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Baseline Characteristics of Patients with Relapsing Multiple Sclerosis in ASCLEPIOS Phase 3 Trials of Ofatumumab Versus Teriflunomide (P3.2-096)

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dc.contributor.author Kappos, Ludwig
dc.contributor.author Bar-Or, Amit
dc.contributor.author Cohen, Jeffrey A.
dc.contributor.author Comi, Giancarlo
dc.contributor.author Correale, Jorge
dc.contributor.author Coyle, Patricia K.
dc.contributor.author Cross, Anne H.
dc.contributor.author de Seze, Jerome
dc.contributor.author Montalban, Xavier
dc.contributor.author Selmaj, Krzysztof
dc.contributor.author Wiendl, Heinz
dc.contributor.author Leppert, David
dc.contributor.author Kerloeguen, Cecile
dc.contributor.author Willi, Roman
dc.contributor.author Häring, Dieter A.
dc.contributor.author Tomic, Davorka
dc.contributor.author Goodyear, Alexandra
dc.contributor.author Merschhemke, Martin
dc.contributor.author Hauser, Stephen L.
dc.date.accessioned 2020-01-10T15:29:48Z
dc.date.available 2020-01-10T15:29:48Z
dc.date.issued 2019-04-16
dc.identifier.citation Kappos L, Bar-Or A, Cohen JA, et al. Baseline Characteristics of Patients with Relapsing Multiple Sclerosis in ASCLEPIOS Phase 3 Trials of Ofatumumab Versus Teriflunomide (P3.2-096). Neurology. 2019;92(15 Supplement):P3.2-096. en_US
dc.identifier.uri https://n.neurology.org/content/92/15_Supplement/P3.2-096/tab-article-info
dc.identifier.uri https://repositorio.fleni.org.ar/handle/123456789/166
dc.description.abstract Objective: To present the baseline characteristics of patients enrolled in the ASCLEPIOS I and II trials. Background: ASCLEPIOS I and II are two Phase 3 trials of identical design that are being conducted simultaneously to evaluate the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis (RMS). Design/Methods: ASCLEPIOS I and II are randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multicenter trials in RMS patients aged 18–55 years with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at screening. Patients were randomized (1:1) to receive either ofatumumab 20 mg subcutaneous (s.c.) injections every 4 weeks (following an initial loading regimen of three 20 mg s.c. doses per week in the first 14 days) or teriflunomide 14 mg orally once daily. The primary endpoint is the annualized rate of confirmed relapses. Key secondary endpoints include 3- and 6-month confirmed disability worsening and magnetic resonance imaging (MRI)-related outcomes. The innovative, adaptive study design, with study termination occurring after reaching a prespecified number of events allows for a flexible trial duration. Results: In total, 1882 patients have been enrolled across 385 centers in 37 countries (ASCLEPIOS I, N=927; ASCLEPIOS II, N=955); the majority are female (>65%), Caucasian (>85%), and more than half (60%) had received prior disease-modifying therapy (DMT). The mean age is 38.4 and 38.1 years, and the mean duration of multiple sclerosis since the first symptom is 8.3 and 8.2 years, respectively. In each trial, the mean EDSS score is 2.9 and approximately 40% of patients showed gadolinium-enhancing lesions on brain MRI at screening. Conclusions: The trials have successfully completed patient recruitment. Baseline characteristics of enrolled patients are consistent with a typical RMS population and broadly comparable with other registration trials in RMS, with a relatively high proportion of patients being previously exposed to one or more DMTs. en_US
dc.language.iso eng en_US
dc.publisher Lippincott Williams & Wilkins en_US
dc.rights info:eu-repo/semantics/openAccess
dc.rights.uri https://creativecommons.org/licenses/by/2.5/ar/
dc.subject Multiple Sclerosis en_US
dc.subject Esclerosis Múltiple en_US
dc.subject Ofatumumab en_US
dc.subject Teriflunomide en_US
dc.subject Clinical Trial en_US
dc.subject Ensayo Clínico en_US
dc.title Baseline Characteristics of Patients with Relapsing Multiple Sclerosis in ASCLEPIOS Phase 3 Trials of Ofatumumab Versus Teriflunomide (P3.2-096) en_US
dc.type info:eu-repo/semantics/publishedVersion
dc.type info:eu-repo/semantics/other en_US
dc.description.fil Fil: Kappos, Ludwig. University Hospital and University of Basel. Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering. Neurologic Clinic and Policlinic; Suiza.
dc.description.fil Fil: Bar-Or, Amit. University of Pennsylvania. Perelman School of Medicine. Department of Neurology. Center for Neuroinflammation and Experimental Therapeutics; Estados Unidos.
dc.description.fil Fil: Cohen, Jeffrey A. Cleveland Clinic. Neurological Institute; Estados Unidos.
dc.description.fil Fil: Comi, Giancarlo. University Vita-Salute San Raffaele; Italia.
dc.description.fil Fil: Correale, Jorge. Fleni. Departamento de Neurología. Servicio de Neuroinmunología y Enfermedades Desmielinizantes; Argentina
dc.description.fil Fil: Coyle, Patricia K. Stony Brook University; Estados Unidos.
dc.description.fil Fil: Cross, Anne H. Washington University School of Medicine; Estados Unidos.
dc.description.fil Fil: de Seze, Jerome. University Hospital of Strasbourg; Francia.
dc.description.fil Fil: Montalban, Xavier. University of Toronto. St Michael’s Hospital; Estados Unidos. Hospital Universitario Vall d’Hebron. Center d’Esclerosi Múltiple de Catalunya; España.
dc.description.fil Fil: Selmaj, Krzysztof. Center for Neurology; Polonia.
dc.description.fil Fil: Wiendl, Heinz. University of Muenster; Alemania.
dc.description.fil Fil: Leppert, David. Novartis Pharma; Suiza.
dc.description.fil Fil: Kerloeguen, Cecile. Novartis Pharma; Suiza.
dc.description.fil Fil: Willi, Roman. Novartis Pharma; Suiza.
dc.description.fil Fil: Häring, Dieter A. Novartis Pharma; Suiza.
dc.description.fil Fil: Tomic, Davorka. Novartis Pharma; Suiza.
dc.description.fil Fil: Goodyear, Alexandra. Novartis Pharma; Suiza.
dc.description.fil Fil: Merschhemke, Martin. Novartis Pharma; Suiza.
dc.description.fil il: Hauser, Stephen L. University of California. UCSF Weill Institute for Neurosciences. Department of Neurology; Estados Unidos.
dc.relation.ispartofVOLUME 92
dc.relation.ispartofNUMBER 15 Supplement
dc.relation.ispartofCOUNTRY Estados Unidos
dc.relation.ispartofCITY Hagerstown
dc.relation.ispartofTITLE Neurology
dc.relation.ispartofISSN 1526-632X
dc.type.snrd info:ar-repo/semantics/artículo es_ES


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