Retrospective UK Chart Review of Early Vedolizumab Experience
Research type
Research Study
Full title
A Retrospective UK Chart Review of Early Vedolizumab (Entyvio®) Experience: Real World Treatment, Effectiveness and Safety in Inflammatory Bowel Disease (IBD)
IRAS ID
197199
Contact name
Helen Cardy
Contact email
Sponsor organisation
Takeda UK Ltd
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
This is an observational, retrospective, multicentre, descriptive research study. The target patient group will be patients either currently treated or previously treated with vedolizumab for Ulcerative Colitis (UC) or Crohns Disease (CD).
The study will take place in 6 centres in the UK and will recruit between 80 and 200 patients. The centres will be secondary/tertiary care hospitals.
This observational study will collect retrospective information relating to duration of treatment and treatment response at various time points.
Retrospective data will be collected from patients’ medical records by trained data collectors. All living patients will be invited to consent to allow a researcher access to their medical records for the purpose of data collection. Since no consent can be obtained where the patient is deceased and contacting the relatives of deceased patients is likely to cause distress, in these situations members of the direct care team will collect the data from identifiable records and provide anonymised data to researchers for analysis.REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0032
Date of REC Opinion
20 Jan 2016
REC opinion
Favourable Opinion