| NCT ID | NCT06795893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2031-04-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
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.
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