Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04075266 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 51 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Dec 1, 2029 to Apr 26, 2032 Secondary endpoints: details revised at 11 of 17 entries · Eligibility criteria shortened, about 3 wordsv51 Show 2 more changesShow less
    • Secondary endpoints: details revised at 11 of 17 entries
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. 3 versions Re-verified since Jun 10, 2025, no change to tracked fieldsv48-v50
  3. Study sites revised (12)v47 See this version in full on ClinicalTrials.gov ↗
  4. Results first posted: Nov 8, 2024 Primary endpoints: 2 to 3 · Secondary endpoints: 10 to 17v46 Show 2 more changesShow less
    • Primary endpoints: 2 to 3
    • Secondary endpoints: 10 to 17

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 36 to 23v45
Show 43 earlier versionsHide 43 earlier versions
  1. 2 versions Re-verified since Mar 15, 2024, no change to tracked fieldsv43-v44
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 24 to 12 · Primary completion date changed from estimate of Dec 31, 2023 to Oct 5, 2023v42 Show 2 more changesShow less
    • Study sites: 24 to 12
    • Primary completion date changed from estimate of Dec 31, 2023 to Oct 5, 2023
  3. Site details revised at 1 of 24 sitesv41
  4. Site details revised at 3 of 24 sitesv40
  5. Site details revised at 1 of 24 sitesv39
  6. Site details revised at 1 of 24 sitesv38
  7. Site details revised at 2 of 24 sitesv37
  8. Re-verified, no change to tracked fieldsv36
  9. Site details revised at 5 of 24 sitesv35
  10. Primary completion date: Jun 30, 2024 to Dec 31, 2023 Completion date: Jan 12, 2027 to Dec 1, 2029v34 Show 1 more changeShow less
    • Completion date: Jan 12, 2027 to Dec 1, 2029
  11. Study sites: 23 to 24v33
  12. Re-verified, no change to tracked fieldsv32
  13. Study sites revised (23)v31 See this version in full on ClinicalTrials.gov ↗
  14. Re-verified, no change to tracked fieldsv30
  15. Primary completion date: Dec 31, 2022 to Jun 30, 2024v29
  16. Primary completion date: Dec 1, 2022 to Dec 31, 2022v28
  17. 6 versions Re-verified since Jun 3, 2022, no change to tracked fieldsv22-v27
  18. Site details revised at 1 of 23 sitesv21
  19. Site details revised at 4 of 23 sitesv20
  20. Site details revised at 5 of 23 sitesv19
  21. Primary completion date: Jan 31, 2022 to Dec 1, 2022 Completion date: Aug 12, 2025 to Jan 12, 2027 · Site details revised at 1 of 23 sitesv18 Show 2 more changesShow less
    • Completion date: Aug 12, 2025 to Jan 12, 2027
    • Site details revised at 1 of 23 sites
  22. Site details revised at 1 of 23 sitesv17
  23. Site details revised at 2 of 23 sitesv16
  24. Site details revised at 1 of 23 sitesv15
  25. Site details revised at 1 of 23 sitesv14
  26. 2 versions Re-verified since Mar 29, 2021, no change to tracked fieldsv12-v13
  27. Enrollment target: 12 to 36 Primary completion date: May 26, 2021 to Jan 31, 2022v11 Show 1 more changeShow less
    • Primary completion date: May 26, 2021 to Jan 31, 2022
  28. Re-verified, no change to tracked fieldsv10
  29. Study sites: 22 to 23v9
  30. Eligibility criteria expanded, about 62 words Secondary endpoints revised (10) · Site details revised at 2 of 22 sitesv8 Show 2 more changesShow less
    • Secondary endpoints revised (10)
    • Site details revised at 2 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  31. Site details revised at 3 of 22 sitesv7
  32. Completion date: Sep 2, 2025 to Aug 12, 2025 Start date changed from estimate of Dec 11, 2019 to Jan 9, 2020v6 Show 1 more changeShow less
    • Start date changed from estimate of Dec 11, 2019 to Jan 9, 2020
  33. Site details revised at 1 of 22 sitesv5
  34. Trial status: Not Yet Recruiting to Recruiting Study sites: 18 to 22v4 Show 1 more changeShow less
    • Study sites: 18 to 22
  35. Re-verified, no change to tracked fieldsv3
  36. Completion date: Aug 19, 2025 to Sep 2, 2025 Start date: Nov 27, 2019 to Dec 11, 2019v2 Show 1 more changeShow less
    • Start date: Nov 27, 2019 to Dec 11, 2019
  • 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 12-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.
Trial Details
NCT Number NCT04075266
Lead Sponsor Hoffmann-La Roche
Conditions Multiple Sclerosis
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov