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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Study acronym: MUSETTE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion moved earlier from Aug 31, 2028 to Feb 21, 2028 Eligibility criteria expanded, about 38 words · Secondary endpoints: details revised at 13 of 16 entries · Site details revised at 4 of 120 sites · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 13 of 16 entries
    • Site details revised at 4 of 120 sites
    • Publications: details revised at 1 of 1 entry
  2. Study sites revised (120)v49 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 122 to 120v48
  4. Results first posted: Feb 17, 2026 Secondary endpoints revised (16)v47 Show 1 more changeShow less
    • Secondary endpoints revised (16)

    See this version in full on ClinicalTrials.gov ↗

  5. Secondary endpoints: 15 to 16 Study sites revised (122)v46 Show 1 more changeShow less
    • Study sites revised (122)

    See this version in full on ClinicalTrials.gov ↗

Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 1 of 122 sitesv45
  2. Site details revised at 1 of 122 sitesv44
  3. Site details revised at 8 of 122 sitesv43
  4. Study sites: 126 to 122v42
  5. Primary endpoint revised Eligibility criteria shortened, about 14 words · Secondary endpoints: 20 to 15 · Study sites revised (126) · 2 morev41 Show 5 more changesShow less
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 20 to 15
    • Study sites revised (126)
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites revised (126)v40 See this version in full on ClinicalTrials.gov ↗
  7. Re-verified, no change to tracked fieldsv39
  8. Primary endpoint revised Enrollment target: estimated 865 to confirmed 864 · Primary completion date: Mar 3, 2025 to Dec 19, 2024 · Eligibility criteria shortened, about 9 words · 1 morev38 Show 4 more changesShow less
    • Enrollment target: estimated 865 to confirmed 864
    • Primary completion date: Mar 3, 2025 to Dec 19, 2024
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints revised (20)

    See this version in full on ClinicalTrials.gov ↗

  9. Secondary endpoints: 18 to 20 Study sites revised (126)v37 Show 1 more changeShow less
    • Study sites revised (126)

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites revised (126)v36 See this version in full on ClinicalTrials.gov ↗
  11. Re-verified, no change to tracked fieldsv35
  12. Study sites revised (126)v34 See this version in full on ClinicalTrials.gov ↗
  13. Study sites revised (126)v33 See this version in full on ClinicalTrials.gov ↗
  14. Re-verified, no change to tracked fieldsv32
  15. Trial status: Recruiting to Active, Not Recruiting Study sites: 203 to 126 · Primary completion date: Jul 18, 2025 to Mar 3, 2025 · Completion date: Mar 30, 2029 to Aug 31, 2028v31 Show 3 more changesShow less
    • Study sites: 203 to 126
    • Primary completion date: Jul 18, 2025 to Mar 3, 2025
    • Completion date: Mar 30, 2029 to Aug 31, 2028
  16. Study sites revised (203)v30 See this version in full on ClinicalTrials.gov ↗
  17. Trial status: Active, Not Recruiting to Recruiting Study sites: 126 to 203v29 Show 1 more changeShow less
    • Study sites: 126 to 203
  18. Study sites revised (126)v28 See this version in full on ClinicalTrials.gov ↗
  19. Primary completion date: Aug 20, 2024 to Jul 18, 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 786 to confirmed 865 · Study sites: 203 to 126 · 1 morev27 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 786 to confirmed 865
    • Study sites: 203 to 126
    • Completion date: May 15, 2028 to Mar 30, 2029
  20. Trial status: Active, Not Recruiting to Recruiting Study sites: 126 to 203v26 Show 1 more changeShow less
    • Study sites: 126 to 203
  21. Trial status: Recruiting to Active, Not Recruiting Study sites: 203 to 126v25 Show 1 more changeShow less
    • Study sites: 203 to 126
  22. Site details revised at 3 of 203 sitesv24
  23. Site details revised at 3 of 203 sitesv23
  24. Study sites revised (203)v22 See this version in full on ClinicalTrials.gov ↗
  25. Site details revised at 17 of 203 sitesv21
  26. Site details revised at 10 of 203 sitesv20
  27. Trial status: Active, Not Recruiting to Recruiting Study sites: 127 to 203v19 Show 1 more changeShow less
    • Study sites: 127 to 203
  28. Study sites: 126 to 127v18
  29. Trial status: Recruiting to Active, Not Recruiting Study sites: 203 to 126 · Primary completion date: Jun 7, 2024 to Aug 20, 2024v17 Show 2 more changesShow less
    • Study sites: 203 to 126
    • Primary completion date: Jun 7, 2024 to Aug 20, 2024
  30. Study sites revised (203)v16 See this version in full on ClinicalTrials.gov ↗
  31. Trial status: Active, Not Recruiting to Recruiting Study sites: 128 to 203 · Secondary endpoints revised (18)v15 Show 2 more changesShow less
    • Study sites: 128 to 203
    • Secondary endpoints revised (18)

    See this version in full on ClinicalTrials.gov ↗

  32. Trial status: Recruiting to Active, Not Recruiting Study sites: 203 to 128v14 Show 1 more changeShow less
    • Study sites: 203 to 128
  33. Study sites revised (203)v13 See this version in full on ClinicalTrials.gov ↗
  34. Site details revised at 30 of 203 sitesv12
  35. Primary completion date: Feb 23, 2025 to Jun 7, 2024 Completion date: Aug 15, 2028 to May 15, 2028 · Site details revised at 22 of 203 sitesv11 Show 2 more changesShow less
    • Completion date: Aug 15, 2028 to May 15, 2028
    • Site details revised at 22 of 203 sites
  36. Study sites: 212 to 203v10
  37. Eligibility criteria shortened, about 9 words Secondary endpoints revised (18) · Site details revised at 12 of 212 sitesv9 Show 2 more changesShow less
    • Secondary endpoints revised (18)
    • Site details revised at 12 of 212 sites

    See this version in full on ClinicalTrials.gov ↗

  38. Study sites: 213 to 212v8
  39. Primary endpoint revised Study sites: 219 to 213 · Eligibility criteria expanded, about 135 words · Secondary endpoints: 19 to 18v7 Show 3 more changesShow less
    • Study sites: 219 to 213
    • Eligibility criteria expanded, about 135 words
    • Secondary endpoints: 19 to 18

    See this version in full on ClinicalTrials.gov ↗

  40. Study sites: 218 to 219v6
  41. Study sites revised (218)v5 See this version in full on ClinicalTrials.gov ↗
  42. Study sites: 213 to 218 Start date changed from estimate of Dec 15, 2020 to Nov 26, 2020v4 Show 1 more changeShow less
    • Start date changed from estimate of Dec 15, 2020 to Nov 26, 2020
  43. Trial status: Not Yet Recruiting to Recruiting Study sites: 188 to 213 · Completion date: Aug 8, 2028 to Aug 15, 2028 · Start date: Nov 17, 2020 to Dec 15, 2020v3 Show 3 more changesShow less
    • Study sites: 188 to 213
    • Completion date: Aug 8, 2028 to Aug 15, 2028
    • Start date: Nov 17, 2020 to Dec 15, 2020
  44. Primary endpoint revised Study sites: 145 to 188 · Primary completion date: Apr 20, 2025 to Feb 23, 2025 · Completion date: Jan 23, 2029 to Aug 8, 2028 · 3 morev2 Show 6 more changesShow less
    • Study sites: 145 to 188
    • Primary completion date: Apr 20, 2025 to Feb 23, 2025
    • Completion date: Jan 23, 2029 to Aug 8, 2028
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 14 of 19 entries
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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.
This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
Trial Details
NCT Number NCT04544436
Lead Sponsor Hoffmann-La Roche
Conditions Multiple Sclerosis
Enrollment 864 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov