Multiple sclerosis
Conditions
Interventions
Trade Name: Ocrevus
Product Name: ocrelizumab
Pharmaceutical Form: Solution for infusion
Sponsors
VU medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria34 • Age of 18 to 60 years • EDSS score of 0 to 6.5 inclusive • Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 296 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Previous treatment with alemtuzumab, cladribine or stem cell transplantation • Relapse in the past 3 months prior to inclusion • Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion • Inability to undergo regular MRI scanning • Women who are pregnant or expect to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.;Secondary Objective: With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of disability and brain atrophy.;Primary end point(s): The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.;Timepoint(s) of evaluation of this end point: 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 96 weeks;Secondary end point(s): • Number of total relapses and annualized relapse rate calculated as the total number of relapses per patient divided by years of follow-up. • Total number of active (new and/or enlarging) T2 lesions on brain MRI at 96 weeks in comparison to the baseline MRI and number of active MRI scans. • Proportion of patients with six month confirmed disability progression on the EDSS at 96 weeks of the two treatment groups. Disability progression is defined as an increase of 1.5 points for a baseline EDSS of 0, an increase of 1 point for baseline EDSS of 1–5.5, and an increase of 0.5 for baseline EDSS >5.5. • Change of MSFC (T25FW, 9HPT and SDMT). • Change of disability measured by two digital apps (MS sherpa and neurokeys) • Rate of brain atrophy comparing baseline MRI and MRI at 96 weeks. • Change of different subsets of the MSFC from baseline to week 96. • Proportion of patients with NEDA at 96 weeks. NEDA is defined as absence of confirmed relapses, MRI disease activity (new/enlarging T2 lesions) and confirmed disability progression. • Change of serum neurofilament light from baseline to highest level during the study. • Change of quality of life measured by the SF-36 and MSIS-29. • Change of burden of treatment measured by the TSQM. • Presence of a possible wearing-off effect measured by a questionnaire developed by the Amsterdam MS Center. • Change of IgG levels. • Number of adverse and serious adverse events including infections (and COVID-19) at 96 weeks. Tertiary research questions When subjects participate in the data collection via the apps Neurokeys and MS Sherpa: - To examine which Neurokeys features are associated with disease status and disease progression - To examine which features of MS Sherpa are associated with disease status and disease progression | — |
Countries
Netherlands
Contacts
Public ContactJoep Killestein
VU medical center
Outcome results
None listed