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)
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
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.
Details
Original language | English |
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Article number | 109 |
Journal | BMC neurology |
Volume | 16 |
Issue number | 1 |
Publication status | Published - 19 Jul 2016 |
Peer-reviewed | Yes |
External IDs
PubMed | 27430352 |
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Keywords
ASJC Scopus subject areas
Keywords
- Alemtuzumab, MSDS3D, Multiple sclerosis, Non-interventional trial, Real worl data, Risk-management plan