Vedolizumab-5028: A Retrospective UK Chart Review of Early Vedolizumab (Entyvio®) Experience: Real World Treatment, Effectiveness and Safety in Inflammatory Bowel Disease (IBD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44112
• EU PAS number:
  EUPAS12537
• Study ID:
  44112
• Official title and acronym:
  Vedolizumab-5028: A Retrospective UK Chart Review of Early Vedolizumab (Entyvio®) Experience: Real World Treatment, Effectiveness and Safety in Inflammatory Bowel Disease (IBD)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is retrospective, observational, multi-center study of patients with ulcerative colitis (UC) and Crohn's disease (CD), will be conducted based on the secondary data derived from patients medical records and hospital databases. Patients who meet the eligibility criteria will be selected from a total of 6 NHS study across the United Kingdom. Patients who were on vedolizumab treatment initiated 10 to 14 weeks prior to start of data collection in order to allow adequate time to observe the response to treatment. Treatment response will be assessed at Week 10 and Week 14 for patients with UC and CD respectively. The study is aimed to evaluate the effectiveness, patterns of use and tolerability of vedolizumab in real world treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Multiple centres: 6 centres are involved in the study

Networks

pH Associates

Study timelines

Date when funding contract was signed

Planned: 23/02/2016

Actual: 16/09/2015

Study start date

Planned: 07/03/2016

Actual: 22/04/2016

Date of final study report

Planned: 31/05/2016

Actual: 14/11/2017

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