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)

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

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Networks

The SIGMA Consortium (SIGMA)

Denmark

European Union

France

Germany

Italy

Netherlands

Norway

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:23/01/2024

Actual:23/01/2024

Study start date

Planned:15/11/2026

Data analysis start date

Planned:01/07/2035

Date of interim report, if expected

Planned:16/05/2028

Date of final study report

Planned:31/12/2035

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)

Other study registration identification numbers and links

C5041046