Follows pregnant people with lupus who take anifrolumab
Observes outcomes for mothers and babies after anifrolumab is taken during pregnancy.
Plain-language title generated from the registry record
Registry title: Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Key facts
- Where
- Wilmington, United StatesSee the site
Where in United States
- WilmingtonWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06659029
- Record updated
- 2 September 2026
- Original description
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.Read full original descriptionShow less
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.
Inclusion: Exposed cohort; Currently or recently (within 1 year of pregnancy outcome) pregnant; Diagnosis of moderate/severe SLE; Consent to participate; Authorization for their HCP(s) to provide data to the registry; Exposure to at least 1 dose of anifrolumab at any time during pregnancy; Unexposed cohort; Currently or recently pregnant; Diagnosis of moderate/severe SLE; Consent to participate; Authorization for their HCP(s) to provide data to the registry; Exposure to other products for the treatment of moderate/severe SLE.
Exclusion: Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled); Exposure to known teratogens and/or investigational medications during pregnancy; Unexposed cohort; Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled); Exposure to known teratogens and/or investigational medications during pregnancy; Exposed cohort.