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Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis

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

Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date: May 5, 2026 to Jun 10, 2026
    • Study completion date: May 5, 2029 to Jun 10, 2029
    v10
  3. Study completion date: May 5, 2028 to May 5, 2029v9
  4. Trial status: Recruiting to Active, Not Recruitingv8 Show 6 more changesShow less
    • Enrollment target: estimated 594 to confirmed 600
    • Primary completion date: Dec 31, 2025 to May 5, 2026
    • Study completion date: Dec 31, 2028 to May 5, 2028
    • Study description expanded, about 16 words
    • Site details revised at 11 of 11 sites
    • Collaborators: 14 to 15
  5. Primary completion date: Apr 28, 2025 to Dec 31, 2025v7 Show 4 more changesShow less
    • Study sites: 12 to 11
    • Study completion date: Apr 28, 2028 to Dec 31, 2028
    • Eligibility criteria expanded, about 57 words
    • Collaborators: 15 to 14
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 6 of 12 sitesv6
  2. Site details revised at 3 of 12 sitesv5
  3. Primary completion date: Jan 15, 2025 to Apr 28, 2025
    • Study completion date: Jan 15, 2028 to Apr 28, 2028
    • Eligibility criteria expanded, about 54 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 29, 2021 to Apr 28, 2021
    • Site details revised at 12 of 12 sites
    v3
  5. Start date: Jan 15, 2021 to Mar 29, 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The DanNORMS study is a phase 3, non-inferiority clinical trial examining whether treatment of active multiple sclerosis with rituximab is non-inferior to ocrelizumab regarding efficacy and safety.
Trial Details
NCT Number NCT04688788
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Collaborators: Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Herlev Hospital, Hillerod Hospital, Denmark, Kolding Sygehus, Gødstrup Hospital, Hvidovre University Hospital, Hospital of South West Jutland, Esbjerg, Denmark, University of Copenhagen, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Hospital of Southern Jutland, Hospital of Central Denmark Region, Viborg, Denmark, Danske Regioner, Sanquin Research & Blood Bank Divisions
Conditions
(from sponsor)		 Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
Related terms Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov