Study identification

EU PAS number

EUPAS1000000895

Study ID

1000000895

Official title and acronym

An Active Surveillance, Post-Authorization Safety Study to Characterize the Safety of Etrasimod in Patients with Ulcerative Colitis Using Real-World Data in the European Union (C5041046)

DARWIN EU® study

No

Study countries

Germany
Netherlands
Sweden

Study description

This multi‑country, non‑interventional Post‑Authorization Safety Study (PASS) aims to characterize the real‑world safety of etrasimod (Velsipity®) among patients aged 16 years and older with ulcerative colitis (UC) across Germany, Sweden, and the Netherlands. Using electronic health records, healthcare claims, and registry data, the study follows new users of etrasimod and comparator therapies—including other S1P receptor modulators, biologics, and JAK inhibitors—to estimate incidence rates of key safety outcomes such as macular oedema, serious liver injury, malignancy, serious opportunistic infections, neurologic events including PRES or convulsions, and symptomatic bradycardia. The study describes patient characteristics at treatment initiation, compares incidence rates between etrasimod and comparator cohorts when sample size allows, and evaluates safety in adults aged 65 years and older by assessing rates of eye adverse events, infections, and cardiovascular events.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Shahar Shmuel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
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)