Study identification

EU PAS number

EUPAS14135

Study ID

44109

Official title and acronym

Vedolizumab-5014: Incidence of adverse events of special interest in patients with Crohn’s disease or ulcerative colitis treated with Entyvio as compared to anti-TNF-alpha agents

DARWIN EU® study

No

Study countries

United States

Study description

Study was withdrawn prior to data collection - The drug being tested in this study is called Entyvio (vedolizumab). Vedolizumab was launched in the United States in June 2014 for treatment of people who have crohn's disease (CD) and ulcerative colitis (UC). This study will look at the real-world evidence on utilization and safety of Entyvio in routine clinical practice. The study will enroll approximately 1250 participants. The data will be taken from the Optum health insurance claims database from May 1, 2000. All participants who received one of the two treatments where included in this study: - Vedolizumab infusion - Anti-tumor necrosis factor-alpha (TNF-alpha) agent The overall time to extract the data from the Optum claims database is approximately 4 years. Participants in both groups will be followed from index date to the occurrence of last data collected, disenrollment of membership, switching to another biologic product, or date of death, whichever date comes first.

Study status

Finalised
Research institutions and networks

Institutions

Takeda
First published:
01/02/2024
Institution

Contact details

Huifang Liang

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