A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.

Department of Clinical Sciences, Danderyd Hospital0 个研究点目标入组 200 人开始时间: 2015年10月20日最近更新: 2023年10月9日

适应症

试验速览

暂无简介。

•A subject will be eligible for inclusion in this study if all of the following criteria apply:
•Diagnosis of Relapsing Remitting MS according to the 2017 revised McDonald criteria OR one demyelinating episode in conjunction with at least one asymptomatic high intensity T2 lesion with size and location compatible with MS
•Untreated OR treated with first line injectables (interferon or glatiramer acetate)
•Between the age of 18 and 50 years (inclusive) of age
•No more than 10 years of disease duration (since MS diagnosis)
•During the previous year, clinical or radiological disease activity defined as at least one of the following:
•o = 1 relapse
•o = 2 T2 lesions
•o = 1 Gd+ lesions
•EDSS 0 – 5,5 (inclusive)
•In fertile females, willing to comply with effective contraceptive methods. These include birth control pills, surgical sterilization of patient or partner or intrauterine device. Non-fertile women is defined as more than 12 months of amenorrhea
•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 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A subject will not be eligible for inclusion in this study if any of the following criteria ap-plies:
•Diagnosis of Progressive MS
•Pregnant or lactating women
•Patients having contraindication for or otherwise not compliant with MRI investigations
•Simultaneous treatment with other immunosuppressive drugs
•Documented allergy or intolerance to any of the IP:s
•Severe psychiatric condition

发起方

Department of Clinical Sciences, Danderyd Hospital