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Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Study acronym: PRIMULA Lac
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 19 words Secondary endpoints: details revised at 3 of 5 entries · Study description revised Show 2 more changesShow less
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description revised
  2. 2 versions Re-verified since Jul 20, 2026, no change to tracked fieldsv21-v22
  3. Eligibility criteria expanded, about 10 words Study description expanded, about 148 wordsv20 Show 1 more changeShow less
    • Study description expanded, about 148 words

    See this version in full on ClinicalTrials.gov ↗

  4. 3 versions Re-verified since Mar 3, 2026, no change to tracked fieldsv17-v19
  5. Start date changed from estimate of Jan 30, 2026 to Jan 16, 2026v16
Show 14 earlier versionsHide 14 earlier versions
  1. 3 versions Re-verified since Nov 26, 2025, no change to tracked fieldsv13-v15
  2. Start date: Oct 31, 2025 to Jan 30, 2026v12
  3. Re-verified, no change to tracked fieldsv11
  4. Start date: Aug 29, 2025 to Oct 31, 2025v10
  5. 2 versions Re-verified since Jun 24, 2025, no change to tracked fieldsv8-v9
  6. Start date: May 30, 2025 to Aug 29, 2025v7
  7. Start date: Feb 28, 2025 to May 30, 2025v6
  8. Re-verified, no change to tracked fieldsv5
  9. Start date: Nov 29, 2024 to Feb 28, 2025v4
  10. Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  11. Study sites: 0 to 1v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 61 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.
Trial Details
NCT Number NCT06594068
Lead Sponsor AstraZeneca
Collaborators: PPD Development, LP
Conditions Systemic Lupus Erythematosus
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov