Anifrolumab Pregnancy Study
Purpose
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Condition
- Systemic Lupus Erythematosus
Eligibility
- Eligible Ages
- Between 18 Years and 130 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Exposed cohort | Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy | |
| Unexposed cohort | Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE |
Recruiting Locations
Cary, North Carolina 27513
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.