Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Description

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.

Conditions

Systemic Lupus Erythematosus

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Study Overview

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Study Details

Study overview

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.

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Las Vegas

Research Site, Las Vegas, Nevada, United States, 89113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Currently or recently (within 1 year of pregnancy outcome) pregnant
  • 2. Diagnosis of SLE
  • 3. Consent to participate
  • 4. Authorization for their HCP(s) to provide data to the registry
  • 5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy
  • 1. Currently or recently pregnant
  • 2. Diagnosis of moderate/severe SLE
  • 3. Consent to participate
  • 4. Authorization for their HCP(s) to provide data to the registry
  • 5. Exposure to other products for the treatment of moderate/severe SLE
  • 1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)
  • 2. Exposure to known teratogens and/or investigational medications during pregnancy
  • 1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)
  • 2. Exposure to known teratogens and/or investigational medications during pregnancy

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Kat Downes, PhD, MPH, PRINCIPAL_INVESTIGATOR, PPD, Miami, US

Study Record Dates

2031-04-15