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The Anifrolumab PRIM Program

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: Anifrolumab

Countries: Sweden

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Eligibility overview

Sex: FEMALE

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (1)

Södertälje, Sweden