Experiences of using vedolizumab in the East Midlands, United Kingdom: A retrospective observational study

Study identification

• EU PAS number:
  EUPAS23658
• Study ID:
  48537
• Official title and acronym:
  Experiences of using vedolizumab in the East Midlands, United Kingdom: A retrospective observational study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is a retrospective, observational study to investigate the use of vedolizumab and treatment outcomes in patients with inflammatory bowel disease (IBD) in the East Midlands. This study will utilize patient-level data in the East Midlands. Approximately 200 patients with IBD will be included in this study. Patients who were initiated on vedolizumab treatment between 1st November 2014 and 30th November 2016 will be followed up to the earliest of the following dates: last follow-up, date of death (if applicable) or 31st March 2017.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Nottingham University Hospitals NHS Trust United Kingdom, Chesterfield Royal Hospital NHS Foundation Trust United Kingdom, Derby Teaching Hospitals NHS Foundation Trust United Kingdom, Kettering General Hospital NHS Foundation Trust United Kingdom, Sherwood Forest Hospitals NHS Foundation Trust United Kingdom, United Lincolnshire Hospitals NHS Trust United Kingdom, University Hospitals of Leicester NHS Trust United Kingdom

Study timelines

Date when funding contract was signed

Planned: 25/10/2017

Actual: 25/10/2017

Study start date

Planned: 21/05/2018

Actual: 01/06/2018

Data analysis start date

Planned: 04/06/2018

Actual: 31/07/2018

Date of final study report

Planned: 31/08/2018

Actual: 31/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable