Study identification

PURI

https://redirect.ema.europa.eu/resource/15158

EU PAS number

EUPAS8054

Study ID

15158

Official title and acronym

Burden of serious infection in patients with rheumatoid arthritis treated with Prolia ovserved in a clinical setting (20140127)

DARWIN EU® study

No

Study countries

Canada

Study description

This is a retrospective observational study to describe the occurrence of serious infection in RA patients in a Canadian medical practice treated concomitantly with both an immunosuppressive biologic agent and Prolia.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Amgen

Contact details

Global Development Leader Amgen, Inc

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (483.37 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