Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

NCT06659029 | Recruiting FDA Drug

• 1 other identifier: D3461R00051
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Chronic autoimmune disease; Immunosuppressants; Corticosteroids; Human monoclonal antibody (IgG1ƙ mAb); Post Marketing Requirements (PMR) study; Pregnancy; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Composite outcome of all major congenital malformations (MCMs)

  An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Relevant exposure window is limited to 1st trimester of pregnancy.

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Secondary Outcomes (15)

• Composite outcome of all minor congenital malformations

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

• Worsening of underlying disease

  From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy

• Premature rupture of membranes

  From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy

• Pregnancy-induced hypertension

  From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy

• Composite outcome of preeclampsia/eclampsia

  From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy

Study Arms (2)

Exposed cohort

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

Drug: Anifrolumab

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

Interventions

Anifrolumab 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.

Also known as: Saphnelo

Exposed cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include 2 cohorts of pregnant individuals: a cohort of individuals with moderate/severe SLE who are exposed to anifrolumab and a cohort of individuals with moderate/severe SLE who are unexposed to anifrolumab but who are exposed to other products for the treatment of SLE.

You may qualify if:

• Exposed cohort
• Currently or recently (within 1 year of pregnancy outcome) pregnant
• Diagnosis of moderate/severe SLE
• Consent to participate
• Authorization for their HCP(s) to provide data to the registry
• Exposure to at least 1 dose of anifrolumab at any time during pregnancy
• Unexposed cohort
• Currently or recently pregnant
• Diagnosis of moderate/severe SLE
• Consent to participate
• Authorization for their HCP(s) to provide data to the registry
• Exposure to other products for the treatment of moderate/severe SLE

You may not qualify if:

• Exposed cohort
• Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)
• Exposure to known teratogens and/or investigational medications during pregnancy
• Unexposed cohort
• Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)
• Exposure to known teratogens and/or investigational medications during pregnancy

Sponsors & Collaborators

• AstraZeneca: lead
• PPD Development, LP: collaborator

Study Sites (1)

Research Site

Wilmington, North Carolina, 28401, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 26, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): April 15, 2031
• Study Completion (Estimated): April 15, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of IPD sharing timelines, please refer to AZ disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via a secure research environment Vivli.org. A signed data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)