Characterizing Otezla Use and Exposure Among Pregnant Women (20220012)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50662
• EU PAS number:
  EUPAS46267
• Study ID:
  50662
• Official title and acronym:
  Characterizing Otezla Use and Exposure Among Pregnant Women (20220012)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 31/01/2022

Actual: 31/01/2022

Study start date

Planned: 30/03/2022

Actual: 30/03/2022

Data analysis start date

Planned: 30/03/2022

Actual: 30/03/2022

Date of final study report

Planned: 30/09/2022

Actual: 14/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Observational Research Study Report 20220012 new_Redacted

Regulatory

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