NCT07049653Recruiting
Anifrolumab Pregnancy Study
A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 23 May 2025
- Start date
- 4 Jun 2026
- Primary completion date
- 10 Dec 2030
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT07049653
What you commit to
- Study type: Observational
- Planned participants: 500
- From 4 Jun 2026 to the primary completion date, 10 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
Other
- \- Pregnancies whose date of conception cannot be established
- Pregnancies whose date of conception cannot be established
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.