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Recruiting NCT07049653

Anifrolumab Pregnancy Study

— Observational Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 130 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab

Overview

This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.

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.

Primary outcome measures

  • Risk of major congenital malformations (MCM) [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Relative risk of MCM [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Risk of select pregnancy loss outcomes [Time frame: At delivery/birth]
  • Relative risk of select pregnancy loss outcomes [Time frame: At delivery/birth]
Secondary outcome measures (7)
  • Demographic and clinical characteristics [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Risk of minor congenital malformations (mCM) [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Relative risk of mCM [Time frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
  • Risk of adverse pregnancy outcomes [Time frame: At delivery/birth]
  • Relative risk of adverse pregnancy outcomes [Time frame: At delivery/birth]
  • Risk of adverse birth outcomes [Time frame: At delivery/birth]
  • Relative risk of adverse birth outcomes [Time frame: At delivery/birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Research Site — Cary

Identifiers

NCT: NCT07049653 · D3461R00028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗