The Anifrolumab PRIM Program
Recruiting · NCT06795893 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Reseach Facility - Södertälje, Sweden