Post-marketing Study Assessing the Long-term Safety of Abatacept

Study identification

• EU PAS number:
  EUPAS8718
• Study ID:
  18489
• Official title and acronym:
  Post-marketing Study Assessing the Long-term Safety of Abatacept
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study that will be conducted using administrative health care databases in the United States to estimate and compare the risk of malignancies and infections among patients exposed to abatacept and patients exposed to other treatments for rheumatoid arthritis (RA).
• Study status:
  Finalised

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Study timelines

Date when funding contract was signed

Actual:08/10/2013

Study start date

Planned:01/06/2014

Actual:01/06/2014

Date of final study report

Planned:31/12/2016

Actual:27/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

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