Study identification

EU PAS number

EUPAS1000000767

Study ID

1000000767

Official title and acronym

Vedolizumab-4081: Infection Outcomes among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025

DARWIN EU® study

No

Study countries

United States

Study description

More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn’s Disease (CD). This is happening because people are living longer and because more people overall are developing Ulcerative Colitis (CD) or Crohn’s Disease (CD). Medicines that treat UC/CD, however, might make it easier for older adults to get infections.

The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (called TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).

The study will include people aged 65 years and older with UC or CD who used either ENTYVIO or a TNF-alpha inhibitor or ustekinumab between 2016 and 2025.

Data will be collected from existing Medicare databases.

Study status

Planned
Research institutions and networks

Institutions

Takeda
First published:
01/02/2024
Institution

Contact details

Study Contact Takeda

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
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