Registry to investigate maternal and infant outcomes in users of anifrolumab during pregnancy
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
This study is looking to see how using the drug anifrolumab during pregnancy affects mothers and their babies, specifically for those with systemic lupus erythematosus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 442 (estimated) |
| Sex | Female |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | anifrolumab |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT06659029 on ClinicalTrials.gov |
What this trial studies
PRIMULA Preg is a prospective, observational cohort study aimed at evaluating the effects of anifrolumab exposure during pregnancy on maternal, fetal, and infant outcomes. The study compares outcomes in pregnant individuals with systemic lupus erythematosus (SLE) who have been exposed to anifrolumab to those who have not. Participation is voluntary, and data will be collected from medical records without requiring additional tests or assessments. This registry is part of an FDA post-marketing requirement.
Who should consider this trial
Good fit: Ideal candidates include currently or recently pregnant individuals diagnosed with systemic lupus erythematosus who have either been exposed to anifrolumab or other treatments for moderate/severe SLE.
Not a fit: Patients who have experienced pregnancy outcomes prior to enrollment or those exposed to known teratogens during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of anifrolumab for pregnant individuals with SLE and inform treatment decisions.
How similar studies have performed: While this study addresses a specific post-marketing requirement, similar observational studies have shown success in evaluating treatment safety during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Exposed cohort 1. Currently or recently (within 1 year of pregnancy outcome) pregnant 2. Diagnosis of moderate/severe SLE 3. Consent to participate 4. Authorization for their HCP(s) to provide data to the registry 5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy Unexposed cohort 1. Currently or recently pregnant 2. Diagnosis of moderate/severe SLE 3. Consent to participate 4. Authorization for their HCP(s) to provide data to the registry 5. Exposure to other products for the treatment of moderate/severe SLE Exclusion Criteria: Exposed cohort 1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled) 2. Exposure to known teratogens and/or investigational medications during pregnancy Unexposed cohort 1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled) 2. Exposure to known teratogens and/or investigational medications during pregnancy
Where this trial is running
Wilmington, North Carolina
- Research Site — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.