Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
AstraZeneca
Study ID
NCT06659029
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

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.

Key Dates

Start date
Jul 1, 2025
Status verified
May 2026
Primary completion
Apr 15, 2031
Completion
Apr 15, 2031

Study Design

Enrollment
442 participants (estimated)

Arms

  • Arm: Exposed cohort
    Pregnant individuals with a diagnosis of moderate/severe SLE who are exposed to anifrolumab at any time during pregnancy
  • Arm: 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

Primary Outcome Measure

Composite outcome of all major congenital malformations (MCMs) [ Time Frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteWilmingtonNorth Carolina28401-

Find similar trials in Wilmington, NC

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Research Site· Wilmington, NC

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