Temporal trends in pegloticase infusion reactions across the pre, intra, and post-COVID-19 vaccine eras in U.S. commercial insurance claims (20250232)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001008
• Study ID:
  1000001008
• Official title and acronym:
  Temporal trends in pegloticase infusion reactions across the pre, intra, and post-COVID-19 vaccine eras in U.S. commercial insurance claims (20250232)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective temporal trend study evaluates annual and era specific incidence rates of severe infusion reactions among new users of pegloticase with immunomodulator co therapy from 2017–2025. Analyses assess population level trends across pre , intra , and post–COVID 19 vaccination periods, with sensitivity analysis in pegloticase monotherapy users.
• Study status:
  Planned

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned:26/03/2026

Study start date

Planned:10/08/2026

Data analysis start date

Planned:10/08/2026

Date of interim report, if expected

Planned:15/12/2026

Date of final study report

Planned:31/03/2027

Sources of funding

Other

More details on funding

Amgen/CfOR Internal Study

Regulatory

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