The Anifrolumab PRIM Program

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Anifrolumab

• Registration Number: NCT06795893
• Lead Sponsor: AstraZeneca

Brief Summary

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Detailed Description

The anifrolumab PRIM program is a supplementary program which utilizes enhanced collection of secondary data from reported anifrolumab-exposed pregnancies collected as part of AstraZeneca's PV system.

Initial information about the exposed pregnancy will be collected through the pregnancy report submitted by anifrolumab treated patients or HCPs to the AstraZeneca PV database. Pregnancy outcome information will be collected in close proximity to the planned delivery. Additional follow-up and outcome information will be collected 12 months after delivery. For PV reports of exposed pregnancies that have already had a pregnancy outcome at the time of initial report (retrospective cases), initial characteristics, pregnancy outcome, and any available infant health information will be collected at the time of the initial report.

Targeted follow-up checklists and guidance documents will ensure that PV data collected for anifrolumab-exposed pregnancies are as complete as possible and have been mapped for pre-specified analytic variables that will be used to evaluate the safety of anifrolumab exposure for pregnancy and infant outcomes.

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Study Start: 2025-05-30
• Primary Completion: 2031-04-15
• Study Completion: 2031-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Currently or recently (within 1 year of pregnancy outcome) pregnant
• Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception

Exclusion Criteria

• Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anifrolumab exposed pregnancies	Anifrolumab	The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.

Primary Outcome Measures

Name	Time	Method
Major congenital malfunctions	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births	The primary objective of the PRIM program is to estimate the proportion of anifrolumab-exposed pregnancies with major congenital malformations (MCMs) associated with exposure to anifrolumab during pregnancy.

Secondary Outcome Measures

Name	Time	Method
Minor congenital malformations	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births	To estimate the proportion of anifrolumab-exposed pregnancies with minor congenital malformations associated with exposure to anifrolumab during pregnancy.
Adverse pregnancy outcomes	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births	To estimate the proportion of anifrolumab-exposed pregnancies with adverse pregnancy outcomes and adverse birth outcomes associated with exposure to anifrolumab during pregnancy.
Frequency of adverse pregnancy and birth outcomes	From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births	To estimate the frequency of adverse pregnancy and birth outcomes associated with exposure to anifrolumab during pregnancy and adverse effects on immune system development in infants with follow-up of up to one year of age.