Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis A phase 2 study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10227286" target="_blank" >RIV/00216208:11110/14:10227286 - isvavai.cz</a>

Alternative codes found

RIV/00064165:_____/14:10227286

Result on the web

<a href="http://dx.doi.org/10.1212/WNL.0000000000000125" target="_blank" >http://dx.doi.org/10.1212/WNL.0000000000000125</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1212/WNL.0000000000000125" target="_blank" >10.1212/WNL.0000000000000125</a>

Result language

angličtina

Original language name

Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis A phase 2 study

Original language description

Objectives:We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS).Methods:In this randomized, double-blind, placebo-controlled study, patients received 2ofatumumab infusions (100 mg, 300 mg, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and efficacy were assessed.Results:Thirty-eight patients were randomized (ofatumumab/placebo, n = 26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the study. Two patients in the 300-mg group withdrew from the study because of adverse events. No unexpected safety signals emerged. Infusion-related reactions were common on the first infusion day but not observed onthe second infusion day. None of the patients developed human anti-human antibodies. Ofatumumab was associated with profound selective reduction of B cells as measured by CD19(+) expression. New brain MRI lesion activity was suppressed (

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FH - Neurology, neuro-surgery, nuero-sciences

OECD FORD branch

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Project

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Continuities

Z - Vyzkumny zamer (s odkazem do CEZ)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2014

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Neurology

ISSN

0028-3878

e-ISSN

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Volume of the periodical

82

Issue of the periodical within the volume

7

Country of publishing house

US - UNITED STATES

Number of pages

9

Pages from-to

573-581

UT code for WoS article

000336498300008

EID of the result in the Scopus database

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