TrialBridgeNCT05834855
Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS
Recruiting · Phase 3 · Amsterdam UMC, location VUmc · registry updated 2023-04-28
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)....
Inclusion
- Men and women aged 18 years and older
- A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria
- Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS
- Able to understand written and spoken Dutch or English
- Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Screening EDSS score ≤ 6.5 .
Exclusion
- Medical Conditions
- A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids.
- A diagnosis of primary progressive MS according to the diagnostic criteria.
- A diagnosis of not-active secondary progressive MS.
- Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and/or hepatitis C PCR positivity verified at screening visit.
- A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis