Occurrence of serious infection among patients with rheumatoid arthritis or psoriatic arthritis concurrently exposed to an immunosuppressive biologic and denosumab: US physician practice chart review study (20150207)

Study identification

• EU PAS number:
  EUPAS11662
• Study ID:
  20935
• Official title and acronym:
  Occurrence of serious infection among patients with rheumatoid arthritis or psoriatic arthritis concurrently exposed to an immunosuppressive biologic and denosumab: US physician practice chart review study (20150207)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will be conducted to describe the occurrence of serious infections in patients with rheumatoid arthritis or psoriatic arthritis who are concurrently treated with an immunosuppressive biologic and denosumab at two rheumatology clinics in the United States.
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Clinical Research (Canada)

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:10/04/2015

Study start date

Planned:07/12/2015

Actual:20/02/2016

Data analysis start date

Planned:31/07/2016

Actual:13/09/2016

Date of final study report

Planned:13/09/2017

Actual:11/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen, Inc

Regulatory

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