The anifrolumab PRIM program - PRIM

Study identifier:D3461R00090

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Medical condition

Systemic Lupus Erythematosus

Phase

N/A

Healthy volunteers

No

Study drug

Anifrolumab

Sex

Female

Estimated Enrollment

240

Study type

Observational

Age

n/a - n/a

Date

Study Start Date: 28 Feb 2025
Estimated Primary Completion Date: 15 Apr 2031
Estimated Study Completion Date: 15 Apr 2031

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jan 2025 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PPD

Inclusion and exclusion criteria