Anifrolumab Pregnancy Study in women with lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional, multi-database post-authorisation study designed to describe congenital malformations, adverse pregnancy outcomes, and birth outcomes in pregnancies exposed to anifrolumab. It will compare these outcomes with pregnancies in women with SLE who received standard of care but not anifrolumab, and will also examine infant growth up to one year of age. The analysis relies on real-world data from observational sources to characterize safety signals in this patient group. The study includes women with continuous database enrollment, a diagnosis of SLE before pregnancy, and exposure to anifrolumab during pregnancy or in the 16 weeks prior to the last menstrual period, as well as a comparator group not exposed to the drug.

Why it matters

Who can join: the full rules

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's running

• Research Site
  Cary, North Carolina, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Monitoring pregnancy and infant outcomes after anifrolumab exposure

  This program collects health information to see if exposure to the lupus medicine anifrolumab affects pregnant people or their babies.

  Recruiting AstraZeneca · Södertälje · NCT06795893

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.