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NCT06659029 · ClinicalTrials.gov registry record
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
A clinical trial of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
- Recruiting
- Registry status
- 442
- Enrollment target
- 1
- Study location
NCT06659029 is a study of Systemic Lupus Erythematosus that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 442 participants, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06659029, a study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- 442 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Anifrolumab
Study Locations (1)
North Carolina
- Research Site - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2031-04-15 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06659029
The ClinicalTrials.gov registry entry for NCT06659029 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 442 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (18% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Anifrolumab is the first listed.
NCT06659029 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06659029 about?
NCT06659029 is a clinical study titled "Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users". 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 ...
What is the current status of trial NCT06659029?
This trial is currently recruiting. The enrollment target is 442 participants. The study started on 2025-07-01. Estimated completion is 2031-04-15.
What conditions does trial NCT06659029 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT06659029?
The interventions under investigation include: Anifrolumab (DRUG).
Who is sponsoring clinical trial NCT06659029?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06659029 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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