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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02861118 |
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Date of registration:
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05/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease
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Scientific title:
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Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease: VERNE Study |
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Date of first enrolment:
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October 26, 2016 |
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Target sample size:
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310 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02861118 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult participants (aged =18).
- 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:
- Were participating in a clinical trial during the study reference period.
- Participant that, according to investigator's criteria was not capable to understand
and fill in the study questionnaires or to give written informed consent.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Inflammatory Bowel Disease
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Intervention(s)
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Other: No Intervention
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Primary Outcome(s)
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Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy
[Time Frame: Up to 10 weeks after start of treatment with biologics]
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Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
[Time Frame: Up to 6 months after start of treatment with biologics]
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Secondary Outcome(s)
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Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy
[Time Frame: Up to 10 weeks after start of treatment with biologics]
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Percentage of CD Participants With Comorbidities According to the Level of IBD Severity
[Time Frame: Day 1]
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Percentage of IBD Participants With Comorbidities
[Time Frame: Day 1]
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Percentage of UC Participants With Comorbidities According to the Level of IBD Severity
[Time Frame: Day 1]
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Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
[Time Frame: Up to 6 months after start of treatment with biologics]
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Secondary ID(s)
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Vedolizumab-5016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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