Anifrolumab Pregnancy Study

NCT07049653 | Not Yet Recruiting

• 1 other identifier: D3461R00028
• Study Type: observational
• Target: 627
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

pregnancy, anifrolumab, SLE

Outcome Measures

Primary Outcomes (4)

• Risk of major congenital malformations (MCM)

  Describe and estimate the risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

• Relative risk of MCM

  Estimate the relative risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy

  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

  Describe and estimate the risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

  At delivery/birth

• Relative risk of select pregnancy loss outcomes

  Estimate the relative risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy

  At delivery/birth

Secondary Outcomes (7)

• Demographic and clinical characteristics

  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)

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

• Relative risk of mCM

  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

  At delivery/birth

• Relative risk of adverse pregnancy outcomes

  At delivery/birth

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will encompass women with SLE of child-bearing potential age (15-49 years old) who start anifrolumab or other selected SLE treatments. For the safety outcomes analyses the study population will include pregnant women and their infant born anytime during the study period.

You may qualify if:

• 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

You may not qualify if:

• \- Pregnancies whose date of conception cannot be established
• 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
• Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
• Pregnancies whose date of conception cannot be established
• \- Women with moderate/severe SLE
• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Iqvia Pty Ltd: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: July 3, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 10, 2030
• Study Completion (Estimated): December 10, 2030
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.