Study identification

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
First published:
01/02/2024
Institution
IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner
Multiple centres: 21 centres are involved in the study

Contact details

Marc Ferrante

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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