Clinical trial NCT06795893: The Anifrolumab PRIM Program
Official title: Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: chronic autoimmune disease
immunosuppressants
corticosteroids
human monoclonal antibody (IgG1ƙ mAb)
post Marketing Requirements (PMR) study
pregnancy
Systemic Lupus Erythematosus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2025-01-28
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnancies exposed to anifrolumab and reported to the AstraZeneca pharmacovigilance database on or after the initiation of the PRIM program, regardless of when the pregnancy outcome was ascertained.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major congenital malfunctions
timeFrame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Secondary outcomes:
measure: Minor congenital malformations
timeFrame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
measure: Adverse pregnancy outcomes
timeFrame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
measure: Frequency of adverse pregnancy and birth outcomes
timeFrame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Other outcomes:
Locations:
Study officials:
affiliation: PPD Miami, US
name: Syd Philips
role: PRINCIPAL_INVESTIGATOR
References: