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)
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Published in |
BMC Neurology, July 2016
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DOI | 10.1186/s12883-016-0629-9 |
Pubmed ID | |
Authors |
Tjalf Ziemssen, Ulrich Engelmann, Sigbert Jahn, Alexandra Leptich, Raimar Kern, Lina Hassoun, Katja Thomas |
Abstract |
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. 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). 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. As non-interventional trial in Germany. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Germany | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 92 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 12 | 13% |
Student > Bachelor | 12 | 13% |
Student > Master | 11 | 12% |
Other | 10 | 11% |
Student > Ph. D. Student | 4 | 4% |
Other | 14 | 15% |
Unknown | 29 | 32% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 26 | 28% |
Psychology | 6 | 7% |
Nursing and Health Professions | 6 | 7% |
Neuroscience | 5 | 5% |
Business, Management and Accounting | 4 | 4% |
Other | 11 | 12% |
Unknown | 34 | 37% |