Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml
Product Name: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Mavenclad tabletter 10 mg
Produ
Sponsors
Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 65 years - A diagnosis of relapsing MS (RMS) according to the 2017 McDonald criteria - Disease activity seen as either a clinical relapse or MRI activity during the last 12 months - EDSS between 0 and 5.5 - Thrombocytes and leukocytes within normal range, and lymphocytes above 0.8 x10 9/L before first dose of study medication A) For women of childbearing potential: accepting to use adequate contraception in the trial period. If randomized to cladribine, women who use systemic hormonal contraception must accept to use additional barrier contraception during each treatment cycle and for four weeks after each treatment cycle. B) For men: If randomized to cladribine, accepting to use adequate contraception in the safety period of 6 months after each treatment cycle. - Able to understand written and spoken Norwegian or English - Able to complete treatment or follow-ups in the study (e.g. contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving) - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 264 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any contraindication or increased risk of side-effects from rituximab or cladribine (such as ongoing acute or chronic infection, live vaccination less than 4 weeks before start of treatment or planned live vaccination, immunocompromised, previous or active malignant disease, ongoing glucocorticoid treatment or allergy against any products of the medication) - Previous use of any of cladribine, rituximab, alemtuzumab, ocrelizumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression with long lasting effects - Current pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to assess whether rituximab is non-inferior to cladribine for the treatment of RMS.;Secondary Objective: Secondly, we will test specific blood samples and MRI biomarkers that may contribute to future personalized treatment for these patients. Furthermore, we want to evaluate the health economic consequences of the two therapies.;Primary end point(s): The primary endpoint is the number of new or enlarging cerebral MRI T2 lesions per patient from week 12 to week 96.;Timepoint(s) of evaluation of this end point: The inclusion period will span 2 years, ensuring a minimum of 264 participating patients across the ten hospitals that are involved so far. Each patient will be followed for 96 weeks, making the maximum total trial period 4 years. Interim analyses will be performed when all patients have participated for 48 weeks, and will serve as a guide for treatment decisions until the final endpoints are met. The evaluation of the primary endpoint will be performed continously through the study, as each patient reaches his/her 96 week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of new or enlarging cerebral MRI T2 lesions per patient from week 12 to week 48 - Annual clinical relapse rate (ARR) at 24, 48 and 96 weeks - Proportion of relapse-free patients at 24, 48 and 96 weeks - Proportion of patients with 24 weeks confirmed disability progression (24-CDP) on EDSS at 48 and 96 weeks - Change in disability (EDSS) at 48 and 96 weeks;Timepoint(s) of evaluation of this end point: Please see the box above. The analyses of the secondary endoints will be performed continously throughout the study for the clinical, MRI and biomarker endpoints. The Health economic analyses will be performed after the full completion of the study for all participants. | — |
Countries
Norway
Contacts
Public ContactHead of Department of Neurology
Oslo University Hospital
Outcome results
None listed