Disease: Multiple Sclerosis
Type of study: Interventional trial
Coordinating investigator: Øivind Torkildsen
Study director: Kjell-Morten Myhr
Follows the OVERLORD-MS study.
Background: B-cell depletion therapies are proven highly effective in MS. Real world data indicate similar efficacy and safety of rituximab compared to ocrelizumab. Currently several ongoing non-inferiority trials are comparing the two compounds, including the Norwegian OVERLORD-MS study.
According to the OVERLORD-MS study protocol, all patients will be offered routine treatment with rituximab after finishing 30 months of blinded therapy with ocrelizumab or rituximab. Because of limited data available describing the efficacy and safety of a switch from ocrelizumab to rituximab, we will perform a blinded six-month observation of starting on rituximab after finishing the 30 months study period with ocrelizumab or rituximab in the OVERLORD-MS study.
The objective is to evaluate the efficacy and safety of switching therapy from ocrelizumab to rituximab.
Design: This is a blinded observation study evaluating the efficacy and safety of switching therapy from ocrelizumab to rituximab.
The primary endpoint of the study is the proportion of patients free of clinical disease during the following 6 months after switching from ocrelizumab to rituximab (n=85) compared to those that continue rituximab therapy as received during the OVERLORD-MS study (n=129).
Status: All patients in the OVERLORD-MS study consenting for participation are consecutively included when finishing the pre-planned 30 months study period of OVERLORD-MS. The last patient will be included in May 2025 and followed for another six months.
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