Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Recruiting · NCT06659029 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Exposed cohort
- 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
Where it is running
1 location listed across 1 US state.
- Research Site - Wilmington, North Carolina, United States