Study identification

PURI

https://redirect.ema.europa.eu/resource/48143

EU PAS number

EUPAS6469

Study ID

48143

Official title and acronym

MLN-0002_401: Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease (Entyvio PASS study)

DARWIN EU® study

No

Study countries

Austria
Belgium
Canada
Croatia
Denmark
Estonia
France
Germany
Greece
Ireland
Israel
Italy
Netherlands
Norway
Portugal
Slovenia
Spain
Sweden
Switzerland
United Kingdom
United States

Study description

This study is a non-interventional prospective cohort study to compare the safety of long-term treatment with vedolizumab, with the safety of long-term treatment with other biologic agents for ulcerative colitis (UC) or Crohn's Disease (CD). 5,000 patients will be recruited and followed for up to 7 years, with 6-monthly clinic visits at which information will be collected on adverse events, UC/CD disease management, and comorbidities.

Study status

Finalised
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:
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
Study protocol
Initial protocol

Vedolizumab PASS study (MLN-002-401) protocol Final_v1_2

English (437.28 KB - PDF)View document
Updated protocol

MLN0002_401-Protocol-V3.1-Redacted

English (7.91 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)