectives are to show the proportion of patients with no evidence of disease activity as defined by number of new relapses and appearance of T2 and gadolinium-enhancing lesions. Also included in the safety assessment is discontinuation due to adverse events or tolerability issues.
Prof Zivadinov discusses the strict inclusion criteria, and highlights that the investigators are identifying study subjects in the clinic and sending the clinical MRI data to the main assessment center; the advantage is that it is quicker than recruiting for a clinical trial over several years. About 1200 patients will be recruited from the 40 sites and divided into two groups; those remaining on a therapy for at least a year, and those for under one year.
The goal is to contribute to knowledge in the field on how oral versus injectable therapy is tolerated and how adverse events are influencing those patients with no evidence of disease activity. The investigators anticipate completing the study by mid-2017.
Professor Robert Zivadinov, Buffalo Neuroimaging Analysis Center, Jacobs Neurological Institute, State University of NY, Buffalo
This video was recorded at ECTRIMS 2016, September 14-17 2016, London, United Kingdom.