Clinical trial NCT06659029: Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Official title: PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: Chronic autoimmune disease
Immunosuppressants
Corticosteroids
Human monoclonal antibody (IgG1ƙ mAb)
Post Marketing Requirements (PMR) study
Pregnancy
Systemic Lupus Erythematosus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2024-10-26
Enrollment: 442
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include 2 cohorts of pregnant individuals: a cohort of individuals with 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.

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 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.

Eligibility criteria: Inclusion Criteria:

Exposed cohort

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

Primary outcomes:
measure: Composite outcome of all major congenital malformations (MCMs)
timeFrame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
Secondary outcomes:
measure: Composite outcome of all minor congenital malformations
timeFrame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
measure: Worsening of underlying disease
timeFrame: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy
measure: Premature rupture of membranes
timeFrame: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy
measure: Pregnancy-induced hypertension
timeFrame: From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy
measure: Composite outcome of preeclampsia/eclampsia
timeFrame: From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy
measure: Maternal hospitalization for serious illness
timeFrame: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy
measure: Spontaneous abortion
timeFrame: From date of conception (DOC) to <20 gestational weeks
measure: Elective termination
timeFrame: From date of conception (DOC) to pregnancy outcome, up to 24 weeks of pregnancy
measure: Emergency caesarean section
timeFrame: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy
measure: Preterm birth
timeFrame: From date of conception (DOC) up to 37 gestational weeks
measure: Small for gestational age
timeFrame: At delivery of live birth
measure: Postnatal growth deficiency
timeFrame: At 4 and 12 months of infant age
measure: Infant developmental delay
timeFrame: At 4 and 12 months of infant age
measure: Infant hospitalization for serious illness
timeFrame: From birth to 1 year of infant age
measure: Infant serious or opportunistic infection
timeFrame: From birth to 1 year of infant age
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
Study officials:
References: