Monitoring pregnancy and infant outcomes after anifrolumab exposure

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

The PRIM program is a supplemental pharmacovigilance effort that gathers enhanced secondary data on pregnancies exposed to anifrolumab reported to AstraZeneca's safety database. Initial pregnancy reports are captured from patients or healthcare providers and are followed up near delivery and again at 12 months postpartum to collect infant outcomes. Retrospective reports with completed outcomes are also included, and data are mapped to pre-specified analytic variables using targeted follow-up checklists and guidance. Cases already enrolled in the prospective pregnancy registry or involving known teratogens or investigational drugs are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Reseach Facility
  Södertälje, Sweden Recruiting

Study contacts

• Principal investigator: Syd Philips — PPD Miami, US
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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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.