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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/108094
• 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:
  Ongoing

Research institution 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

Date of final study report

Planned: 30/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original apremilast 20210218 .pdf

Regulatory

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