A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/199011
• EU PAS number:
  EUPAS108728
• Study ID:
  199011
• Official title and acronym:
  A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE PASS)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  France

  Germany

  United States
• Study description:
  The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other SOC but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 15/03/2022

Actual: 15/03/2022

Study start date

Planned: 31/05/2025

Date of final study report

Planned: 31/03/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

AZ SLE anifrolumab pregnancy PASS_Protocol v3.0_28Aug2023_redacted

Updated protocol

AZ SLE anifrolumab pregnancy PASS_Protocol_v5.0_17Oct2024_redacted

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)