A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease
NCT ID: NCT02861118
Last Updated: 2019-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
310 participants
OBSERVATIONAL
2016-10-26
2018-04-04
Brief Summary
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Detailed Description
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The study enrolled 310 patients included both UC and CD patients.
This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: Crohn's Disease
Participants with Crohn's disease who received biological treatment between June 2011 and June 2013.
No Intervention
Cohort 2: Ulcerative Colitis
Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013.
No Intervention
Interventions
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No Intervention
Eligibility Criteria
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Inclusion Criteria
* Were diagnosed with UC or CD according to the "World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of inflammatory bowel disease (IBD) in 2010".
* Who were naive to biologics that started treatment with biologics between June 2011 and June 2013.
* Participants in whom biological treatment was prescribed according to clinical practice.
* Who gave written informed consent.
Exclusion Criteria
* Participant that, according to investigator's criteria was not capable to understand and fill in the study questionnaires or to give written informed consent.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Santiago de Compostela, A Coruna, Spain
Huesca, Aragon, Spain
Alcázar de San Juan, Ciudad Real, Spain
Girona, Gerona, Spain
Las Palmas, Gran Canaria, Spain
Alcorcón, Madrid, Spain
Fuenlabrada, Madrid, Spain
Parla, Madrid, Spain
Pamplona, Navarre, Spain
Vigo, Pontevedra, Spain
Gijón, Principality of Asturias, Spain
Castellon, Valencia, Spain
Sagunto, Valencia, Spain
Barakaldo, Vizcaya, Spain
Barcelona, , Spain
Burgos, , Spain
Ciudad Real, , Spain
Madrid, , Spain
Murcia, , Spain
Santander, , Spain
Seville, , Spain
Valencia, , Spain
Valladolid, , Spain
Countries
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References
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Marin-Jimenez I, Bastida G, Fores A, Garcia-Planella E, Arguelles-Arias F, Sarasa P, Tagarro I, Fernandez-Nistal A, Montoto C, Aguas M, Santos-Fernandez J, Bosca-Watts MM, Ferreiro R, Merino O, Aldeguer X, Cortes X, Sicilia B, Mesonero F, Barreiro-de Acosta M. Impact of comorbidities on anti-TNFalpha response and relapse in patients with inflammatory bowel disease: the VERNE study. BMJ Open Gastroenterol. 2020 Mar 26;7(1):e000351. doi: 10.1136/bmjgast-2019-000351. eCollection 2020.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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Vedolizumab-5016
Identifier Type: -
Identifier Source: org_study_id
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