Background and vision
Running clinical trials is pivotal to advance the treatment of multiple sclerosis. The Norwegian MS Competence Centre and research group strives to investigate the efficacy and safety of new and upcoming treatment options, and will have a close collaboration also with the newly established Neuro-SysMed research centre at Haukeland University Hospital.
Randomized Autologous heMatopoietic stem cell transplantation versus Alemtuzumabfor patients with relapsing remitting Multiple Sclerosis (RAM-MS)
The objective is to investigate the efficacy and the safety of HSCT compared to other high efficacy treatment in patients with aggressive relapsing remitting MS. The primary efficacy endpoint is to determine differences between patients in the two treatment arms according to the proportion of patients with no evidence of disease activity (NEDA) during a 2 year (96 week) period, with a 5 year (240 week) pre-planned study extension. The method is a prospective multicentre, interventional, unblinded, randomized, parallel group study.
Time frame: The first inclusion was in February 2018, and the anticipated recruitment period is 3 years.
Coordinating investigator: Lars Bø
Phone: (+47) 55 97 61 86 / 974 32 421
Primary investigator: Øivind Fredvik Grytten Torkildsen
Study home page: www.ram-ms.no
Study of Mesenchymal Autologous stem cells as Regenerative Treatment for Multiple Sclerosis (SMART-MS)
Multiple Sclerosis (MS) is a disease that causes loss of nerve fiber insulation (myelin) in the central nervous system, with secondary nerve fiber (axon) damage. Over time, this often leads to persistent neurological symptoms and disability. There is no effective treatment available to directly promote repair of damage to the central nervous system and thereby reverse neurological disability.
Studies using animal models have shown that mesenchymal stem cells (MSCs) have the potential to induce neuronal repair through multiple regenerative mechanisms, including re-myelination, modulation of the immune response and secretion of neural growth factors.
The objective in SMART-MS is to investigate the possible regenerative treatment effect of MSCs in patients with progressive MS. We aim to start early 2021 and to include 18 patients over the next 2 years.We plan to use lumbar puncture (intrathecal) injection as administration method to optimize the chances of a positive treatment effect. All patients will receive MSCs in a randomized, placebo-controlled, cross-over design and followed over a timeframe of 1 year.
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) indicates 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.