NCT06659029Recruiting
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 442 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 1 Jul 2025
- Primary completion date
- 15 Apr 2031
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT06659029
What you commit to
- Study type: Observational
- Planned participants: 442
- From 1 Jul 2025 to the primary completion date, 15 Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Exposed cohort
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.