Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. Relevant exposure window is limited to 1st trimester of pregnancy.
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 |
What NCT06659029 shows while recruiting
NCT06659029 is an observational study that tracks outcomes without assigning an intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, above the 376-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (18% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06659029's enrollment target sits among peer trials
442 19th of 99 higher than 81 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
RECRUITING · Phase 3
-
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
RECRUITING · Phase 1
-
A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus
RECRUITING · Phase 1
-
Creating Health Course Study for People With Rheumatological Conditions
RECRUITING · NA
-
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
RECRUITING
-
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704766 · 442 participants · NA
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
- NCT04657068 · 442 participants · Phase 1
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
- NCT05410145 · 442 participants · Phase 1
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
- NCT06780670 · 443 participants · Phase 2
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI