An Analysis of Real-World Data on the Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis

Study identification

• EU PAS number:
  EUPAS25655
• Study ID:
  25656
• Official title and acronym:
  An Analysis of Real-World Data on the Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Both rheumatoid arthritis (RA) and older age are associated with a higher risk of comorbidities, and the appropriate treatment approach for older patients is unclear. We evaluated real-world data (RWD) to determine whether there is an association between etanercept (ETN) and select adverse events (AEs) in patients with RA, stratified by age. We hypothesized that there is no difference in risk of AEs between younger (aged ≤65 yr) and older (aged >65 yr) patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Truven MarketScan

Study timelines

Date when funding contract was signed

Actual:01/09/2012

Study start date

Actual:26/03/2018

Date of final study report

Actual:05/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

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