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Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: Anifrolumab

Countries: United States

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 overview

Sex: FEMALE

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (1)

Wilmington, North Carolina, United States