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NCT06659029 | NOT YET RECRUITING | Systemic Lupus Erythematosus

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
Sponsor:

AstraZeneca

Brief Summary:

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.

Condition or disease

Systemic Lupus Erythematosus

Intervention/treatment

Anifrolumab

Detailed Description:

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a US-based, prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. The objective of the pregnancy registry is to compare adverse maternal, fetal, and infant outcomes of pregnant individuals with systemic lupus erythematosus (SLE) who are exposed to anifrolumab during pregnancy with outcomes in an internal comparison cohort of pregnant individuals with moderate/severe SLE who are not exposed to anifrolumab during pregnancy. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. The study is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during medical care will be actively collected. No additional laboratory tests or HCP assessments will be required as part of this registry. This study will fulfil an FDA post-marketing requirement.

Study Type : OBSERVATIONAL
Estimated Enrollment : 442 participants
Official Title : PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
Actual Study Start Date : 2024-11-29
Estimated Primary Completion Date : 2031-04-15
Estimated Study Completion Date : 2031-04-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Exposed cohort
  • 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
  • Unexposed cohort
  • 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
Exclusion Criteria
  • Exposed cohort
  • 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
  • Unexposed cohort
  • 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
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

Location Details

NCT06659029

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