Burden of Illness Among Patients with Gout and Treated with Pegloticase (20240302)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000475
• EU PAS number:
  EUPAS1000000475
• Study ID:
  1000000475
• Official title and acronym:
  Burden of Illness Among Patients with Gout and Treated with Pegloticase (20240302)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective cohort study will describe patient characteristics and treatment patterns and compare gout flares, laboratory measures, and HCRU and cost between the pre- and post-pegloticase initiation periods among gout patients in a real-world setting using administrative claims data from the MORE2 Registry® and the 100% Medicare FFS database. The objective of the study are 1. To describe the patient characteristics of pegloticase initiators. 2. To examine the treatment patterns pre and post pegloticase initiation. 3. To assess gout- and flare-related healthcare resource utilization and costs pre- and post-pegloticase initiation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Inovalon (Vendor)

Study timelines

Date when funding contract was signed

Planned: 22/08/2024

Actual: 22/08/2024

Study start date

Planned: 17/02/2025

Actual: 17/02/2025

Data analysis start date

Planned: 17/02/2025

Actual: 17/02/2025

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

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