Active — Not RecruitingPhase 3

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

Denmark600 participantsStarted 2021-04-28

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ▪≥2 relapse previous 12 months OR
✓. 1 relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR
✓. 1 relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND
✓. ≥1 relapse previous 12 months OR
✓. ≥1 contrast-enhancing lesion or ≥2 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months
✓. ≥1 relapse previous 12 months OR
✓. ≥1 contrast-enhancing lesion previous 12 months or ≥1 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months or ≥2 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 24 months OR
✓. Increased levels of neurofilament light chain (NFL) in serum or cerebrospinal fluid (CSF) in sample collected previous 12 months. Progressive MS patients not fulfilling the clinical/MRI criteria for active disease, may qualify for inclusion in the study if:

What they're measuring

Percentage of patients without new or enlarging T2 white matter lesions on brain MRI scans

Timeframe: Month 6 to month 24

Trial details

NCT IDNCT04688788

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-05

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