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Anifrolumab Pregnancy Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 130 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Adverse outcomes related to infant growth up to one year of age will also be investigated."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses health databases to learn about the safety of anifrolumab during pregnancy. It compares women with moderate or severe lupus (SLE) who took anifrolumab with women who received usual lupus care without it.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were diagnosed with lupus before pregnancy. Lupus is a disease in which the immune system attacks the body.
  • Your lupus is moderate or severe.
  • You were in the health database without a break for at least 12 months before your last menstrual period.
  • For the anifrolumab group: You took anifrolumab along with usual lupus treatment during pregnancy or in the 16 weeks before your last menstrual period.
  • For the comparison group: You received usual lupus treatment during pregnancy.

Who can't join

  • The date your pregnancy began cannot be worked out.
  • Available records show a history of birth defects or chromosome problems before delivery. Chromosomes carry genetic information.
  • You were prescribed a drug known to cause birth defects during pregnancy or within a set time before your last menstrual period. This time is five drug half-lives—the time needed for most of the drug to leave the body.
  • For the comparison group only: You took anifrolumab during pregnancy or in the 16 weeks before your last menstrual period.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC