Study identification

EU PAS number

EUPAS25761

Study ID

47153

Official title and acronym

Retrospective observational study on the effect of vedolizumab treatment on patients with inflammatory bowel disease and extraintestinal manifestations. The EMOTIVE study

DARWIN EU® study

No

Study countries

Belgium
Denmark
Israel
Netherlands
Switzerland

Study description

This is retrospective multi-national, multi-centre medical chart review study of patients with inflammatory bowel disease (IBD) and extraintestinal manifestations (EIMs) who have initiated treatment with vedolizumab between 01 January 2015 and 31 December 2016. The study will review the medical charts of patients who have initiated the medical treatment with vedolizumab during the defined eligibility period under standard clinical practice to provide the real-world evidence of treatment effectiveness and safety in the adult patients with ulcerative colitis (UC) or Crohn’s disease (CD) and EIMs. Patients who will be taking vedolizumab as per the standard clinical practice will be observed in this study. The data for participants will be collected in two main periods: Pre-index event period (from the data of diagnosis of UC or CD until one day prior to the date when vedolizumab treatment was initiated during the eligibility period), and Post-index event period (from the date when vedolizumab treatment was initiated during the eligibility period until the death of participants, lost-to-follow up, or date of chart abstraction initiation). The overall duration of the study will be 14 months.

Study status

Finalised
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner
Sheba Medical Center, Meir Medical Center, Tel Aviv Medical Center Israel, Asaf Harofeh medical center, Soroka university medical center, Rambam Medical Center Israel, Zentrum für Gastroenterologie und Hepatologie AG, Centre Hospitalier Universitaire Vaudois Switzerland, University Hospital Zurich, University Hospital Basel, Gastroenterologische Praxis Balsiger, Seibold und Partner Switzerland, LUMC Leiden, Zuyderland ziekenhuis Heerlen, ETZ Netherlands, CHC - Saint Joseph, AZ Groeninge Kortrijk, OLVZ Belgium, Bispebjerg Hospital, Hvidvore University Hospital Denmark, Hvidvore University Hospital Denmark

Contact details

Stephan Vavricka

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
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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