The Anifrolumab PRIM Program
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAstraZeneca
About this trial
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
Eligibility criteria
Qualifiers
Currently or recently (within 1 year of pregnancy outcome) pregnant
Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception
Disqualifiers
Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.
Trial design
Treatments tested in this trial
- Anifrolumab
Treatment groups
240 Participants
are divided into 1 treatment groupSponsors and collaborators
AstraZeneca
Lead sponsor
PPD Development, LP
Collaborator
Source ClinicalTrials.gov