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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
ECTRIMS Online Library.
Ziemssen T.
Oct 9, 2015; 115890
Abstract
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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).
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).
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