Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years

CHU de Rennes0 个研究点目标入组 250 人开始时间: 2018年6月5日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•- Patients > or = 50 years old ;
•- Secondary progressive phenotype for at least 3 years ;
•The secondary progressive phenotype will be defined as progressive deterioration of disability not due to relapse, with an increase of at least 1 EDSS point since the beginning of the progressive phase (or 0.5 EDSS point if EDSS score = 5.5).
•- Disease modifying therapy of MS for at least 3 years (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, fingolimod, natalizumab, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil); Both patients with the same DMT or with successive DMTs during 3 years can be included;
•- No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan) ;
•- EDSS = 3.
•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 225
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•- Patients treated with mitoxantrone, alentuzumab, rituximab or ocrelizumab during the previous 3 years before inclusion;
•- Change of disease modifying therapy of MS for less than a year
•- Other neurological or systemic disease ;
•- Incapacity to understand or sign the consent form ;
•- Contraindication to MRI ;
•- Pregnancy or breast-feeding ;
•- Patient in another clinical trial
•- Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (eg minors, protected adults, …).

发起方

CHU de Rennes