Retrospective Cohort Study Evaluating Clinical Outcomes in Patients with Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA) Treated with Avacopan (20230026)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000065
• EU PAS number:
  EUPAS1000000065
• Study ID:
  1000000065
• Official title and acronym:
  Retrospective Cohort Study Evaluating Clinical Outcomes in Patients with Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA) Treated with Avacopan (20230026)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Mass General Brigham
Cleveland Clinic Foundation’s Center for Vasculitis Care and Research

Study timelines

Date when funding contract was signed

Planned: 29/09/2023

Actual: 27/10/2023

Study start date

Planned: 02/04/2024

Actual: 02/04/2024

Data analysis start date

Planned: 01/04/2024

Actual: 02/04/2024

Date of final study report

Planned: 03/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

Redacted Protocol-Published Original avacopan 20230026 .pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

20230026