An Observational Cohort Study to Investigate the Risk of Serious Infections Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV) Database in Japan (4V-JE-B019)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48505
• EU PAS number:
  EUPAS48504
• Study ID:
  48505
• Official title and acronym:
  An Observational Cohort Study to Investigate the Risk of Serious Infections Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV) Database in Japan (4V-JE-B019)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective of this study is to assess and compare the risk of SIs in the patients exposed to baricitinib with those in the patients with RA who newly started any bDMARD. The secondary objectives of the study are: * To describe incidence of SIs in elderly patients (aged ≥65 years). * To describe the incidence rates of herpes zoster.
• Study status:
  Ongoing

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 17/12/2020

Actual: 17/12/2020

Study start date

Planned: 01/04/2008

Actual: 25/05/2021

Date of final study report

Planned: 30/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly Japan K.K.

Regulatory

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