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Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study.
Danese, Silvio; Hart, Ailsa; Dignass, Axel et al.
2016 • In BMJ Open Gastroenterology, 3 (1), p. 000092
Peer Reviewed verified by ORBi
Permalink
https://hdl.handle.net/2268/205982
DOI
10.1136/bmjgast-2016-000092
PubMed
27239329
 

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Keywords :
IBD CLINICAL; INFLAMMATORY BOWEL DISEASE; ULCERATIVE COLITIS
Abstract :
[en] INTRODUCTION: A study has been developed to assess the use and effectiveness of budesonide MMX for mild-to-moderate active ulcerative colitis (UC) in routine clinical practice. METHODS AND ANALYSIS: A prospective, multicentre, observational, cohort study of 300 patients prescribed budesonide MMX for the treatment of mild-to-moderate active UC will be conducted in Europe, Israel and Canada. Patients will be treated with budesonide MMX9 mg daily for induction of remission for /=2 weeks after. The primary outcome (improvement >/=3 point in the clinical subscores of the UC Disease Activity Index score at the end of treatment) will be compared in: patients who receive budesonide MMX added to mesalazine >2 weeks after increased/optimised mesalazine dose for the treatment of flare (late add-on); patients who receive budesonide MMX added to mesalazine
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Danese, Silvio
Hart, Ailsa
Dignass, Axel
Louis, Edouard  ;  Université de Liège > Département des sciences cliniques > Hépato-gastroentérologie
D'Haens, Geert
Dotan, Iris
Rogler, Gerhard
D'Agay, Laurence
Iannacone, Claudio
Peyrin-Biroulet, Laurent
Language :
English
Title :
Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study.
Publication date :
2016
Journal title :
BMJ Open Gastroenterology
eISSN :
2054-4774
Publisher :
BMJ Publishing Group, Londres, United Kingdom
Volume :
3
Issue :
1
Pages :
e000092
Peer reviewed :
Peer Reviewed verified by ORBi
Additional URL :
http://bmjopengastro.bmj.com/
Available on ORBi :
since 26 January 2017

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