Anifrolumab Pregnancy Study
Key facts
- Where
- Cary, Egyesült ÁllamokSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 130 years old?
Forrás: NCT07049653: ki vehet részt
Where in Egyesült Államok
- CaryCary, Egyesült ÁllamokTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07049653
- Record updated
- 2026. szeptember 18.
- Original description
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.Read full original descriptionShow less
A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Inclusion: 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; 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; Women with moderate/severe SLE.
Exclusion: Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2; Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy; Women with a history of CM or chromosomal abnormalities (according to available records), before delivery; Pregnancies whose date of conception cannot be established; Pregnancies whose date of conception cannot be established.