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Recruiting NCT06795893

The Anifrolumab PRIM Program

— Observational Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anifrolumab.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 placeb

Primary outcome measures

  • Major congenital malfunctions [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
Secondary outcome measures (3)
  • Minor congenital malformations [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Adverse pregnancy outcomes [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Frequency of adverse pregnancy and birth outcomes [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Sweden · 1 center
  • Reseach Facility — Södertälje

Identifiers

NCT: NCT06795893 · D3461R00090

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗