Disease: Multiple Sclerosis
Type of study: Interventional trial
Coordinating investigator: Øivind Torkildsen
Study director: Kjell-Morten Myhr
Information for patients: on this page (Norwegian only)
Background: B-cell depletion therapies (rituximab, ocrelizumab, ofatumumab) are proven highly effective in MS. A Norwegian health technology assessment (HTA) indicate similar treatment effects from rituximab and ocrelizumab – but clearly state that more data, preferably from a randomised double-blinded clinical trial, is needed.
Rituximab has been used for the treatment of rheumatological diseases and haematological cancers since 1998, and due to patency expiration, costs only a fraction of ocrelizumab. If rituximab proves similar effects as ocrelizumab, it may therefore reduce the annual cost for MS-therapy by several hundred million NOK in Norway alone and give MS-patients access to highly effective treatment at an earlier timepoint. In this study, we therefore aim to compare the efficacy and safety of rituximab to ocrelizumab for treatment of newly diagnosed treatment naïve patients with RRMS.
The objective is to evaluate whether rituximab has comparably efficacy and safety as ocrelizumab in the treatment of newly diagnosed RRMS patients.
Design: This is a randomised, double-blinded, controlled non-inferiority trial comparing the efficacy and safety of rituximab to ocrelizumab (3:2) in newly diagnosed RRMS.
The primary endpoint of the study is the proportion of patients free of new T2 magnetic resonance imaging (MRI) lesions between month 6 (re-baseline examination) and month 24 (two years).
Status: The first patient was recruited at Haukeland University Hospital in early November 2020 and the study was fully included by November 2022, with 214 patients participating. Altogether, 12 hospitals in Norway and Sweden have recruited patients in the study and participate in the follow-up.
Participating centres
Norway
- Haukeland University Hospital, Bergen
- Oslo University Hospital, Oslo
- Akershus University Hospital, Lørenskog
- Stavanger University Hospital, Stavanger
- University Hospital of North Norway, Tromsø
- Nordland Hospital Trust, Bodø
- Namsos Hospital Trust, Namsos
- Molde Hospital Trust, Molde
- Sørlandet Hospital Trust, Kristiansand
- Telemark Hospital Trust, Skien
- Vestre Viken Hospital Trust, Drammen
Sweden
- Karolinska Institute, Stockholm
Funding
- KLINBEFORSK
- The Regional Health Authority of Western Norway
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Participating hospitals