Condition: Multiple Sclerosis · Multiple Sclerosis, Relapsing-Remitting · Demyelinating Autoimmune Diseases, CNS · Sponsor: Amsterdam UMC, location VUmc
Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy. Objective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS. Study design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months Study population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment. Intervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment). Main study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and numb…
This description comes directly from the study's public registry record.
Lisa Schoof, Msc · 650087853 · l.g.schoof@amsterdamumc.nl
Eva Strijbis, Dr. · 204442182 · e.strijbis@amsterdamumc.nl
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| Amsterdam UMC, location VUmc | Amsterdam, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05834855