An Observational Study to Describe Women Exposed to Apremilast During Pregnancy and Infant Outcomes During the First Year of Life (20210218)

Study identification

• EU PAS number:
  EUPAS107685
• Study ID:
  108094
• Official title and acronym:
  An Observational Study to Describe Women Exposed to Apremilast During Pregnancy and Infant Outcomes During the First Year of Life (20210218)
• 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:16/11/2023

Actual:30/08/2023

Study start date

Planned:15/12/2023

Actual:15/12/2023

Data analysis start date

Planned:01/10/2024

Actual:01/10/2024

Date of final study report

Planned:30/06/2025

Actual:08/05/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

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