orwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS

Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital0 个研究点目标入组 264 人开始时间: 2019年5月28日最近更新: 2019年12月16日

试验速览

暂无简介。

•- 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

•- 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

发起方

Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital