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.
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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…
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
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