Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Sweden
Reseach Facility
RECRUITING
Södertälje
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-11-07
Estimated Completion Date: 2031-04-15
Participants
Target number of participants: 240
Treatments
Anifrolumab exposed pregnancies
The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: PPD Development, LP