title: Rationale, design, and methods of a non-interventional study to establish safety, effectiveness, quality of life, cognition, health-related and work capacity data on Alemtuzumab in multiple sclerosis patients in Germany (TREAT-MS).
abstract: BACKGROUND
  Alemtuzumab, a humanized monoclonal antibody directed against the cell surface glycoprotein CD52, is licensed in Europe since October 2013 as treatment for adult patients with active relapsing-remitting multiple sclerosis (RRMS). In three randomized, rater-blinded active comparator clinical trials studies, alemtuzumab administered in two annual courses, had superior efficacy as compared to subcutaneous interferon beta-1a, and durable efficacy over 5 years in an extension study with a manageable safety profile in RRMS patients. Data on the utilization and the outcomes of alemtuzumab under clinical practice conditions are limited.
  
  
  METHODS
  Here we describe the rationale, design and methods of the TREAT-MS study (non-interventional long-Term study foR obsErvAtion of Treatment with alemtuzumab in active relapsing-remitting MS).
  
  
  CONCLUSIONS
  TREAT-MS is a prospective, multicenter, non-interventional, long-term study to collect data on safety, effectiveness, quality of life, cognition and other aspects from 3200 RRMS patients treated with alemtuzumab under the conditions of real-world clinical practice in Germany.
  
  
  BACKGROUND
  As non-interventional trial in Germany.
authors.affiliation: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany. Tjalf.Ziemssen@uniklinikum-dresden.de.
authors.forename: Tjalf
authors.identifier: http://orcid.org/0000-0001-8799-8202
authors.initials: T
authors.lastname: Ziemssen
authors.affiliation: Medical Affairs, Genzyme GmbH, Neu-Isenburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Engelmann
authors.affiliation: Medical Affairs, Genzyme GmbH, Neu-Isenburg, Germany.
authors.forename: Sigbert
authors.initials: S
authors.lastname: Jahn
authors.affiliation: Clinical Study Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Leptich
authors.affiliation: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
authors.forename: Raimar
authors.initials: R
authors.lastname: Kern
authors.affiliation: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
authors.forename: Lina
authors.initials: L
authors.lastname: Hassoun
authors.affiliation: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Thomas
mesh_terms: D000328:Adult; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D005858:Germany; D006801:Humans; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000074323:Alemtuzumab
keywords: Alemtuzumab; MSDS3D; Multiple sclerosis; Non-interventional trial; Real worl data; Risk-management plan