Principal Investigator: Øivind Torkildsen
The Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease; The OVERLORD-MS study;
B cell depletion therapies (rituximab, ocrelizumab, ofatumumab) are proven highly effective in MS. A very recent Norwegian health technology assessment (HTA) indicate similar treatment effects from rituximab and ocrelizumab – but clearly, state that more data, preferably from a RCT is needed (https://nyemetoder.no/Documents/Rapporter/disease-modifying-treatments-for-relapsing- remitting-multiple-sclerosis-including-rituximab-hta-rapport-2019.pdf/). Rituximab has been used for the treatment of rheumatologically diseases and haematological cancers since 1998, and due to patency expire, costs only a fraction of ocrelizumab. If rituximab proves to have similar effects as ocrelizumab, it may therefore substantially reduce the annual cost for MS-therapy, and give MS-patients access to highly effective treatment at an earlier time point. In this study, we therefore aim to compare the efficacy and safety of rituximab to ocrelizumab for early treatment in MS.
The objectives of this non-inferiority study are to evaluate if rituximab has comparably efficacy and safety as ocrelizumab in the treatment of newly diagnosed patients with MS.
The primary endpoint of the study is the proportion of patients free of new T2 magnetic resonance imaging (MRI) lesions between month 6 and month 24 (two years).
The study (https://clinicaltrials.gov/ & NCT04578639 is approved by the Regional Committees for Medical and Health Research Ethics Western Norway, and the Norwegian Medicines Agency. The first patient will be included in late October 2020 at Haukeland University Hospital.