Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

NCT ID: NCT06659029

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 442 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2031-04-15

Brief Summary

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.

Detailed Description

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a US-based, prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. The objective of the pregnancy registry is to compare adverse maternal, fetal, and infant outcomes of pregnant individuals with moderate/severe systemic lupus erythematosus (SLE) who are exposed to anifrolumab during pregnancy with outcomes in an internal comparison cohort of pregnant individuals with moderate/severe SLE who are not exposed to anifrolumab during pregnancy. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. The study is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during medical care will be actively collected. No additional laboratory tests or HCP assessments will be required as part of this registry. This study will fulfil an FDA post-marketing requirement.

Conditions

Systemic Lupus Erythematosus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed cohort

Pregnant individuals with a diagnosis of moderate/severe SLE who are exposed to anifrolumab at any time during pregnancy

Anifrolumab

Intervention Type: DRUG

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.

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

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Saphnelo

Eligibility Criteria

Inclusion Criteria

Exposed cohort

1. Currently or recently (within 1 year of pregnancy outcome) pregnant

2. Diagnosis of moderate/severe SLE

3. Consent to participate

4. Authorization for their HCP(s) to provide data to the registry

5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy

Unexposed cohort

1. Currently or recently pregnant

2. Diagnosis of moderate/severe SLE

3. Consent to participate

4. Authorization for their HCP(s) to provide data to the registry

5. Exposure to other products for the treatment of moderate/severe SLE

Exclusion Criteria

Exposed cohort

1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)

2. Exposure to known teratogens and/or investigational medications during pregnancy

Unexposed cohort

1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)

2. Exposure to known teratogens and/or investigational medications during pregnancy

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Wilmington, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

AstraZeneca Clinical Study Information Center

Role: CONTACT

information.center@astrazeneca.com

1-877-240-9479

Other Identifiers

D3461R00051

Identifier Type: -

Identifier Source: org_study_id