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A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

Study acronym: SOSTOS
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv25
  2. Primary completion pushed from Dec 31, 2026 to Apr 13, 2027 Completion pushed from Mar 1, 2027 to Apr 13, 2027 · Site details revised at 1 of 43 sitesv24 Show 2 more changesShow less
    • Completion pushed from Mar 1, 2027 to Apr 13, 2027
    • Site details revised at 1 of 43 sites
  3. Site details revised at 1 of 43 sitesv23
  4. Site details revised at 1 of 43 sitesv22
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 150 to confirmed 136 · Completion date: Dec 31, 2026 to Mar 1, 2027 · Site details revised at 43 of 43 sitesv21 Show 3 more changesShow less
    • Enrollment target: estimated 150 to confirmed 136
    • Completion date: Dec 31, 2026 to Mar 1, 2027
    • Site details revised at 43 of 43 sites
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 42 to 43v20
  2. Study sites: 41 to 42v19
  3. Re-verified, no change to tracked fieldsv18
  4. Study sites: 40 to 41v17
  5. Study sites: 37 to 40v16
  6. Study sites revised (37)v15 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 34 to 37 Primary and study completion dates: Jan 27, 2027 to Dec 31, 2026v14 Show 1 more changeShow less
    • Primary and study completion dates: Jan 27, 2027 to Dec 31, 2026
  8. Primary and study completion dates: Jul 21, 2027 to Jan 27, 2027 Study sites revised (34)v13 Show 1 more changeShow less
    • Study sites revised (34)

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 33 to 34v12
  10. Primary and study completion dates: Feb 20, 2026 to Jul 21, 2027 Study sites revised (33)v11 Show 1 more changeShow less
    • Study sites revised (33)

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 28 to 33v10
  12. Study sites: 24 to 28v9
  13. Study sites: 14 to 24 Primary and study completion dates: Nov 20, 2025 to Feb 20, 2026v8 Show 1 more changeShow less
    • Primary and study completion dates: Nov 20, 2025 to Feb 20, 2026
  14. Study sites: 9 to 14v7
  15. Primary and study completion dates: Mar 20, 2025 to Nov 20, 2025 Study sites: 2 to 9v6 Show 1 more changeShow less
    • Study sites: 2 to 9
  16. Study sites: 1 to 2v5
  17. Re-verified, no change to tracked fieldsv4
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Feb 28, 2022 to Mar 2, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 28, 2022 to Mar 2, 2022
  19. Start date: Nov 15, 2021 to Feb 28, 2022 Primary and study completion dates: Oct 30, 2024 to Mar 20, 2025v2 Show 1 more changeShow less
    • Primary and study completion dates: Oct 30, 2024 to Mar 20, 2025
  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.
Novartis
555 trials monitored
See 31 trials at risk
Multiple Sclerosis
991 trials monitored
See 36 trials at risk
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Trial Details
NCT Number NCT05090371
Lead Sponsor Novartis Pharmaceuticals
Conditions Relapsing-Remitting Multiple Sclerosis
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov