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
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 design
Treatments tested in this trial
- Anifrolumab
Treatment groups
442 Participants
are divided into 2 treatment groupsSponsors and collaborators
AstraZeneca
Lead sponsor
PPD Development, LP
Collaborator
Source ClinicalTrials.gov