Document Detail


Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis.
MedLine Citation:
PMID:  20200197     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This study evaluated the efficacy of a new formulation of subcutaneous (sc) interferon (IFN)-beta1a in relapsing-remitting multiple sclerosis (RRMS). Patients (n = 180) were randomized (2 : 1) to IFN-beta1a or placebo for 16 weeks; all patients then received IFN-beta1a for 24 weeks. Monthly brain MRI was performed. At week 16, the mean number of combined unique active (CUA) lesions was lower with IFN-beta1a than with placebo (p < 0.001; 69% fewer lesions). The mean cumulative number of CUA lesions was already lower with IFN-beta1a by week 4 (post hoc analysis; p = 0.015). The new formulation of sc IFN-beta1a has rapid beneficial effects on MRI outcomes in RRMS.
Authors:
Nicola De Stefano; François Curtin; Bettina Stubinski; Gregg Blevins; Jelena Drulovic; Delphine Issard; Penko Shotekov; Claudio Gasperini;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-03-03
Journal Detail:
Title:  Multiple sclerosis (Houndmills, Basingstoke, England)     Volume:  16     ISSN:  1477-0970     ISO Abbreviation:  Mult. Scler.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-12     Completed Date:  2010-10-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9509185     Medline TA:  Mult Scler     Country:  England    
Other Details:
Languages:  eng     Pagination:  888-92     Citation Subset:  IM    
Affiliation:
Department of Neurological and Behavioral Sciences, University of Siena, Siena, Italy. destefano@unisi.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00441103
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MeSH Terms
Descriptor/Qualifier:
Brain / drug effects,  pathology
Chemistry, Pharmaceutical
Double-Blind Method
Europe
Humans
Immunologic Factors / administration & dosage*
Injections, Subcutaneous
Interferon-beta / administration & dosage*
Magnetic Resonance Imaging
Multiple Sclerosis, Relapsing-Remitting / drug therapy*,  pathology
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Immunologic Factors; 145258-61-3/interferon beta 1a; 77238-31-4/Interferon-beta
Investigator
Investigator/Affiliation:
S Bojinov / ; N Deleva / ; L Haralanov / ; I Milanov / ; I Petrov / ; P Shotekov / ; Z Zahariev / ; P Duquette / ; G Blevins / ; K Gross-Paju / ; S Haldre / ; H Tumani / ; G Mancardi / ; C Gasperini / ; R Kizlaitiene / ; M Ticmeanu / ; A Boyko / ; I Poverennova / ; I Stolyarov / ; E Zonova / ; J Drulovic / ; G Toncev / ; D Muñoz / ; A Saiz / ; A Tuñón /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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