Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Launched by ASTRAZENECA · Oct 23, 2024

Keywords

ClinConnect Summary

The PRIMULA Preg study is looking at how the medication anifrolumab affects pregnant women with systemic lupus erythematosus (SLE) and their babies. This study is important because it aims to understand any potential risks or problems that might arise for mothers and infants when anifrolumab is used during pregnancy. The research is part of a requirement from the FDA to ensure that the medication is safe for pregnant women and their children.

To participate in this study, women must be currently pregnant or have recently given birth, have a diagnosis of SLE, and must agree to share their health information with the research team. Some women will have taken anifrolumab during their pregnancy (the exposed group), while others will have used different treatments for SLE (the unexposed group). Participants can expect to provide information about their health and pregnancy outcomes, which will help researchers gather valuable data. It's important for potential participants to know that the study is focused on understanding maternal and infant health, and it aims to contribute to safer treatment options for pregnant women with SLE.

Gender

FEMALE

Eligibility 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