RECRUITING

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-31
Study Completion:2031-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06659029

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Currently or recently (within 1 year of pregnancy outcome) pregnant
  2. 2. Diagnosis of SLE
  3. 3. Consent to participate
  4. 4. Authorization for their HCP(s) to provide data to the registry
  5. 5. Exposure to at least 1 dose of anifrolumab at any time during pregnancy
  6. 1. Currently or recently pregnant
  7. 2. Diagnosis of moderate/severe SLE
  8. 3. Consent to participate
  9. 4. Authorization for their HCP(s) to provide data to the registry
  10. 5. Exposure to other products for the treatment of moderate/severe SLE
  1. 1. Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)
  2. 2. Exposure to known teratogens and/or investigational medications during pregnancy
  3. 1. Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)
  4. 2. Exposure to known teratogens and/or investigational medications during pregnancy

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

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

Study Locations (Sites)

Research Site
Las Vegas, Nevada, 89113
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2031-04-15

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2031-04-15

Terms related to this study

Keywords Provided by Researchers

  • Chronic autoimmune disease
  • Immunosuppressants
  • Corticosteroids
  • Human monoclonal antibody (IgG1ƙ mAb)
  • Post Marketing Requirements (PMR) study
  • Pregnancy
  • Systemic Lupus Erythematosus

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus