Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Recruiting now · Has a placebo group
Conditions studied: Systemic Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT06659029
- Run by
- AstraZeneca
- People needed
- 442
- Starts
- 2025-07-01
- Expected to finish
- 2031-04-15
- Last updated by the study team
- 2026-06-24
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Research Site — Wilmington, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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