Anifrolumab Pregnancy Study
Recruiting · NCT07049653 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →What this trial is about
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Who can take part
Age range
18 Years to 130 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- for EXPOSED SOURCE POPULATION:
- Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- Women diagnosed with SLE before pregnancy
- Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2
Exclusion criteria
- for EXPOSED SOURCE POPULATION:
- \- Pregnancies whose date of conception cannot be established
- Inclusion criteria for UNEXPOSED SOURCE POPULATION:
- Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
- Women diagnosed with SLE before pregnancy
- Women treated with SLE SOC during pregnancy
- Exclusion criteria for UNEXPOSED SOURCE POPULATION:
- Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
- Pregnancies whose date of conception cannot be established
- Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- \- Women with moderate/severe SLE
- Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
- Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
- Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy
Where it is running
1 location listed across 1 US state.
- Research Site - Cary, North Carolina, United States