Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users - PRIMULA Lac

Study identifier:D3461R00052

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 4

Healthy volunteers

No

Study drug

Anifrolumab

Sex

Female

Estimated Enrollment

16

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Nov 2024
Estimated Primary Completion Date: 31 Aug 2027
Estimated Study Completion Date: 31 Aug 2027

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PPD

Inclusion and exclusion criteria