A Canadian Study Assessing the Utility of the Treatment Optimization Recommendations in Multiple...
Multiple SclerosisRelapsing-RemittingThe Canadian Multiple Sclerosis Working Group (CMSWG) has developed practical recommendations on how neurologists can assess the status of subjects on disease modifying drugs (DMDs) and decide when it may be necessary to modify treatment in order to optimize outcomes. These recommendations are based on relapses, disease progression as measured by the Expanded Disability Status Scale (EDSS) or EDSS progression, and magnetic resonance imaging (MRI) outcomes. The CMSWG agreed to compare post-treatment relapse rates and severity to baseline rates and severity in each individual subject. The recommended minimum baseline reference time frame needed to assess relapse rate was 2 years prior to treatment initiation. The objective and prospective relapse data should be ideally collected during this reference period. The CMSWG recommended that the following should be taken into consideration when assessing relapse severity: the effect of the relapse on activities of daily living (ADL), the type and number of systems involved (i.e., relapses that are polysymptomatic or that affect the cerebellar/motor systems tend to be more severe), and whether or not a course of corticosteroids was required. The CMSWG also recommended that, prior to considering treatment modification on the basis of progression in disability, progression should be confirmed at 6 months. The CMSWG's Treatment Optimization Recommendations (TORs) have been retrospectively applied to the 4 year data set from the PRISMS study. Applying the model to subjects after their first year on therapy allowed for accurate prediction of continued disease activity in the form of relapses in the majority of subjects who actually experienced ongoing attacks. The model was less effective in predicting disability progression, but this may well have been due to the low numbers of subjects on treatment progressing over the study period. This observational study used the TOR model to identify subjects as either candidates for therapy optimization or as candidates to maintain current therapy. All subjects were then followed prospectively until re- assessment will be done with this model.
Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization...
Multiple SclerosisThe primary objective of this study is to define the effect of Tysabri in patients with relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also explore the extent of remyelination in MS patients treated with Tysabri over 2 years. A secondary objective of this study is to investigate differences in the capacity for remyelination between patients who do or do not respond to Tysabri monotherapy during the same 24 months. A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid antibodies positive and MS antiphospholipid antibodies negative patients and to determine perfusion differences according to the antiphospholipid antibodies positivity status.
Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
Multiple SclerosisMultiple Sclerosis3 moreThe aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging. In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)...
Relapsing-remitting Multiple SclerosisThe purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).
Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple...
Multiple SclerosisThe primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF). Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.
Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient...
Multiple SclerosisRelapsing-RemittingThe primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively. The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively; For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.
Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma)...
Relapsing Remitting Multiple SclerosisThe purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing routine clinical care for RRMS in MENA Region
Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities
Relapsing Remitting Multiple SclerosisThe incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis population than in general population. These MS patients category response unfavorably to the Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological marker predicting good response to GA.
Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment...
Multiple SclerosisRelapsing-RemittingMultiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
An Observational Study for the Assessment of Compliance and Persistence to Rebif® Therapy of Patients...
Multiple SclerosisRelapsing-RemittingThe present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions.