A Retrospective Cohort Study Using Health Administrative Claims Databases to Assess Adverse Pregnancy and Infant Outcomes in Women with Psoriasis Who Were Exposed to Guselkumab Versus Other Biologic Therapies During Pregnancy. PASS-EMA

Study identification

• EU PAS number:
  EUPAS30740
• Study ID:
  103402
• Official title and acronym:
  A Retrospective Cohort Study Using Health Administrative Claims Databases to Assess Adverse Pregnancy and Infant Outcomes in Women with Psoriasis Who Were Exposed to Guselkumab Versus Other Biologic Therapies During Pregnancy. PASS-EMA
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  TREMFYA (guselkumab) pregnancy healthcare database study. PASS-EMA
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 13/07/2017

Study start date

Actual: 14/07/2017

Data analysis start date

Planned: 31/12/2022

Actual: 01/02/2023

Date of final study report

Planned: 30/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen R&D

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)