Early Experience with Etrasimod in Ulcerative Colitis Patients: an Observational Study in the United States

Study identification

• EU PAS number:
  EUPAS1000000587
• Study ID:
  1000000587
• Official title and acronym:
  Early Experience with Etrasimod in Ulcerative Colitis Patients: an Observational Study in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a population-based retrospective cohort study of adults (ages ≥ 18 years of age) with ulcerative colitis (UC) initiating treatment with etrasimod since its marketing authorization, using claims data from a large United States (US) database. ; Primary endpoint is baseline characteristics of patients. Secondary endpoints are adherence, measured by proportion of days covered method, persistence (delay until etrasimod discontinuation), the use of corticosteroids and change in level of fecal calprotectin, within 12 months of etrasimod initiation.;
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:27/05/2025

Study start date

Planned:08/09/2025

Data analysis start date

Planned:08/09/2025

Date of final study report

Planned:30/10/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C5041059