Health TrialsbyHealthPanel

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

442 Participants
are divided into 2 treatment groups
Group A: Exposed cohort1 intervention
Group B: Unexposed cohort0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Composite outcome of all minor congenital malformations

An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual. Relevant exposure window includes any trimester of pregnancy.

Time frame
From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
2

Worsening of underlying disease

Any increase in disease activity or severity in the pregnancy period compared to the baseline period (6 months prior to pregnancy) as assessed by the disease flare or disease activity algorithms or as reported by an HCP. Relevant exposure window includes any trimester of pregnancy.

Time frame
From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy
3

Premature rupture of membranes

A disorder of pregnancy defined as rupture of membranes before the onset of labor. Relevant exposure window includes any trimester of pregnancy.

Time frame
From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy
4

Pregnancy-induced hypertension

A disorder of pregnancy defined as a systolic blood pressure 140 mmHg or more or a diastolic blood pressure of 90 mmHg or more, or both, on 2 occasions at least 4 hours apart after 20 weeks gestation, in a woman with a previously normal blood pressure. Relevant exposure window includes any trimester of pregnancy.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

PPD Development, LP

Collaborator

Source ClinicalTrials.gov
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