Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
627 participants
OBSERVATIONAL
2026-01-31
2030-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Exposed cohort
Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 with moderate/severe SLE
Exclusion Criteria
* Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
* Pregnancies whose date of conception cannot be established
* 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
18 Years
130 Years
FEMALE
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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D3461R00028
Identifier Type: -
Identifier Source: org_study_id
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