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Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

Study acronym: BEAT-MS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Start date: Dec 19, 2019 to Aug 17, 2020 Study sites: 22 to 23 · Eligibility criteria expanded, about 25 words · Secondary endpoints: details revised at 7 of 12 entries Show 3 more changesShow less
    • Study sites: 22 to 23
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 7 of 12 entries
  2. Site contacts updated at 1 of 22 sitesv52
  3. Study sites: 20 to 22v51
  4. Site contacts updated at 2 of 20 sitesv50
  5. Study Identification, Study Statusv49
Show 45 earlier versionsHide 45 earlier versions
  1. Site contacts updated at 1 of 20 sitesv48
  2. Study sites: 19 to 20v47
  3. Site contacts updated at 1 of 19 sitesv46
  4. Site details revised at 1 of 19 sitesv45
  5. Site details revised at 1 of 19 sitesv44
  6. Site contacts updated at 1 of 19 sitesv43
  7. Study sites: 20 to 19v42
  8. Eligibility criteria expanded, about 40 wordsv41 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 21 to 20v40
  10. Study sites: 20 to 21v39
  11. Site details revised at 1 of 20 sitesv38
  12. Study sites: 21 to 20v37
  13. Site details revised at 1 of 21 sitesv36
  14. Study sites: 22 to 21v35
  15. Eligibility criteria expanded, about 48 wordsv34 See this version in full on ClinicalTrials.gov ↗
  16. Site contacts updated at 1 of 22 sitesv33
  17. Site details revised at 1 of 22 sitesv32
  18. Study sites: 21 to 22v31
  19. Site contacts updated at 1 of 21 sitesv30
  20. Site contacts updated at 1 of 21 sitesv29
  21. Site contacts updated at 1 of 21 sitesv28
  22. Site contacts updated at 1 of 21 sitesv27
  23. Re-verified, no change to tracked fieldsv26
  24. Study sites revised (21)v25 See this version in full on ClinicalTrials.gov ↗
  25. Site details revised at 3 of 21 sitesv24
  26. Site details revised at 1 of 21 sitesv23
  27. Site details revised at 2 of 21 sitesv22
  28. Site contacts updated at 1 of 21 sitesv21
  29. Primary completion date: Dec 2025 to Oct 2026 Completion date: Oct 2028 to Oct 2029 · Study sites revised (21)v20 Show 2 more changesShow less
    • Completion date: Oct 2028 to Oct 2029
    • Study sites revised (21)

    See this version in full on ClinicalTrials.gov ↗

  30. Study Status, Arms and Interventions, Eligibilityv19
  31. Site details revised at 1 of 21 sitesv18
  32. Study sites revised (21)v17 See this version in full on ClinicalTrials.gov ↗
  33. Site contacts updated at 2 of 21 sitesv16
  34. Site details revised at 2 of 21 sitesv15
  35. Site contacts updated at 1 of 21 sites Collaborators: 2 to 4v14 Show 1 more changeShow less
    • Collaborators: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  36. Site contacts updated at 1 of 21 sitesv13
  37. Site details revised at 1 of 21 sitesv12
  38. Site contacts updated at 1 of 21 sitesv11
  39. Site contacts updated at 1 of 21 sitesv10
  40. Site contacts updated at 1 of 21 sitesv9
  41. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2020 to Dec 19, 2019 · Site details revised at 21 of 21 sitesv8 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2020 to Dec 19, 2019
    • Site details revised at 21 of 21 sites
  42. Site contacts updated at 2 of 21 sitesv7
  43. Start date: Nov 2019 to Jan 2020 Primary completion date: Oct 2025 to Dec 2025 · Completion date: Nov 2028 to Oct 2028 · Site contacts updated at 1 of 21 sitesv6 Show 3 more changesShow less
    • Primary completion date: Oct 2025 to Dec 2025
    • Completion date: Nov 2028 to Oct 2028
    • Site contacts updated at 1 of 21 sites
  44. Site contacts updated at 1 of 21 sitesv5
  45. Study sites: 24 to 21v4
  • 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.
This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
Trial Details
NCT Number NCT04047628
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN), Blood and Marrow Transplant Clinical Trials Network, PPD Development, LP, Rho Federal Systems Division, Inc.
Conditions Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov