NCT06795893

The Anifrolumab PRIM Program

Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Anifrolumab	Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor,which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index,compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022,respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Timeline

• Start date: 2025-11-07
• Primary completion: 2031-04-15
• Completion: 2031-04-15
• First posted: 2025-01-28
• Last updated: 2026-03-19

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated drug study