Efficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MS

Medical University of Vienna - Department of Neurology0 个研究点目标入组 70 人开始时间: 2018年3月12日最近更新: 2018年9月10日

适应症

试验速览

暂无简介。

•Signed informed consent obtained before any trial related activities
•Ability to understand the nature and the purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the trial
•In female subjects either childbearing potential terminated by surgery or one year post- menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
•Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
•Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
•Diagnosis of RR-MS and existing or planned rituximab treatment
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Patients with HepBc antibodies
•Clinically relevant infection (<1 week)
•Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory or neurological diseases, that may interfere with the aim of the study
•Ascertained or presumed hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or major allergic reactions in general, which the investigator considers may compromise the safety of the participants
•Use of medication during 2 weeks before the start of the study, which the investigator considers may affect the validity of the study
•Drug abuse, alcohol (>1 drinks/day, defined according to USDA Dietary Guidelines)
•Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential

发起方

Medical University of Vienna - Department of Neurology