Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users - PRIMULA_Preg

Study identifier:D3461R00051

ClinicalTrials.gov identifier:NCT06659029

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 4

Healthy volunteers

Study drug

Anifrolumab

Sex

Female

Estimated Enrollment

442

Study type

Observational

Age

n/a - n/a

Date

Study Start Date: 31 Mar 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

Collaborators

PPD

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Exposed cohort Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy	Drug: Anifrolumab Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group–based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index, compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy. Other Name: Saphnelo
Unexposed cohort Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE	-

Arms

Assigned Interventions

Exposed cohort
Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy

Drug: Anifrolumab
Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group–based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index, compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Other Name: Saphnelo

Unexposed cohort
Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Kat Downes

PPD, Miami, US