NCT06659029 Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
| NCT ID | NCT06659029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 442 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2031-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 442 participants in total. It began in 2025-07-01 with a primary completion date of 2031-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06659029 clinical trial?
This trial is open to female participants only, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06659029 currently recruiting?
Yes, NCT06659029 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06659029 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT06659029 clinical trial?
NCT06659029 is sponsored by AstraZeneca. The trial plans to enroll 442 participants.
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