Observational Cohort Study of Ritlecitinib Safety in Pregnancy within a US Claims Database

Study identification

• EU PAS number:
  EUPAS1000000553
• Study ID:
  1000000553
• Official title and acronym:
  Observational Cohort Study of Ritlecitinib Safety in Pregnancy within a US Claims Database
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to assess the safety of ritlecitinib when used in pregnancy in terms of risk of major congenital malformations (MCMs), spontaneous abortion, pregnancy termination, stillbirth, pregnancy-related hypertension, gestational diabetes, pre-eclampsia, eclampsia, small for gestational age (SGA) births, preterm birth, and serious infection in the first year of life. ; This non-interventional study (NIS) is designated as a PASS and is a postmarketing requirement for the FDA.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Carelon Research
Optum USA

Study timelines

Date when funding contract was signed

Planned: 18/08/2023

Actual: 18/08/2023

Study start date

Planned: 01/03/2029

Date of interim report, if expected

Planned: 28/02/2030

Date of final study report

Planned: 30/06/2035

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

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

Other study registration identification numbers and links

B7981096