Disease: Multiple Sclerosis
Type of study: Observational trial
Coordinating investigator: Brit Ellen Rød
Study directors: Gro Owren Nygaard (OUH) & Stig Wergeland
Background: Norwegian MS treatment guidelines recommend prompt treatment with high efficacy therapy at the time of diagnosis. Cladribine and rituximab are among the recommended high-efficacy therapy treatment options. Cladribine has not been compared to other active therapies in clinical trials, and the extension of the pivotal placebo-controlled trial indicate return of new clinical and MRI disease activity after standard treatment regimens during the first and second year.
Clinical experience confirms these findings, and based on this background, we aim to compare prospective collected data from patient cohorts from the Departments of Neurology at Haukeland University Hospital (HUH) and Oslo University Hospital (OUH), who started with rituximab or cladribine therapy during 2018 and 2019. At that time point, rituximab was the preferred high-efficacy therapy at HUH for both treatment-naïve patients and for those experiencing breakthrough disease activity on other therapies. At OUH, cladribine was the preferred high-efficacy therapy for the same patient populations. The objectives of this study are to compare the efficacy and safety of cladribine and rituximab therapy.
Design: This is a prospective observational registry study comparing the efficacy and safety of cladribine and rituximab therapy for treatment naïve RRMS patients and for those switching from other therapies.
The primary endpoint of the study is the proportion of patients who develop new MRI disease activity during up to a four-year observational period.
Status: The study has received all approvals from the ethical committee and the Norwegian MS-Registry. Data has been collected and results from the analyses
will be presented at the annual meeting of the Norwegian Neurological Association in March 2024.
Participating centres
- Haukeland University Hospital, Bergen
- Oslo University Hospital
Funding
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- Oslo University Hospital
- The DAM foundation
- The Norwegian MS Society
- The Torbjørg Hauge Legacy, University of Bergen
- The University of Bergen
- The University of Oslo
- The Kjell Alme Legacy, Bergen