A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health

Study acronym: A-MORE
StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to May 4, 2026
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Site details revised at 4 of 53 sites
    • Eligibility criteria expanded, about 5 words
  2. Minor Primary and study completion dates: Jun 2026 to Jul 2026v17
  3. Minor Primary and study completion dates: Apr 2026 to Jun 2026v16
  4. Minor Study sites: 52 to 53v15
  5. Minor Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Primary and study completion dates: Dec 2025 to Apr 2026v13
  2. Minor Enrollment target: 432 to 427v12
  3. Minor Enrollment target: 400 to 432v11
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 54 to 52
    v10
  5. Minor Enrollment target: 300 to 400
    • Study sites: 55 to 54
    v9
  6. Minor Study description expanded, about 138 words
    • Site details revised at 7 of 55 sites
    v8
  7. Minor Primary and study completion dates: Sep 2026 to Dec 2025
    • Site details revised at 27 of 55 sites
    v7
  8. Minor Study sites: 56 to 55v6
  9. Minor Study sites: 92 to 56v5
  10. Minor Study sites: 95 to 92v4
  11. Notable Primary and study completion dates: Sep 2025 to Sep 2026
    • Study sites: 88 to 95
    v3
  12. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 88
    • Start date changed from estimate of Mar 2020 to Mar 30, 2020
    v2
  1. Minor Study First Submitted
  • 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.
This is a 48-month observational, prospective, multicentre study. The overall aim of the study is to evaluate the long-term effectiveness of Elocta treatment on joint health in patients treated prophylactically with Elocta in a real-world setting.
Trial Details
NCT Number NCT04293523
Lead Sponsor Swedish Orphan Biovitrum
Conditions
(from sponsor)
Hemophilia A
Related terms Hemophilia A
Enrollment 427 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov