Monitoring pregnancy and infant outcomes after anifrolumab exposure
Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program
This program collects health information to see if exposure to the lupus medicine anifrolumab affects pregnant people or their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Sex | Female |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | anifrolumab |
| Locations | 1 site (Södertälje) |
| Trial ID | NCT06795893 on ClinicalTrials.gov |
What this trial studies
The PRIM program is a supplemental pharmacovigilance effort that gathers enhanced secondary data on pregnancies exposed to anifrolumab reported to AstraZeneca's safety database. Initial pregnancy reports are captured from patients or healthcare providers and are followed up near delivery and again at 12 months postpartum to collect infant outcomes. Retrospective reports with completed outcomes are also included, and data are mapped to pre-specified analytic variables using targeted follow-up checklists and guidance. Cases already enrolled in the prospective pregnancy registry or involving known teratogens or investigational drugs are excluded.
Who should consider this trial
Good fit: People who are currently pregnant or recently pregnant (outcome within the past year) who received at least one dose of anifrolumab during pregnancy or within 16 weeks before conception and who are not enrolled in the prospective pregnancy registry are ideal candidates.
Not a fit: People who were not exposed to anifrolumab, who were exposed to known teratogens or investigational medications, or who were already enrolled in the separate prospective pregnancy registry will not benefit from inclusion in this program.
Why it matters
Potential benefit: If successful, this program could improve understanding of anifrolumab safety in pregnancy and help inform treatment decisions for people with lupus.
How similar studies have performed: Pregnancy registries and post-marketing surveillance programs for biologic therapies have previously provided useful safety signals, but data specifically for anifrolumab are limited and this program supplements an existing prospective registry.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Södertälje
- Reseach Facility — Södertälje, Sweden (Recruiting)
Study contacts
- Principal investigator: Syd Philips — PPD Miami, US
- 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.