Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tracks pregnancy and baby health in people with moderate or severe lupus, a disease in which the body's defenses attack healthy tissue. It looks at whether anifrolumab use during pregnancy is linked to health problems, compared with other lupus treatments.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have moderate or severe lupus, also called SLE.
- For the anifrolumab group: be pregnant now or have had a pregnancy end within the past year.
- For the anifrolumab group: have received at least 1 dose of anifrolumab during pregnancy.
- For the other treatment group: be pregnant now or have recently been pregnant.
- For the other treatment group: have used other medicines to treat moderate or severe lupus.
- Agree to take part in the study.
- Allow your health care providers to share your health information with the study.
Who can't join
- Your pregnancy ended before your first contact with the study's Virtual Research Coordination Center to enroll.
- During pregnancy, you were exposed to a substance known to cause birth defects or used a medicine still being tested.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Exposed cohort 1. Currently or recently (within 1 year of pregnancy outcome) 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 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
Study sites (1)
NC
- Research Site · Wilmington, NC 28401More trials in Wilmington