The Anifrolumab PRIM Program

Sponsor
AstraZeneca
Study ID
NCT06795893
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anifrolumab — DRUG
    Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor,which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index,compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022,respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Study Details

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Key Dates

First listed
Jan 28, 2025
Start date
Nov 7, 2025
Status verified
Jul 2026
Primary completion
Apr 15, 2031
Completion
Apr 15, 2031

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Anifrolumab exposed pregnancies
    The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.

Primary Outcome Measure

Major congenital malfunctions [ Time Frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births ]

Central Contacts

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