An observational study in Ulcerative Colitis and Crohn's Disease, sponsored by University Hospital Southampton NHS Foundation Trust. Status unknown at 22 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-21.
Sponsored by University Hospital Southampton NHS Foundation Trust · Observational
Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.
Patients with inflammatory bowel disease due to start vedolizumab for the first time as part of routine therapy.
Exclusion Criteria:
Steroid-free remission
Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
Time frame: Week 56
Remission and response
Remission and response rates at week 6, 14, 30 and 54
Time frame: Multiple
Durable remission
Durable remission / response i.e. at week 14, 30 and 54
Time frame: Multiple
Effect of vedolizumab
Effect of vedolizumab on disease activity as measured by the PRO2, IBD Control PROM, Physician's Global Assessment and biomarkers of disease activity
Time frame: TBC
HES data
Healthcare usage at 1 year using HES data
Time frame: 1 year
Tolerance and safety
Tolerance and safety of vedolizumab at 1 year
Time frame: 1 year
Description of disease
Description of the demographics, disease phenotype, disease and treatment history and concomitant medication use of patients receiving vedolizumab
Time frame: TBC
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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University Hospital Southampton NHS Foundation Trust