Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS

Recruiting Phase 3 Interventional Study
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Amsterdam UMC, location VUmc · Other
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About This Trial
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 demonst…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Men and women aged 18 years and older 2. A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria 3. Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of rela…
Contacts

Lisa Schoof, Msc

650087853

l.g.schoof@amsterdamumc.nl

CONTACT

Eva Strijbis, Dr.

204442182

e.strijbis@amsterdamumc.nl

CONTACT