WAIT FOR SUGGESTIONS BY CATEGORY OR CONTINUE TYPING IN YOUR KEYWORDS
ENTER ONE OR MULTIPLE KEYWORDS & PRESS THE SEARCH BUTTON
Search
Favorites
Favorites
AdvancedMinimize
Clear
TREAT-MS: design and baseline characteristics of a noninterventional study to establish effectiveness, quality of life, cognition, health-related, and work capacity data on alemtuzumab in multiple sclerosis patients in Germany
Author(s):
T. Ziemssen
,
T. Ziemssen
Affiliations: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden
A. Leptich
,
A. Leptich
Affiliations: Clinical Study Unit, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main
S. Jahn
,
S. Jahn
Affiliations: Medical Affairs, Genzyme GmbH, Neu-Isenburg, Germany
R. Kern
,
R. Kern
Affiliations: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden
U. Engelmann
,
U. Engelmann
Affiliations: Medical Affairs, Genzyme GmbH, Neu-Isenburg, Germany
Background: Alemtuzumab, a humanised monoclonal antibody, is licensed in Germany since October 2013 as treatment for patients with active relapsing-remitting multiple sclerosis (RRMS). In 2-year phase 3 studies, alemtuzumab had superior efficacy as compared to subcutaneous interferon beta-1a and durable efficacy over 4 years in an extension study with manageable safety in RRMS patients.
Goals: To report on the study design and baseline characteristics of enrolled patients in TREAT-MS: a non-interventional long-Term study foR obsErvAtion of Treatment with LEMTRADA® in active RRMS.
Methods: This noninterventional effectiveness study is a prospective treatment with alemtuzumab in approximately 3000 RRMS patients from neurological clinics and practices. Planned recruitment is until end of 2016. The study comprises a 5-year observation period. The following instruments will be used: Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS), EuroQoL EQ-5D™, Work Productivity and Activity Impairment (WPAI), and Symbol Digit Modalities Test (SDMT). The Multiple Sclerosis Documentation System (MSDS) Project Development Group in Dresden adapted the patient-management software, MSDS3D, for use in this study. TREAT-MS will also fulfil a quality assurance function. Risk-management plan (RMP) measures such as monitoring for thyroid disorders, immune thrombocytopenia and nephropathies, and regular laboratory tests/urinalyses are represented in TREAT-MS and integrated into MSDS3D.
Results: Study enrolment began in October 2014 and 80 patients have been enrolled to date. First baseline characteristic data will be presented.
Conclusion: Implementation of RMP and perspective documentation of efficacy/safety data are combined in the TREAT-MS study.
Disclosure: Study supported by Genzyme, a Sanofi company.
TZ: Compensation for consulting services (Almirall, Bayer, Biogen Idec, Genzyme, GlaxoSmithKline, MSD, Merck Serono, Novartis, Sanofi, Synthon, and Teva); financial support for research activities (Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi, and Teva).
AL: Compensation as an employee (Sanofi Aventis).
SJ: Compensation as an employee (Genzyme).
RK: Compensation for consulting services (Teva, Bayer Healthcare, Genzyme, Biogen Idec, and Novartis).
UE: Compensation as an employee (Genzyme).
Abstract: P1145
Type: Poster
Abstract Category: Others
Background: Alemtuzumab, a humanised monoclonal antibody, is licensed in Germany since October 2013 as treatment for patients with active relapsing-remitting multiple sclerosis (RRMS). In 2-year phase 3 studies, alemtuzumab had superior efficacy as compared to subcutaneous interferon beta-1a and durable efficacy over 4 years in an extension study with manageable safety in RRMS patients.
Goals: To report on the study design and baseline characteristics of enrolled patients in TREAT-MS: a non-interventional long-Term study foR obsErvAtion of Treatment with LEMTRADA® in active RRMS.
Methods: This noninterventional effectiveness study is a prospective treatment with alemtuzumab in approximately 3000 RRMS patients from neurological clinics and practices. Planned recruitment is until end of 2016. The study comprises a 5-year observation period. The following instruments will be used: Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS), EuroQoL EQ-5D™, Work Productivity and Activity Impairment (WPAI), and Symbol Digit Modalities Test (SDMT). The Multiple Sclerosis Documentation System (MSDS) Project Development Group in Dresden adapted the patient-management software, MSDS3D, for use in this study. TREAT-MS will also fulfil a quality assurance function. Risk-management plan (RMP) measures such as monitoring for thyroid disorders, immune thrombocytopenia and nephropathies, and regular laboratory tests/urinalyses are represented in TREAT-MS and integrated into MSDS3D.
Results: Study enrolment began in October 2014 and 80 patients have been enrolled to date. First baseline characteristic data will be presented.
Conclusion: Implementation of RMP and perspective documentation of efficacy/safety data are combined in the TREAT-MS study.
Disclosure: Study supported by Genzyme, a Sanofi company.
TZ: Compensation for consulting services (Almirall, Bayer, Biogen Idec, Genzyme, GlaxoSmithKline, MSD, Merck Serono, Novartis, Sanofi, Synthon, and Teva); financial support for research activities (Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi, and Teva).
AL: Compensation as an employee (Sanofi Aventis).
SJ: Compensation as an employee (Genzyme).
RK: Compensation for consulting services (Teva, Bayer Healthcare, Genzyme, Biogen Idec, and Novartis).
UE: Compensation as an employee (Genzyme).
{{ help_message }}
By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS). USER TERMS AND CONDITIONS | PRIVACY POLICY
Cookie Settings Accept Terms & all Cookies
Anonymous User Privacy Preferences
Strictly Necessary Cookies (Always Active)
MULTILEARNING platforms and tools hereinafter referred as “MLG SOFTWARE” are provided to you as pure educational platforms/services requiring cookies to operate. In the case of the MLG SOFTWARE, cookies are essential for the Platform to function properly for the provision of education. If these cookies are disabled, a large subset of the functionality provided by the Platform will either be unavailable or cease to work as expected. The MLG SOFTWARE do not capture non-essential activities such as menu items and listings you click on or pages viewed.
Performance Cookies
Performance cookies are used to analyse how visitors use a website in order to provide a better user experience.
Google Analytics is used for user behavior tracking/reporting. Google Analytics works in parallel and independently from MLG’s features. Google Analytics relies on cookies and these cookies can be used by Google to track users across different platforms/services.