The Anifrolumab PRIM Program

AstraZeneca

Status: Enrolling

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Anifrolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06795893

D3461R00090

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 1 patient group

Anifrolumab exposed pregnancies

Description:

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.

Treatment:

Drug: Anifrolumab