The Anifrolumab PRIM Program

Launched by ASTRAZENECA · Jan 22, 2025

Keywords

ClinConnect Summary

The Anifrolumab PRIM Program is a clinical trial that aims to understand the effects of a medication called anifrolumab on pregnancy and infant outcomes in women with a condition known as systemic lupus erythematosus (SLE). This study is specifically looking at women who are currently pregnant or who have recently been pregnant and have taken at least one dose of anifrolumab during their pregnancy or in the 16 weeks before they became pregnant.

To join this trial, women must be pregnant or have had a pregnancy outcome within the past year and must have used anifrolumab. However, women who have already participated in another pregnancy registry study or who have been exposed to certain harmful medications will not be eligible. Participants in this study will provide information about their pregnancy and baby, which will help researchers learn more about how anifrolumab affects both mothers and infants. It's important to note that this trial is not yet recruiting participants, so it will start accepting volunteers in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Currently or recently (within 1 year of pregnancy outcome) pregnant
• • Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception
• Exclusion Criteria:
• • Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.