Actively Recruiting
Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS
Led by Amsterdam UMC, location VUmc · Updated on 2023-04-28
200
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
S
Stichting Treatmeds
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints) Nature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.
CONDITIONS
Official Title
Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years and older
- Diagnosed with relapsing multiple sclerosis according to the 2017 revised criteria
- Recommended to start anti-CD20 therapy by a neurologist as per Dutch treatment guidelines
- Able to understand written and spoken Dutch or English
- Able to provide signed informed consent and comply with study requirements
- Screening Expanded Disability Status Scale (EDSS) score of 6.5 or less
You will not qualify if you...
- Allergy or intolerance to rituximab, ocrelizumab, gadolinium-based MRI contrast agents, or corticosteroids
- Diagnosis of primary progressive MS
- Diagnosis of non-active secondary progressive MS
- Chronic infections such as tuberculosis, varicella-zoster virus, hepatitis B or C, or HIV
- History of inflammatory bowel disease like Crohn's disease or ulcerative colitis
- Psychiatric illness or cognitive dysfunction affecting consent or compliance
- Cardiac disease contraindicating treatment with rituximab or ocrelizumab
- Active or prior malignancy contraindicating treatment with rituximab or ocrelizumab
- White blood cell count below 1.5 x 10^9/L unless reversible
- Platelet count below 100 x 10^9/L
- Elevated liver enzymes (ALAT or ASAT) more than twice the upper normal limit
- Serum creatinine above 200 µmol/L
- Serum bilirubin above normal limit
- Serum IgG below lower normal limit
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective birth control
- History of serious infusion reactions to rituximab or ocrelizumab
- Use of glucocorticoids or ACTH within one month before study start
- Previous use of certain second-line MS therapies or immunosuppressants with lasting effects (exceptions apply)
- Current use of systemic immunosuppressive medication except corticosteroids for relapse symptoms
- Participation in another investigational drug or device study within 30 days or ongoing
- Current alcohol or drug dependence
- Presence of metallic implants preventing safe MRI
- Unwillingness to undergo MRI scans with intravenous gadolinium contrast
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location VUmc
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
Research Team
L
Lisa Schoof, Msc
CONTACT
E
Eva Strijbis, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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