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- W2906202227 abstract "Objective: To report the baseline characteristics of patients with relapsing-remitting multiple sclerosis (RRMS) who enrolled in the prospective, multicenter, open-label, Phase IIIB CHORDS study (NCT02637856) evaluating the effectiveness and safety of ocrelizumab in patients who had a suboptimal response to an adequate course of a disease-modifying therapy (DMT). Background: Patients with RRMS often experience disease activity despite receiving a DMT. Ocrelizumab demonstrated superior efficacy compared with interferon beta-1a in two Phase III trials (OPERA I; OPERA II) in patients with relapsing MS. Design/Methods: Key eligibility criteria included disease duration ≤12 years, prior treatment of ≥6 months with ≥1 DMT, with exposure to ≤3 DMTs, and the discontinuation of the most recent DMT due to suboptimal disease control, defined as ≥1 clinically reported relapse, ≥1 T1 gadolinium-enhancing lesions or ≥2 new/enlarging T2 lesions. Ocrelizumab is being administered as a 600-mg intravenous infusion every 24 weeks, up to ≥96 weeks, for 4 doses, with the initial dose given as two 300-mg infusions, 14 days apart. Results: In the CHORDS study, 608 patients (72% female) were enrolled and treated, with a mean (SD) age of 37.2 (8.6) years at baseline. The mean (SD) baseline EDSS score was 2.5 (1.3); mean (SD) duration since first MS symptom onset was 5.4 (3.2) years. Most patients had received one (56%) or two (36%) DMTs prior to enrollment. The most commonly used DMT immediately before enrollment was glatiramer acetate (49%). The most frequent qualifying event for study inclusion was a clinical relapse; 44% of patients had ≥1 relapse, without evidence of MRI activity, at enrollment. Conclusions: The CHORDS study, conducted in the USA and Canada, will describe the effectiveness and safety of ocrelizumab treatment in patients who are early in their disease course and had ongoing disease activity while receiving another DMT. Study Supported by: Sponsored by Genentech, Inc. Disclosure: Dr. Reder has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Bayer, Genzyme, Genentech. Dr. Reder has received personal compensation in an editorial capacity for Medlink. Dr. Reder has received research support from Biogen, Novartis, Bayer, Malinkrodt, Serono, Genentech. Dr. Bermel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Genzyme, Genentech, Novartis. Dr. Weinstock-Guttman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bianca Weinstock- Guttman received honoraria as a speaker and as a consultant for Biogen Idec, Teva Pharmaceuticals, EMD Serono, GenzymeS Novartis, Biogen, Chugai, Alkermes, Genentech. Dr. Cutter has nothing to disclose. Dr. Stankiewicz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genentech, Genzyme, Teva neuroscience, Bayer, Novartis, Biogen Idec. Dr. Zheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Compensation from Genentech and stock in F. Hoffmann-La Roche Ltd as Genentech employee. Dr. Musch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genentech. Dr. Csoboth has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Compensation from Genentech and stock in F. Hoffmann-La Roche Ltd as Genentech employee. Dr. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with has served on advisory boards and data monitoring or steering committees, has held consulting agreements or has received speaker honoraria from AbbVie, Alkermes, Biogen, Bionest, Clene Nanomedicine, EMD Serono, Forward Pharma, MedDay, Pharmaceuticals, Nov. Dr. Wolinsky has received royalty, license fees, or contractual rights payments from royalties for monoclonal antibodies out-licensed to Chemicon International through UTHealth." @default.
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- W2906202227 date "2018-04-10" @default.
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- W2906202227 title "Baseline Characteristics of the CHORDS Study Population: A Phase III Trial to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With RRMS Who Had Disease Activity With Prior Disease-Modifying Therapies (P6.370)" @default.
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