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
First published:
21/02/2024
Institution
Mass General Brigham
Cleveland Clinic Foundation’s Center for Vasculitis Care and Research

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.
Study protocol
Initial protocol
English (603.86 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only