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

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

Amgen

Study timelines

Date when funding contract was signed

Actual: 15/02/2014

Study start date

Planned: 08/12/2014

Actual: 05/01/2015

Data analysis start date

Actual: 10/09/2015

Date of final study report

Planned: 15/04/2016

Actual: 09/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20140127 Protocol Ver 1.0 2014-09-30 English

Regulatory

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