NCT06795893Recruiting
The Anifrolumab PRIM Program
Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 7 Nov 2025
- Primary completion date
- 15 Apr 2031
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT06795893
What you commit to
- Study type: Observational
- Planned participants: 240
- From 7 Nov 2025 to the primary completion date, 15 Apr 2031
- 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
- 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.
Who the study is looking for
- 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
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 |
|---|---|---|---|
| Reseach Facility Coordinator of this site? Confirm its status | Södertälje | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.