Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT07049653
Recruiting Observational

Anifrolumab Pregnancy Study

NCT07049653 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2026-06-04
Last updated
2026-09-18

Condition(s) studied

Systemic Lupus Erythematosus

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Risk of major congenital malformations (MCM) — From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
    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
  • Relative risk of MCM — From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births
    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
  • Risk of select pregnancy loss outcomes — At delivery/birth
    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
  • Relative risk of select pregnancy loss outcomes — At delivery/birth
    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

Trial sites (1)

FacilityCityRegionStatus
Research Site Cary North Carolina Recruiting

More AstraZeneca trials in the USA

A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients. Recruiting
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer Recruiting
A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors Recruiting
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations Active, not recruiting
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144 Starting soon

Other trials for the same condition

US Zamto-cel Autoimmune Diseases Recruiting
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases Active, not recruiting
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE) Recruiting
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA) Recruiting
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07049653 on ClinicalTrials.gov ↗ ← All trials in the USA