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)
| Autor: | Raimar Kern, Ulrich Engelmann, Katja Thomas, Sigbert Jahn, Tjalf Ziemssen, Lina Hassoun, Alexandra Leptich |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
medicine.medical_specialty MSDS3D Neurology Active Comparator CD52 Non-interventional trial Clinical Neurology Antibodies Monoclonal Humanized Multiple sclerosis 03 medical and health sciences Study Protocol 0302 clinical medicine Cognition Multiple Sclerosis Relapsing-Remitting Quality of life Recurrence Germany medicine Humans 030212 general & internal medicine Prospective Studies Intensive care medicine Prospective cohort study Alemtuzumab Real worl data business.industry General Medicine medicine.disease Clinical trial Risk-management plan Physical therapy Quality of Life Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | BMC Neurology |
| ISSN: | 1471-2377 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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