Big data analysis on treatment patterns and safety events in patients identified as rheumatoid arthritis according to International Statistical Classification of diseases and Related Health Problems (RA SE)

Study identification

• EU PAS number:
  EUPAS35782
• Study ID:
  38440
• Official title and acronym:
  Big data analysis on treatment patterns and safety events in patients identified as rheumatoid arthritis according to International Statistical Classification of diseases and Related Health Problems (RA SE)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  RA SE study (Protocol #A3921283) is a non-interventional, retrospective cohort study, using Health insurance claim data that exist in anonymized structured format by the time of study start. The objectives of this study are to identify the treatment patterns and safety events in patients identified as rheumatoid arthritis by using the representative secondary data in Korea. This study has been conducted up to the final results as a local non-PASS study without taking over the final confirmation for the study scope as a non-PASS since 05-Aug-2017. However, as opening Quality Event (T1 PR ID: 2163843), this study is following the procedure for PASS.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:09/09/2017

Study start date

Actual:01/11/2017

Data analysis start date

Actual:10/05/2019

Date of final study report

Planned:31/10/2020

Actual:07/12/2020

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