A Prospective Observational Study to Evaluate Long-term Safety of AMGEVITA in Patients With Rheumatoid Arthritis (20160264)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32417
• EU PAS number:
  EUPAS31796
• Study ID:
  32417
• Official title and acronym:
  A Prospective Observational Study to Evaluate Long-term Safety of AMGEVITA in Patients With Rheumatoid Arthritis (20160264)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The current study is designed to fulfill a post-authorization commitment to evaluate long-term safety of AMGEVITA and utilizes an existing registry, the BSRBR-RA. This method supports the collection of long-term safety data for new, similar biological product treatments in the postmarketing setting and is an efficient approach for conducting post-authorization safety studies (PASS).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 08/03/2019

Actual: 08/03/2019

Study start date

Planned: 15/11/2019

Actual: 15/11/2019

Data analysis start date

Planned: 02/06/2027

Date of final study report

Planned: 27/10/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20160264_01.02.06 Public Redacted Protocol Ver 1.0 2019-06-13 English

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)