Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study
IntroductionA 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 analysisA prospective, multicentre, observational, cohort study of 300 patients prescribed budesonide MMX for the...
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| Veröffentlicht in: | BMJ open gastroenterology 2016-01, Vol.3 (1), p.e000092-e000092 |
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| creator | Danese, Silvio Hart, Ailsa Dignass, Axel Louis, Edouard D'Haens, Geert Dotan, Iris Rogler, Gerhard D'Agay, Laurence Iannacone, Claudio Peyrin-Biroulet, Laurent |
| description | IntroductionA 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 analysisA 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 ≤8 weeks. Data on effectiveness, including patient-reported outcomes, tolerability and use will be recorded at the end of treatment and at ≥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 ≤2 weeks since mesalazine increased/optimised for the treatment of flare, or without mesalazine dose modification (early add-on); and patients who receive budesonide MMX as monotherapy for the treatment of flare (mono). Propensity scoring will be used to minimise bias and confounding inherent in observational studies.Ethics and disseminationFirst ethical approval: Ethikkommission der Ärztekammer Hamburg (12/22/2015). The results will be published in full.DiscussionCompletion of primary data collection is expected in December 2017. Our results will provide further evidence on the effectiveness of budesonide MMX to support clinicians in their daily practice and inform therapeutic guidelines.Trial registration numberNCT02586259. |
| doi_str_mv | 10.1136/bmjgast-2016-000092 |
| format | Article |
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Patients will be treated with budesonide MMX9 mg daily for induction of remission for ≤8 weeks. Data on effectiveness, including patient-reported outcomes, tolerability and use will be recorded at the end of treatment and at ≥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 ≤2 weeks since mesalazine increased/optimised for the treatment of flare, or without mesalazine dose modification (early add-on); and patients who receive budesonide MMX as monotherapy for the treatment of flare (mono). Propensity scoring will be used to minimise bias and confounding inherent in observational studies.Ethics and disseminationFirst ethical approval: Ethikkommission der Ärztekammer Hamburg (12/22/2015). The results will be published in full.DiscussionCompletion of primary data collection is expected in December 2017. Our results will provide further evidence on the effectiveness of budesonide MMX to support clinicians in their daily practice and inform therapeutic guidelines.Trial registration numberNCT02586259.</description><identifier>ISSN: 2054-4774</identifier><identifier>EISSN: 2054-4774</identifier><identifier>DOI: 10.1136/bmjgast-2016-000092</identifier><identifier>PMID: 27239329</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Cohort analysis ; Colon ; Endoscopy ; Gastroenterology & hepatology ; Gastroentérologie & hépatologie ; Human health sciences ; IBD CLINICAL ; INFLAMMATORY BOWEL DISEASE ; Joint surgery ; Life Sciences ; Observational studies ; Patient satisfaction ; Product development ; Quality of life ; Questionnaires ; Sciences de la santé humaine ; Studies ; ULCERATIVE COLITIS</subject><ispartof>BMJ open gastroenterology, 2016-01, Vol.3 (1), p.e000092-e000092</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016 BMJ Open Gastroenterology This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2016 BMJ Open Gastroenterology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b550t-e37d95fa9d919adb27e81726fd1b720a3167ea91e43ac560d3c42124d7a1eec03</citedby><cites>FETCH-LOGICAL-b550t-e37d95fa9d919adb27e81726fd1b720a3167ea91e43ac560d3c42124d7a1eec03</cites><orcidid>0000-0003-2536-6618</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjopengastro.bmj.com/content/3/1/e000092.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjopengastro.bmj.com/content/3/1/e000092.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27549,27550,27924,27925,53791,53793,77601,77632</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27239329$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.univ-lorraine.fr/hal-01662125$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Danese, Silvio</creatorcontrib><creatorcontrib>Hart, Ailsa</creatorcontrib><creatorcontrib>Dignass, Axel</creatorcontrib><creatorcontrib>Louis, Edouard</creatorcontrib><creatorcontrib>D'Haens, Geert</creatorcontrib><creatorcontrib>Dotan, Iris</creatorcontrib><creatorcontrib>Rogler, Gerhard</creatorcontrib><creatorcontrib>D'Agay, Laurence</creatorcontrib><creatorcontrib>Iannacone, Claudio</creatorcontrib><creatorcontrib>Peyrin-Biroulet, Laurent</creatorcontrib><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</title><title>BMJ open gastroenterology</title><addtitle>BMJ Open Gastroenterol</addtitle><description>IntroductionA 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 analysisA 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 ≤8 weeks. Data on effectiveness, including patient-reported outcomes, tolerability and use will be recorded at the end of treatment and at ≥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 ≤2 weeks since mesalazine increased/optimised for the treatment of flare, or without mesalazine dose modification (early add-on); and patients who receive budesonide MMX as monotherapy for the treatment of flare (mono). Propensity scoring will be used to minimise bias and confounding inherent in observational studies.Ethics and disseminationFirst ethical approval: Ethikkommission der Ärztekammer Hamburg (12/22/2015). The results will be published in full.DiscussionCompletion of primary data collection is expected in December 2017. 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Hart, Ailsa ; Dignass, Axel ; Louis, Edouard ; D'Haens, Geert ; Dotan, Iris ; Rogler, Gerhard ; D'Agay, Laurence ; Iannacone, Claudio ; Peyrin-Biroulet, Laurent</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b550t-e37d95fa9d919adb27e81726fd1b720a3167ea91e43ac560d3c42124d7a1eec03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Cohort analysis</topic><topic>Colon</topic><topic>Endoscopy</topic><topic>Gastroenterology & hepatology</topic><topic>Gastroentérologie & hépatologie</topic><topic>Human health sciences</topic><topic>IBD CLINICAL</topic><topic>INFLAMMATORY BOWEL DISEASE</topic><topic>Joint surgery</topic><topic>Life Sciences</topic><topic>Observational studies</topic><topic>Patient satisfaction</topic><topic>Product development</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Sciences de la santé humaine</topic><topic>Studies</topic><topic>ULCERATIVE COLITIS</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Danese, Silvio</creatorcontrib><creatorcontrib>Hart, Ailsa</creatorcontrib><creatorcontrib>Dignass, Axel</creatorcontrib><creatorcontrib>Louis, Edouard</creatorcontrib><creatorcontrib>D'Haens, Geert</creatorcontrib><creatorcontrib>Dotan, Iris</creatorcontrib><creatorcontrib>Rogler, Gerhard</creatorcontrib><creatorcontrib>D'Agay, Laurence</creatorcontrib><creatorcontrib>Iannacone, Claudio</creatorcontrib><creatorcontrib>Peyrin-Biroulet, Laurent</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>Université de Liège - Open Repository and Bibliography (ORBI)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Danese, Silvio</au><au>Hart, Ailsa</au><au>Dignass, Axel</au><au>Louis, Edouard</au><au>D'Haens, Geert</au><au>Dotan, Iris</au><au>Rogler, Gerhard</au><au>D'Agay, Laurence</au><au>Iannacone, Claudio</au><au>Peyrin-Biroulet, Laurent</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study</atitle><jtitle>BMJ open gastroenterology</jtitle><addtitle>BMJ Open Gastroenterol</addtitle><date>2016-01-01</date><risdate>2016</risdate><volume>3</volume><issue>1</issue><spage>e000092</spage><epage>e000092</epage><pages>e000092-e000092</pages><issn>2054-4774</issn><eissn>2054-4774</eissn><abstract>IntroductionA 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 analysisA 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 ≤8 weeks. Data on effectiveness, including patient-reported outcomes, tolerability and use will be recorded at the end of treatment and at ≥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 ≤2 weeks since mesalazine increased/optimised for the treatment of flare, or without mesalazine dose modification (early add-on); and patients who receive budesonide MMX as monotherapy for the treatment of flare (mono). Propensity scoring will be used to minimise bias and confounding inherent in observational studies.Ethics and disseminationFirst ethical approval: Ethikkommission der Ärztekammer Hamburg (12/22/2015). The results will be published in full.DiscussionCompletion of primary data collection is expected in December 2017. Our results will provide further evidence on the effectiveness of budesonide MMX to support clinicians in their daily practice and inform therapeutic guidelines.Trial registration numberNCT02586259.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>27239329</pmid><doi>10.1136/bmjgast-2016-000092</doi><orcidid>https://orcid.org/0000-0003-2536-6618</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Cohort analysis Colon Endoscopy Gastroenterology & hepatology Gastroentérologie & hépatologie Human health sciences IBD CLINICAL INFLAMMATORY BOWEL DISEASE Joint surgery Life Sciences Observational studies Patient satisfaction Product development Quality of life Questionnaires Sciences de la santé humaine Studies ULCERATIVE COLITIS |
| 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 |
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