A Retrospective Observational Study to describe the Effectiveness and Safety of Vedolizumab With or Without Budesonide Induction Therapy Among Patients with Moderate to Severe Crohn’s Disease (Vedo-BuDy)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42496
• EU PAS number:
  EUPAS28791
• Study ID:
  42496
• Official title and acronym:
  A Retrospective Observational Study to describe the Effectiveness and Safety of Vedolizumab With or Without Budesonide Induction Therapy Among Patients with Moderate to Severe Crohn’s Disease (Vedo-BuDy)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Israel

  Switzerland
• Study description:
  This is a retrospective, multi-national, multi-center medical chart review study of patients diagnosed with moderate to severe Crohn’s disease (CD). This study will review medical records of patients who initiated vedolizumab (VDZ) induction therapy either as VDZ-only or VDZ with budesonide following standard practice, between 01 January 2015 and 31 January 2019 and having a minimum of 14 weeks follow-up. The study will assess the real-world effectiveness and safety, and will describe moderate to severe CD patient profile following induction therapy using VDZ in combination with budesonide and VDZ alone. The data for patients will be collected in two main periods: Pre‐index Event Period (Begins on the date of diagnosis of CD), and Post‐index Event Period (Begins one day after the Index Date and ends at the earliest of death, lost to follow‐up, or 14 weeks after the Index Date). The index period is defined as the date when VDZ induction therapy was initiated. This study will enroll approximately 200 patients. This multi-center study will be conducted in Belgium, Switzerland, and Israel. The overall duration to collect the data in this study is approximately 10 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

IQVIA

United Kingdom

Multiple centres: 21 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/03/2019

Actual: 11/07/2018

Study start date

Planned: 31/07/2019

Actual: 07/08/2019

Data analysis start date

Planned: 17/08/2020

Actual: 13/08/2020

Date of final study report

Planned: 30/06/2021

Actual: 13/08/2020

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