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)

BMC Neurol. 2016 Jul 19:16:109. doi: 10.1186/s12883-016-0629-9.

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).

Discussion: 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.

Trial registration: As non-interventional trial in Germany.

Keywords: Alemtuzumab; MSDS3D; Multiple sclerosis; Non-interventional trial; Real worl data; Risk-management plan.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alemtuzumab
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Cognition / drug effects
  • Germany
  • Humans
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Prospective Studies
  • Quality of Life*
  • Recurrence

Substances

  • Antibodies, Monoclonal, Humanized
  • Alemtuzumab